EIN Presswire: H1N1 Press Releases

Polio eradication shifts into emergency mode

Thu, 24 May 2012 10:30:00 +0000

Polio eradication shifts into emergency mode

PR Newswire

- New cases at lowest levels ever, but funding gap threatens progress

GENEVA, May 24, 2012 /PRNewswire/ -- Despite the dramatic drop in polio cases in the last year, the threat of continued transmission due to funding and immunization gaps has driven the Global Polio Eradication Initiative (GPEI) to launch an Emergency Action Plan.

The plan aims to boost vaccination coverage in Nigeria, Pakistan and Afghanistan, the three remaining polio endemic countries, to levels needed to stop polio transmission. In parallel, health ministers meeting at the World Health Assembly this week are considering a resolution to declare "the completion of polio eradication to be a programmatic emergency for global public health," in an acknowledgement of the urgency of the situation.

Polio eradication activities resulted in several landmark successes in 2010-2012. India, long-regarded as the nation facing the greatest challenges to eradication, was removed from the list of polio-endemic countries in February 2012. Outbreaks in previously polio-free countries were nearly all stopped.

Although the number of polio cases was lower in the first four months of this year than during the same period in any other year, cases continue to occur in Nigeria, Pakistan, Afghanistan, and Chad. Outbreaks in recent years in China and West Africa due to importations from Pakistan and Nigeria, respectively, highlight the continued threat of resurgence. By some estimates, failure to eradicate polio could lead within a decade to as many as 200,000 paralyzed children a year worldwide.

"Polio eradication is at a tipping point between success and failure," said Dr. Margaret Chan, Director-General of the World Health Organization. "We are in emergency mode to tip it towards success - working faster and better, focusing on the areas where children are most vulnerable."

Once achieved, polio eradication would generate net benefits of US $40-50 billion globally by 2035, with the bulk of savings in the poorest countries, calculated based on investments made since the Global Polio Eradication Initiative (GPEI) was formed and savings from reduced treatment costs and gains in productivity.

"We know polio can be eradicated, and our success in India proves it," said Kalyan Banerjee, president of Rotary International, a global humanitarian service organization. "It is now a question of political and societal will. Do we choose to deliver a polio-free world to future generations, or do we choose to allow 55 cases this year to turn into 200,000 children paralyzed for life, every single year?"

Full funding of new plan critical

Already, funding shortages have forced the GPEI to cancel or scale-back critical vaccination activities in 24 high-risk countries. This leaves more children vulnerable to contracting the disease, and exposes polio-free countries to the risk of re-emergence.

"All our efforts are at risk until all children are fully immunized against polio – and that means fully funding the global eradication effort and reaching the children we have not yet reached," said UNICEF Executive Director Anthony Lake. "We have come so far in the battle against this crippling disease. We can now make history – or later be condemned by history for failing."

Full implementation of the Emergency Action Plan (EAP) is currently hindered by a critical funding gap of nearly US$1 billion through 2013.

"We are all responsible for creating a polio-free world while we still can," said Chris Elias, president of global development at the Bill & Melinda Gates Foundation. "Achieving this goal is a critical step in protecting all children from vaccine-preventable diseases."

The Global Emergency Action Plan

The global EAP was developed in coordination with new country national emergency plans. The plan builds on India's successes and outlines a range of new strategies and initiatives to better support eradication efforts, including:

Intensified focus on worst-performing areas of Nigeria, Pakistan and Afghanistan to increase vaccination coverage by end of 2012 to levels needed to stop transmission;
New approaches tailored to each country to tackle persistent challenges and improve polio vaccination campaign performance;
Heightened accountability, coordination and oversight to ensure success at every level of government and within every partner agency and organization.
Surge of technical assistance and social mobilization capacity.

Working in emergency mode

"We need everyone's commitment and hard work to eradicate polio and cross the finish line," said Dr. Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC). "It won't be easy, but together we can eradicate polio forever and for everyone."

Already since the start of the year, the GPEI has moved its operations into emergency mode. CDC has activated its Emergency Operations Center; UNICEF has officially activated an Interdivisional Emergency Coordinating Committee operating directly under the Deputy Executive Director; and WHO has moved its polio operations to its Strategic Health Operations Centre (SHOC). Such measures are reserved for responding to global health emergencies -- such as the H1N1 pandemic or the 2004 Southeast Asia tsunami -- and will enable a massive surge in technical capacity, real-time tracking of program performance and the immediate implementation of corrective action plans as necessary. Also this year, the Trustees of the Rotary Foundation reaffirmed polio eradication as the organization's most urgent priority. In addition, Rotary senior leaders have launched a series of one-on-one meetings with the heads of state of the polio endemic countries.

Notes for editors:

The Global Polio Eradication Initiative (GPEI) is spearheaded by national governments, the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF, and supported by key partners including the Bill & Melinda Gates Foundation.

Since 1988 (the year the GPEI was launched), the incidence of polio has been reduced by more than 99%. In 1988, more than 350,000 children were paralyzed each year in more than 125 endemic countries. In 2012, 55 cases have been reported (as of 15 May 2012), and only three countries remain endemic: Nigeria, Pakistan and Afghanistan.

Links to:

Global Emergency Action Plan (EAP) 2012-2013
Country fact sheets: Nigeria, Pakistan, Afghanistan
Funding gap
Infographic
B-roll

Polio eradication shifts into emergency mode

Thu, 24 May 2012 10:30:00 +0000

Polio eradication shifts into emergency mode

PR Newswire

New cases at lowest levels ever, but funding gap threatens progress

GENEVA, May 24, 2012 /PRNewswire-USNewswire/ -- Despite the dramatic drop in polio cases in the last year, the threat of continued transmission due to funding and immunization gaps has driven the Global Polio Eradication Initiative (GPEI) to launch an Emergency Action Plan.

Full funding of new plan critical

Full implementation of the Emergency Action Plan (EAP) is currently hindered by a critical funding gap of nearly US$1 billion through 2013.

The Global Emergency Action Plan

Intensified focus on worst-performing areas of Nigeria, Pakistan and Afghanistan to increase vaccination coverage by end of 2012 to levels needed to stop transmission;
New approaches tailored to each country to tackle persistent challenges and improve polio vaccination campaign performance;
Heightened accountability, coordination and oversight to ensure success at every level of government and within every partner agency and organization.
Surge of technical assistance and social mobilization capacity.

Working in emergency mode

Notes for editors:

Links to:

Global Emergency Action Plan (EAP) 2012-2013
Country fact sheets: Nigeria, Pakistan, Afghanistan
Funding gap
Infographic
B-roll

SOURCE Global Polio Eradication Initiative (GPEI)

Drug Ads Often Gloss Over Side Effects, Enlist Doctor Endorsements

Wed, 23 May 2012 07:12:32 +0000

Drug company advertising often downplays side effects. This misleading information can lead to patient injury.

May 23, 2012 /24-7PressRelease/ -- Prescription drug advertisements have become ubiquitous in United States' media, including television and magazines. Unfortunately, these ads may be ultimately misleading about potential side effects, placing patients at risk.

How Drug Marketing Campaigns Portray Side Effects

Drug companies use several techniques to downplay the side effects of the potentially dangerous drugs they are advertising.

First, a drug company may enlist a celebrity to endorse its product. For example, the anti-inflammatory drug Enbrel is promoted by professional golfer Phil Mikelson. In these types of advertisements, the side effects of the drugs are disclosed in a quickly delivered voiceover toward the end of the commercial. Other drug advertisements, like those for Celebrex, place a lot of emphasis on the benefits of the drug while downplaying serious side effects like heart attack or stroke.

Another common technique is enlisting the endorsement of an actual physician, who may agree to recommend drugs in exchange for board membership, lectureship and even consulting fees.

Doctors' Drug Endorsements Affect Patient Care

When doctors endorse a drug for money or other personal benefits, however, the exchange can affect the type of care patients receive. An investigation by the New York Times found that a quarter of all doctors accept cash for their endorsement of prescription drugs and a whopping two-thirds accept other compensation, like meals or speaking engagements, for endorsements.

Unfortunately, this type of relationship between physicians and drug companies can affect the medical decisions of the endorsing physicians. Physicians who endorse a certain medication are more likely to prescribe those medications when an alternative treatment would be more medically appropriate. In some instances, the New York Times found that physicians in this situation were more apt to prescribe antipsychotic drugs to children, for whom the drugs are not approved.

Obama's Health Care Law to Provide More Transparency

Fortunately, there are provisions in the new health care bill which will make the relationships between physicians and drug companies more transparent to the public. The law requires drug companies which pay doctors for endorsements for any drug or medical device covered by Medicare or Medicaid to report the relationships to the government. The Obama administration estimates that the law will affect over one thousand drug companies.

When drug companies downplay serious side effects which could cause injury, it leaves them vulnerable to lawsuits claiming they were negligent in their duty to warn against potential side effects. It may also be possible for injured patients to sue if a product is found to be defective. If you have been injured by one of your prescription drugs and feel you did not receive a clear explanation of the drug's potent side effects, please consult an experienced personal injury attorney to explore your legal options.

Article provided by Thomas Q. Keefe, Jr., P.C.

Visit us at http://www.tqkeefe.com/

---

Press release service and press release distribution provided by http://www.24-7pressrelease.com

Global Human Vaccines Industry

Wed, 16 May 2012 10:02:37 +0000

Global Human Vaccines Industry

PR Newswire

NEW YORK, May 16, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Human Vaccines Industry

http://www.reportlinker.com/p092575/Global-Human-Vaccines-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_

This report analyzes the worldwide markets for Prophylatic Human Vaccines in US$ Million by the following Product Segments: Pediatric Prophylactic Vaccines and Adult Prophylactic Vaccines. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East and Latin America. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report also analyzes the world market for Therapeutic Vaccines for the period 2010 to 2015. The report profiles 162 companies including many key and niche players such as ALK - Abello A/S, Bavarian Nordic A/S, Crucell N.V., CSL Ltd., GlaxoSmithKline PLC, GlaxoSmithKline Biologicals S.A, Medimmune, Inc., Merck & Company, Inc., Novartis Vaccines & Diagnostics, Inc., Sanofi, Sanofi-Pasteur SA, Sanofi Pasteur, Inc., Shanta Biotechnics Ltd., Vaxin, Inc., and Wyeth. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting Limitations I-1Disclaimers I-2Data Interpretation & Reporting Level I-3Quantitative Techniques & Analytics I-3Product Definitions and Scope of Study I-3Prophylactic Vaccines I-3Therapeutic Vaccines I-4

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW & OUTLOOK II-1Human Vaccines Market Remains Resilient to Recession II-1Global Human Vaccines Market: A Snapshot II-1Market Dynamics II-2Vaccine Pricing: The Developed - Developing Divide II-2Growth Drivers in a Capsule II-3Developed World: The Key Markets II-3Looking Ahead II-3Emerging Markets: The Future Growth Area II-4Competitive Scenario II-5World's Leading Producers II-5Table 1: Leading Players in the Worldwide Vaccines Market(2008): Market Share Breakdown by Value Sales forGlaxoSmithKline, Sanofi-Aventis, Merck & Co., Novartis,Wyeth, and Others (includes corresponding Graph/Chart) II-6ALK- The Global Leader in Allergy Vaccines II-6Table 2: Leading Players in the Worldwide Allergy VaccinesMarket (2005 & 2006 - A Historic Perspective): Market ShareBreakdown of Value Sales (*) for ALK- Abello, Stallergenes,Allergopharma, and Others (includes correspondingGraph/Chart) II-7

2. PRODUCT OVERVIEW II-8

Introduction to the Concept of Immunity II-8

Role of Vaccines in Strengthening the Immune System II-8

Vaccines and Immunotherapy II-9

Historical Overview of Vaccines II-9

How it Began II-9

So Far So Good II-11

Successful Vaccine Introductions in the Past II-11

Contribution of Animal Research to Vaccine Production II-11

Types of Vaccines II-12

Live, Attenuated Vaccines II-13

Combination Vaccines II-14

Killed or Inactivated Vaccines II-14

DNA & Recombinant DNA Vaccines II-15

Toxoids II-15

Cellular Fractions II-15

Conjugate Vaccines II-15

Subunit Vaccines II-16

Passive Immunization II-16

Prophylactic Vaccines II-16

Prevention Better than Cure II-16

Prophylactic Pediatric Vaccines II-17

Vaccination Over the Years II-17

A Mature Market II-17

Challenges for Pediatric Vaccines Market II-18

BCG Vaccine II-18

Growth Boosting Factors for TB Vaccines II-19

Demand Restraining Factors for TB Vaccines II-19

Major Issues to be Addressed in the TB Vaccine Market II-19

Table 3: Global Historic Review for TB Vaccines Market:

Annual Sales for Years 2000 through 2005 (In US$ Million)

(includes corresponding Graph/Chart) II-20

Hemophilus Influenza Type B Vaccine II-20

Hib and Combination Vaccines by Producer II-20

Table 4: Historic Review for Pediatric Haemophilis

Influenza B Vaccine Market in the US and Europe: Annual

Sales for 2000-2005 (In US$ Million) (includes

corresponding Graph/Chart) II-21

Table 5: Historic Review for Pediatric HaemophilisInfluenza B Vaccine Market in the US: Annual Sales for2000-2005 (In Million Doses) (includes correspondingGraph/Chart) II-21Diphtheria/Tetanus/Pertussis Vaccines II-22DTP, DTaP, and Combination Vaccines Offered by MajorProducers in US II-22Table 6: Leading Players in the US DTP and DTaP VaccinesMarket (2003-2005 - A Historic Review): Market ShareBreakdown of Value Sales for Sanofi Pasteur, Wyeth,GlaxoSmithkline, and others (includes correspondingGraph/Chart) II-23

Table 7: Historic Review of DTP and DTaP Vaccines Market in

the US: Annual Sales for 2000- 2005 (In US$ Million)

(includes corresponding Graph/Chart) II-23

Table 8: Historic Review of DTP Vaccine Market in Europe:Annual Sales for 2000-2005 (In US$ Million) (includescorresponding Graph/Chart) II-24Hepatitis A Vaccine II-24Hepatitis B Vaccine II-24Hepatitis B Epidemiology II-25Table 9: World Market for Hepatitis B Vaccines: AnnualSales for Years 2009 through 2017 (In US $ Million)(includes corresponding Graph/Chart) II-25

Table 10: Historic Review for Hepatitis B Vaccines Market

in US and Europe: Annual Sales for 2000-2005 (In US$

Million) (includes corresponding Graph/Chart) II-26

Measles/Mumps/Rubella Vaccines II-26

Table 11: Historic Review for Measles-Mumps- Rubella (MMR)

Vaccine Market in US and Europe: Annual Sales for 2000-2005

(In US$ Million) (includes corresponding Graph/Chart) II-27

Table 12: Historic Review for Measles-Mumps-Rubella (MMR)Vaccine Market in the US: Annual Sales for 2000-2005 (InMillions of Doses) (includes corresponding Graph/Chart) II-27Rotavirus Vaccines II-28Polio Vaccines II-28Table 13: Historic Review for Polio Vaccines Market inEurope: Annual Sales for 2000-2005 (In US$ Million)(includes corresponding Graph/Chart) II-28

Table 14: Historic Review for Polio Vaccines Market in the

US: Annual Sales for 2000-2005 (In US$ Million) (includes

corresponding Graph/Chart) II-29

Table 15: Historic Review for Polio Vaccine Market for BothVaccine Types in the US: Annual Sales for 2000-2005 (InMillion Doses) (includes corresponding Graph/Chart) II-29

Table 16: Historic Review for Polio Vaccine Market for Both

Vaccine Types (OPV and IPV) in the US in Percent of Doses

from 2000-2005 II-30

Varicella Vaccine II-30

Table 17: Historic Review for Varicella Vaccine Market in

the US and Europe: Annual Sales for 2000- 2005 (In US$

Million) (includes corresponding Graph/Chart) II-31

Table 18: Historic Review for Varicella Vaccines Market inthe US: Annual Sales for 2000-2005 (In Million Doses)(includes corresponding Graph/Chart) II-31Need for Combination Vaccines II-32Prophylactic Adult Vaccines II-32Favorable Market Growth II-32Hepatitis A Vaccine II-33Hepatitis B Vaccines II-34Key Issues Affecting the Adult Hepatitis Vaccines Market II-35Cholera Vaccine II-35Hepatitis A/Hepatitis B Vaccine II-35Japanese Encephalitis Vaccines II-35Influenza Vaccines II-36Table 19: Global Flu Vaccines Market by Region (2005):Percentage Share Breakdown of Value Sales for the US, EU,and Rest of the World (includes corresponding Graph/Chart) II-37

Table 20: Global Flu Vaccines Market by Leading Players

(2005): Market Share Breakdown by Volume Sales for Sanofi

Pasteur, Chiron, GSK and Others (includes corresponding

Graph/Chart) II-37

Table 21: Rate of Influenza Vaccine Consumption Among TargetGroups (includes corresponding Graph/Chart) II-37

Table 22: Global Historic Review for Adult Influenza

Vaccines: Annual Sales for 2000-2005 (In US$ Million)

(includes corresponding Graph/Chart) II-38

Growth Boosting Factors for Influenza Vaccines Market II-38

Key Issues Affecting Influenza Vaccines Market II-38

Age-Driven Strategies Drive Target Market for Influenza

Vaccines II-39

Healthcare Professionals Increase Target Market for

Influenza Vaccines II-39

Lyme Disease Vaccine II-39

Pneumococcal Disease Vaccines II-39

Meningococcal Vaccines II-40

Rabies Vaccines II-40

Table 23: Global Historic Review for Rabies Vaccines: Annual

Sales for 2000-2005 (In US$ Million) (includes

corresponding Graph/Chart) II-41

Typhoid Vaccine II-42

Yellow Fever Vaccine II-42

Need for Additional Vaccines II-42

Therapeutic Vaccines II-44

DNA Holds the Key II-44

Huge Potential for Protein Based Vaccines II-44

Therapeutic Hepatitis Vaccines II-44

Therapeutic Addiction Vaccines II-45

Cancer Vaccines II-45

Human Papillomavirus (HPV) Vaccine II-45

Breakthroughs in Cancer Vaccine Market II-45

Factors Affecting the Market for Cancer Vaccines II-46

Vaccine for AIDS II-46

What is AIDS? II-46

Global Statistics II-47

Table 24: Worldwide HIV/AIDS - 2007 (includes corresponding

Graph/Chart) II-47

Table 25: Worldwide HIV & AIDS Incidences (2007): ARegional Breakdown for Living and Newly Infected Cases(includes corresponding Graph/Chart) II-48

Table 26: Worldwide HIV & AIDS Prevalence Rate in Adults

Aged between 15 and 49 Years for the Year 2007 (includes

corresponding Graph/Chart) II-49

Asia-Pacific II-49

Central Asia & Eastern Europe II-50

Commonwealth of Independent States (CIS) II-50

Latin America (Including the Caribbean Islands) II-50

Sub Saharan Africa II-50

North Africa & the Middle East II-51

Developed Regions and High-Income Countries II-51

United States II-51

Table 27: New HIV Infection Cases among Men in the US

(2006): Percentage Breakdown by Mode of Infection

(includes corresponding Graph/Chart) II-51

Table 28: New HIV Infection Cases in the US (2006):Percentage Breakdown by Racial/Ethnic Groups (includescorresponding Graph/Chart) II-52

Table 29: New HIV Infection Cases among Women in the US

(2006): Percentage Breakdown by Mode of Infection

(includes corresponding Graph/Chart) II-52

Development of Treatment Options II-52

Categories of Vaccines for AIDS II-53

HIV Vaccines Under Development II-53

HIV Vaccines (Prophylactic/Therapeutic) Under Development:

As of 2010 II-53

Malaria Vaccine II-54

Therapeutic Vaccines Against Infectious Diseases: The

Challenges II-54

Melanoma: Prospects for Treatment II-54

Melanoma Vaccines under Development: As of 2010 II-54

Autoimmune Diseases II-55

How Do Autoimmune Diseases Occur II-55

Types of Autoimmune Diseases II-55

Need for Developing Autoimmune Therapeutic Vaccines II-55

Travel Vaccines: Opportunities II-55

SARS - A Review II-55

Vaccinations Recommended for Travel to High-Risk Areas II-56

Mechanisms for Vaccine Delivery II-57

Edible Vaccines II-57

Oral Vaccines II-59

Tablet Based Vaccines II-59

Mucosal Delivery II-59

Transdermal Patch Delivery II-59

3. MARKET TRENDS & ISSUES II-60Newer Vaccines in Pipeline to Cheer Up Pharma Companies II-60Select Vaccines Currently in Phase III Clinical Trials II-60Threat of Pandemic Rejuvenates Vaccine Market II-60Influenza Vaccines On a Growing Spree II-61H1N1 Vaccines Hit the Market in August 2009 II-61H1N1 Influenza Vaccines and Manufacturers II-62Influenza Market Faces Several Challenges II-63Economic Factors Hamper Optimal Vaccine Development and Delivery II-63Increasing Need for Vaccine Promotion in the Developing Regions II-63Changing Vaccine Needs II-63DNA Vaccines: Engineering Growth II-64AIDS Vaccine: Long Road Ahead II-65HIV Vaccines Research Clipped by Lack of Funds II-66Funding Drops In HIV Vaccine Research Amid Recession II-66Noninjectable Vaccines: Gain Without Pain II-66Need for a Human Vaccine for Leishmaniasis II-66Conjugate Vaccines: A Technological Innovation II-67Need For a New TB Vaccine II-67Table 30: Worldwide Prevalence of TB Cases (in '000s) byRegion for the Year (2007) (includes correspondingGraph/Chart) II-67Companies Involved in TB Vaccine Research: As of 2010 II-68Religious Concerns Over Immunizing Young Girls Against HumanPapillomavirus II-68Changing Travel Patterns Increase Demand for Hepatitis B Vaccine II-68DTaP Vaccines Approved for Booster Vaccination II-69Advances in Biotechnology Spearheading Vaccines' Growth II-69BioWarfare: Threat Perception and Preparedness II-69Overview of Potential Bio-Terrorist Agents II-70Smallpox (Variola Major) II-70Anthrax (Bacillus Anthracis) II-70Plague (Yersinia Pestis) II-70Botulism (Clostridium Botulinum) II-71Tularemia (Francisella Tularensis) II-71Market Concerns II-71Safety Factor II-71Development Delays II-72Storage Problems II-72Perfluorocarbons as Alternative to Overcome Storage Problems II-72Costs II-72Standards for Vaccine Safety and Quality II-72

4. DISTRIBUTION CHANNELS II-73

5. TECHNOLOGICAL DEVELOPMENTS II-74Applying Gene Therapy to Develop Therapeutic Solutions II-74Research and Trials of AIDS Vaccines II-74Ongoing Clinical Testing for AIDS Vaccines: Status As of 2010 II-74International AIDS Vaccine Initiative (IAVI) II-75Cancer II-75Cancer Type and Area Effected II-75Immunotherapies for Cancer II-75Cancer Treatment Drugs II-76Issues Effecting the Development of Commercially ViableCancer Vaccines II-76Frequency of Vaccination II-77Growth Boosters in the Cancer Vaccines Market II-77Available Cancer Treatment Vaccines II-78Select Cancer Vaccines (Therapeutic and Prophylactic) inClinical Trials: As of 2010 II-78Other Cancer Treatment Vaccines II-79Application of Botulinum Toxin as Delivery Mechanism for OralVaccines II-79

6. CLINICAL TRIALS IN THE VACCINES MARKET II-80

Vaccinogen Selects Clinipace for Phase 3b Clinical Trial with

OncoVAX II-80

BioSante to Restart Prostate Cancer Vaccine Clinical Testing II-80

University of Oxford to Commence Phase 2b Proof-of- Concept

Clinical Trials with TB Vaccine in Infants II-80

Emergent Begins Phase I/II Clinical Studies of AIG for

Anthrax Treatment II-81

7. RESEARCH BREAKTHROUGHS - A HISTORIC PERSPECTIVE BUILDER II-82Favrille Announces Phase III Registration Trial Results ofSpecifid in Patients with Follicular B-Cell Non-Hodgkin'sLymphoma II-82Novartis Announces Phase III Results of Menveo® Vaccine II-82Emergent Commences Phase II Clinical Study of Typhoid Vaccine II-82AVANT's Single-Dose Oral Ty800 Vaccine Meets Key Endpoints II-83Emergent BioSolutions' Typhoid Vaccine Completes Final PhaseII Clinical Trial II-83Antigenics Announces Positive Data on Phase-I Study of ACAM-FLU-ATM Vaccine II-83Bavarian Nordic's IMVAMUNE® Post-Exposure VaccinationDemonstrates Protection Against Fatal Poxvirus Infection II-84BSU Scientists to Commence Human West Nile VaccineDevelopment Project II-84Intercell Concludes First Phase Clinical Studies of IC31®Adjuvanted Influenza Vaccine II-84Protherics Commences Phase 2 Angiotensin Vaccine Study II-85Novartis Receives European Approval for Optaflu® Flu Vaccine II-85CSL Biotherapies Files BLA for Influenza Vaccine II-85Orchestra Therapeutics Abandons Development of HIV Vaccine II-86AlphaVax Concludes Phase I Clinical Trial of Flu Vaccine II-86AVANT Presents Preclinical Data on Enteric Vaccine II-87Baxter Declares Results of Seasonal Flu Vaccine Candidate Trial II-87IDM Pharma Announces Interim Data of Phase II Clinical Trialsof Lung Cancer Vaccine II-87Novavax Announces Developments in Discovery Program II-88Acambis Pioneers Testing of West Nile Virus Vaccine in Grown Ups II-88Acambis Initiates Test of single-dose JE vaccine in India II-89AVAX Technologies Initiates Phase 3 Clinical Trial For M-Vax II-89LigoCyte Pharmaceuticals Begins Clinical Testing of NorovirusVaccine II-89Alphavax Initiates Clinical Testing for Flu and CMV Vaccines II-89Sanofi Pasteur Begins Phase 2 Testing of New Influenza Vaccine II-90Antigenics Reveals the Preliminary Data of Clinical Trial ofOncophage® II-90Baxter Reveals Phase I/II Clinical Trial Results of H5N1Pandemic Vaccine II-91Crucell and AERAS Initiates Tuberculosis Vaccine Clinical Trial II-91DOR BioPharma Announces Phase I Results of RiVax™ II-91GlaxoSmithKline Starts Clinical Trials to Test H5N1 PandemicFlu Vaccines II-91MedImmune Initiates Phase I Clinical Trial of Avian H5N1 Vaccine II-91MedImmune Reveals Results of Phase 3 Study for CAIV-T II-92MedImmune Initiates Second Phase 1 Study with MEDI-534 II-92Sanofi Pasteur Initiates First Clinical Trial of Cell BasedH7N1 Vaccine II-92Therion Biologics Completes Enrollment for Phase III trialsof PANVAC-VF II-92ViRexx Finishes the Treatment in Phase I Study of Hepa Vaxx BVaccine II-93Antigenics Begins Phase I Clinical Trial of AG-707 II-93Positive Results in Novavax's Pandemic Influenza Vaccine Pre-clinical Trials II-93Trials Reveal H5N1 Pre-Pandemic Vaccine of Sanofi PasteurEffective II-93PowderMed Reveals Results for Phase 1 Trials for InfluenzaVaccine II-93Phase II clinical trials of China's hepatitis B vaccine II-93Findings Prove New Nose-Spray Vaccines Effective II-94Large Doses of H5N1 Influenza Vaccine Appears Effective II-94New Vaccine Technology to Prevent TB II-94HPV Vaccine to Help Prevent Cervical Cancer II-94Scientists Develop H7N1 Avian Influenza Vaccine II-94Human H5N1 Vaccine Developed by Central Hygiene andEpidemiology Institute II-95

8. PRODUCT DEVELOPMENT/LAUNCHES II-96

Vivalis and SAFC Launch Ex-Cell EBx Media II-96

9. PRODUCT DEVELOPMENT/LAUNCHES - A HISTORIC PERSPECTIVE BUILDER II-97MSD Pharmaceuticals India Launches GARDASIL Vaccine II-97Sanofi-Aventis Introduces ActHIB Vaccine in Japan II-97Sinovac Biotech Introduces Anflu® II-97Nventa Biopharmaceuticals Develops Poly IC-Poly Arginine II-97Replikins Develops New Synthesized Vaccine II-98GlaxoSmithKline Biologicals Launches Cervarix II-98CSL Develops New Vaccine for Prevention of Bird Flu II-98GlaxoSmithKline to Introduce Five Key Medicines for Oncology II-98FFF Enterprises Unveils My Flu Vaccine Network II-98Nabi Biopharmaceuticals to Develop NicVax Vaccine forReducing Nicotine Effects II-99GenPhar Develops Highly Effective Tetravalent Dengue Vaccine II-99Iomai Commences the Development of Prophylactic Traveler™sDiarrhea Vaccine II-99Biological Immunological to Produce and Sell r-Hepatitis BVaccine II-99Thailand Researchers Commence the Development of Human BirdFlu Vaccine II-99USV to Commercialize Typhoid Vaccine II-100ALK-Abello Introduces GRAZAX® Anti-Allergy Vaccine II-100Novartis Unveils Influenza Virus Vaccine Fluvirin® II-100Wyeth Introduces Latest 7-in-1 Pneumococcal Conjugate Vaccine II-100Intervet Releases Arnhem, a Prototype of Avian Influenza Vaccine II-100Shantha Launches 'Jencevac' Brain Fever Vaccine II-101Wockhardt and Zhejiang Introduces New Hepatitis- A Vaccine II-101GSK Introduces Rotarix(R) Vaccines for Infants II-101Sinovac Biotech Introduces Bilive™ II-101

10. RECENT INDUSTRY ACTIVITY II-102

'Sanofi-Aventis' Name Turns Simpler, Now Known as Just 'Sanofi' II-102

Antigenics Changes Name to Agenus, Provides Pipeline Details II-102

AltraVax Acquires Vaccine Development Technology Package from

Maxygen II-102

Pfizer Integrates R&D operations of Wyeth II-103

Dendreon Receives FDA Approval for PROVENGE® Vaccine to Treat

Men with Advanced Prostate Cancer II-103

SVA and Parenteral Biotech Enter into a Partnership to

Distribute and Supply Vaccines II-103

Novartis Obtains FDA Approval for MenveoA® Vaccine II-103

Pfizer to Supply Vaccine for Pneumococcal Disease II-104

Torii Enters into Partnership with Riken II-104

Sanofi-Aventis Acquires Shantha Biotechnics II-104

Affitech AS Merges with Pharmexa A/S II-104

Takeda Acquires IDM Pharma II-105

Pfizer Concludes Wyeth's Acquisition II-105

Sanofi Pasteur and Syntiron Sign Agreement to Develop and

Market Prophylactic Vaccine II-105

Cell Genesys Merges with BioSante Pharmaceuticals II-105

Simcere Pharmaceutical Acquires Controlling Stake in ChinaVax II-106

Novartis to Acquire 85% Stake in Zhejiang Tianyuan II-106

FDA Approves Merck's Gardasil for Males under 9 to 26 Years Age II-106

Merck Sign Agreement with CSL Biotherapies II-106

Sinovac Forms JV with Dalian to Develop and Market Human-Use

Vaccines II-106

CPL Enters Into JV with Novavax II-107

Nobilon Ties-up with WHO II-107

GeoVax Labs to Relocate Operations II-107

SingVax and Inviragen Merge II-107

Sanofi-aventis and Mexican Authorities Enter into Agreement II-108

Kitasato Institute and Daiichi Sankyo Ink Agreement II-108

ACVD to Enter into Alliance with Emory Vaccine Center II-108

Emory University to Set Up Emory Institute for Drug Discovery II-108

ImmunoVaccine Technologies Enters into Partnership with FIT

Biotech II-108

VGX Pharmaceuticals Merges with Inovio Biomedical II-109

Sanofi Pasteur Obtains EC Approval for INTANZA®/IDflu® II-109

European Commission Grants Marketing Authorization to Ixiaro®

Vaccine II-109

US FDA Approves Ixiaro® Vaccine II-109

Emergent BioSolutions Purchases Protein Sciences II-109

Vaccine Technologies Signs Agreement with Celldex Therapeutics II-110

Oxford-Emergent Tuberculosis Consortium and ProBio Gen Ink

Agreement II-110

JN-International to Acquire Biocor's Vaccine Research and

Manufacturing Plant II-110

Mymetics to Acquire Bestewil Holding BV II-111

Eureka Genomics and Nanobac Pharmaceuticals to Merge II-111

Immunovaccine Enters into Agreement with National Cancer

Institute II-111

GSK Forms Joint Venture with Walvax II-111

11. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVEBUILDER II-112AVANT Adopts New Identity as Celldex Therapeutics II-112Eli Lilly Takes Over ImClone Systems II-112Sanofi Pasteur Acquires Acambis II-112Novartis to Acquire Protez II-112Novartis Inks Agreement with AlphaVax II-113Vacsera Signs Agreement with Omninvest II-113GeoVax Sign LOI with Vivalis II-113GlaxoSmithKline Receives EC Approval for Prepandrix Vaccine II-114ShigaMedix SAS and Avesthagen Sign Agreement II-114Shenzhen Neptunus Inks Agreement with Glaxo SmithKline II-114Sanofi Pasteur Establishes Vaccine Manufacturing Facility II-114Emergent BioSolutions Forges Joint Venture with theUniversity of Oxford II-114Crucell Bags Contract from NIAID and NIH II-115PharmAthene Takes Over Business of Avecia II-115Crucell and Wyeth Pharmaceuticals Sign Agreement II-115Cytos Biotechnology and Pfizer Vaccines Sign Agreement II-115Intercell Acquires Iomai II-116Emergent BioSolutions to Acquire Recombinant Flu Vaccine,FluBlok® II-116Encorium Group Signs Contract with Protherics II-116Beijing Keyuan Xinhai Pharmaceutical Signs Agreement withChina Biopharma II-117Callisto Merges with Celldex II-117Mymetics Corp. Buys Preventive Malaria Vaccine of PevionBiotech AG II-117Dynavax Inks Agreement with Novartis II-117NasVax to Buy Protea Vaccine Technologies II-118Paladin Labs Buys ViRexx Medical Corp II-118Emergent BioSolutions Acquires Group of Anthrax MonoclonalAntibodies from AVANIR II-118China Biopharma and BKXPC Enter into Agreement II-119Encorium Signs Contract with Protherics for Phase 2 Trial ofATV for Hypertension II-119GenPhar to Establish Vaccine Production Plant in South Carolina II-119Intercell Partners SSI and Sanofi Pasteur to Further DevelopTB Vaccine II-119Intercell and PATH Malaria Vaccine Initiative Form NewPartnership for Malaria Vaccine II-120Intercell Receives Manufacturer's License for Production ofJE Vaccine II-120GSK Receives US FDA Approval for ROTARIX® Rotavirus Vaccine II-120Dynavax and Merck & Co Announce Clinical Hold of HEPLISAVVaccine Trial II-121Pharmexa and Ichor Enter into Co-Development Agreement forMultiple DNA Vaccines II-121Crucell Enters into Exclusive Development Agreement withWyeth Pharmaceuticals II-122Crucell and Sanofi Ink an Agreement for Advanced Anti-RabiesBiologicals II-122FDA Confers Priority Designation for Supplemental Applicationfor GARDASIL ® II-123Sanofi Submits a European Marketing Approval Application forFirst Influenza Vaccine II-123Lonza Consolidates Micobial Biopharma Operations II-123Novartis Acquires Rights Over a Novel Therapeutic VaccineCandidate II-124AstraZeneca Purchases MedImmune II-124Nobilon Purchases EBx™ Cell Lines Rights from Vivalis II-124NasVax Inks Partnership Agreement with SciGen II-124GSK Inks Co-Promotion Agreement with Sinovac Biotech for Anflu II-125Pfizer Buys Coley Pharmaceutical Group II-125FDA Selects sanofi's H5N1 Vaccine II-125Novartis Starts Construction of a Cell-Culture Based VaccineProduction Facility II-125IVT Signs an MoU to Take Over Immunotope II-125Oxford BioMedica Takes Over Oxxon Therapeutics II-126DND Issues RFP for acquisition of MVA-based smallpox vaccine II-126GlaxoSmithKline Acquires Reliant Pharmaceuticals II-126GSK Acquires Praecis Pharmaceuticals II-127Berna Biotech Divests Stake in Pevion Biotech II-127GeoVax Signs a Private Placement Agreement with Pure Capital II-127Crucell Inks a Research License Agreement with ISU ABXIS ofKorea II-127China Biopharma Concludes Capital Funding to ZT Biotech II-127Crucell and Acambis Ink a Licensing Agreement for PER. C6 ®Technology II-128Novartis and Intercell Join Hands to Advance Vaccine Programs II-128Serum Institute and Akorn Ink MoU for VaccineCommercialization in US Market II-128Merck Plans to Establish a Human Vaccine Facility in Ireland II-129Schering-Plough Acquires Organon Bio Sciences II-129Intas Biopharmaceuticals Enters into Collaboration Agreementwith Virionics II-129Oxxon Therapeutics Starts U.S. Operation II-130GenPhar and ImmuneRegen Enter into Research Partnership II-130Intercell Submits BLA for JE Vaccine to US FDA II-130AVANT and Select Vaccines Enter into R&D Partnership II-130AVAX Enters into Agreement with Cancer Treatment Centers ofAmerica II-131CSC's DVC and Baxter Receive Contract Modification from U.S. HHS II-131DOR BioPharma Enters into CRADA with Walter Reed Army Institute II-132Dynavax and Merck to Enter into Partnership to DevelopHepatitis B Vaccine II-132Emergent BioSolutions Commences Delivery of Bio Thrax® to USHealth Department II-133Maxygen and Sanofi Pasteur sign License Agreement II-133Beijing Public Health Bureau Enters into Purchase Agreementwith Sinovac II-134Novartis Wins US Government Contract for Developing AntigenTechnology II-134MedImmune Announces Licensing of Reverse Genetics Technologyto GlaxoSmithKline II-135MedImmune Wins US Government Contract II-135MedImmune and Human Genome Sciences Sign Lease Agreement II-135Acambis Announces Signing of Collaboration Agreement withSanofi Pasteur II-136Acambis Announces JE Partnership Agreement with Sanofi Pasteur II-136Crucell Procures Major Patent for Influenza Vaccine Production II-136CSL Receives FDA Approval for Influenza Virus Vaccine II-136GlaxoSmithKline Inks Contract with UK Government II-137Merck & Co., Inc. and Dynavax to Jointly Develop Hepatitis BVaccine II-137Sanofi Pasteur Wins Contract to Design, Retrofit and MaintainInfluenza Vaccine Unit II-138Sanofi Pasteur Completes Construction of Influenza VaccineProduction Unit II-138Amgen Acquires Abgenix II-138Pfizer Acquires PowderMed II-139CancerVax and Micromet Merge to Establish Micromet, Inc. II-139Novartis Acquires Chiron II-139Dynavax Takes Over Rhein Biotech II-139AnGes and Vical Ink Collaborative Agreement II-139GeoVax Merges with Dauphin II-139Hawaii Biotech and Avantogen Merge to Form New Entity II-140CytoDyn Acquires Advanced Influenza Technologies II-140Emergent BioSolutions Acquires VIVACS II-140Acambis Divests Berna Business to Crucell II-140Novavax Inks an Agreement with Bharat Biotech to DevelopAvian Flu Vaccine II-140Aeras Receives License for Developing and DistributingTuberculosis Vaccine II-140Acambis to Supply Smallpox Vaccine to CDCP II-141AlphaVax and Wyeth Enhance Existing Licensing Agreement II-141Baxter Enters into a Contract to Supply Pandemic InfluenzaVaccine II-141Sanofi Pasteur Signs Stockpile Contract with the US Government II-141Crucell Licenses PER.C6® Technology to ADImmune Corporation II-142Baxter Wins Stockpile Production Contract for H5N1 from the NHS II-142Crucell Earns NIH Contract to Develop HIV Vaccine II-142Novartis Secures Stockpile Supply Contract from the USGovernment II-142Novartis Signs Distribution Agreement with Intercell II-142GSK Receives Stockpile Supply Contract for Fly Pandemic fromthe HHS II-143GSK Signs H5N1 Antigen Influenza Vaccine Contract withSwitzerland II-143DOR BioPharma Forms Alliance to Develop Ricin Vaccine II-143Nobilon and NVI to Jointly Develop RSV Vaccine II-144SciGen and OctoPlus Join Forces to Develop Hepatitis BVaccine Delivery II-144AlphaVax Receives Patent for Alphavaccines Manufacturing Process II-144IVI Receives Funds for Cholera Vaccine Development Program II-144Novavax Forms Strategic Alliance with US-based, PacificGMP II-144Sanofi Pasteur Enters into Partnership with PDVI II-145MedImmune Inks a Cooperative R&D Agreement with NIAID II-145MedImmune Bags a Five-Year HHS Contract II-145Novavax Enters into a Cooperative Research Agreement with CDC II-146GlaxoSmithKline Establishes New Vaccine Manufacturing Facility II-146GenPhar Extends R&D Contract with NMRC II-146Medlmmune Files for INDA with FDA for a New Influenza Vaccine II-146Rotarix™ Vaccines Receives European Approval II-147Merck's GARDASIL® Receives FDA Approval II-147CDC Adds Merck's GARDASIL® Under its VFC Category in the US II-147Medlmmune Submits sBLA to the FDA Refrigerator-StableInfluenza Vaccine II-147Medlmmune Submits sBLA to the FDA for Expanded Label for CAIV-T II-148Medlmmune Receives FDA Approval for the Use of ReverseGenetics Technology II-148Vivalis Starts a New Plant in France to Produce Viral Vaccines II-148Fiocruz Provides Yellow-Fever Vaccine to Peruvian Government II-148Merck Receives FDA Approval for Zostavax Vaccine II-148The US Health and Human Services Department Awards Grant toPharma Companies II-148GlaxoSmithKline Expands License and Supply Agreement withAntigenics II-149GlaxoSmithKline Applies for Approval for Cervical Cancer Vaccine II-149Omnia Biologics Signs Deal with Aeras Global TB VaccineFoundation II-149Aeras Alliances with Dutch Scientific Organizations toDevelop Latest TB Vaccines II-149Embrex, Shenzhen, and P.R. China Team Up for ManufacturingInfluenza Vaccine II-150Health Canada Grants Approval to Merck's RotaTeq II-150HepaLife Technologies Receives License for Technology from MSU II-150Hindustan Latex Ties-up with Bharat Biotech for MarketingVaccines II-150Emergent BioSolutions and Sanofi Pasteur Sign Agreement II-150USV and BCIL Enter into Agreement II-151GenVec Receives Fifth-Year Extension of Contract from NIAID II-151Inovio Joins Hands with Tripep to Develop Hepatitis C Vaccine II-151Novavax and Bharat Biotech Form Alliance to Develop PandemicFlu Vaccine II-151Panacea Biotech Joins Hands with NVI to Create Polio Vaccine II-151Immune Response Ties Up with Accelsiors for Trial of NeuroVaxVaccine II-152Nordic Vaccine Joins Forces with Ace BioSciences to DevelopEfficient Vaccines II-152Eisai Partners with DNAVEC to Develop New Vaccine II-152ViRexx Partners with DRDC to Develop Biodefence Vaccines II-152Biovirx Teams Up with IDT to Reintroduce Vaccine for Infants II-153LG Life Sciences Enters into Agreement with Sinovac II-153MediGene Awards Licenses to Virionics for CVLP Vaccine Program II-153FluLaval Influenza Vaccine Receives FDA Approval II-153Merck Applies for Approval to Market Gardasil in China II-154Bio-Bridge Establishes New Vaccine Facility in China II-154SIIL Established the First-ever Biotech SEZ in India II-154Aeras Foundation Establishes New Laboratory for TB Vaccine II-154China Biopharma Distributes Flu Vaccine in China II-155ViroPro Founds New Subsidiary for Developing Medicinal Vaccines II-155

12. FOCUS ON SELECT GLOBAL PLAYERS II-156

ALK - Abello A/S (Denmark) II-156

Bavarian Nordic A/S (Denmark) II-156

Crucell N.V. (The Netherlands) II-157

CSL Ltd. (Australia) II-157

GlaxoSmithKline PLC (UK) II-158

GlaxoSmithKline Biologicals S.A (Belgium) II-160

Medimmune, Inc. (USA) II-160

Merck & Company, Inc. (USA) II-160

Novartis Vaccines & Diagnostics, Inc. (USA) II-161

Sanofi (Formerly Sanofi-Aventis SA) (France) II-162

Sanofi Pasteur, SA (France) II-164

Sanofi Pasteur Inc. (USA) II-166

Shantha Biotechnics Ltd. (India) II-166

Vaxin, Inc. (USA) II-167

Wyeth (USA) II-167

13. GLOBAL MARKET PERSPECTIVE II-168Table 31: World Recent Past, Current & Future Analysis forHuman Vaccines (Prophylactic) by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific (excluding Japan), LatinAmerica and Rest of World Markets Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2009 through2017 (includes corresponding Graph/Chart) II-168

Table 32: World Historic Review for Human Vaccines

(Prophylactic) by Geographic Region - US, Canada, Japan,

Europe, Asia-Pacific (excluding Japan), Latin America and Rest

of World Markets Independently Analyzed with Annual Sales

Figures in US$ Million for Years 2003 through 2008 (includes

corresponding Graph/Chart) II-169

Table 33: World 15-Year Perspective for Human Vaccines(Prophylactic) by Geographic Region - Percentage Breakdown ofDollar Sales for US, Canada, Japan, Europe, Asia-Pacific(excluding Japan), Latin America and Rest of World Markets forYears 2003, 2011 & 2017 (includes corresponding Graph/Chart) II-170

Table 34: World Recent Past, Current & Future Analysis for

Human Vaccines (Prophylactic) by Product Segment - Pediatric

and Adult Markets Independently Analyzed with Annual Sales

Figures in US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) II-171

Table 35: World Historic Review for Human Vaccines(Prophylactic) by Product Segment - Pediatric and AdultMarkets Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2003 through 2008 (includescorresponding Graph/Chart) II-172

Table 36: World 15-Year Perspective for Human Vaccines

(Prophylactic) by Product Segment - Percentage Breakdown of

Dollar Sales for Pediatric and Adult Markets for Years 2003,

2011 & 2017 (includes corresponding Graph/Chart) II-173

Table 37: World Recent Past, Current & Future Analysis forPediatric Prophylactic Vaccines by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific (excluding Japan), LatinAmerica and Rest of World Markets Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2009 through2017 (includes corresponding Graph/Chart) II-174

Table 38: World Historic Review for Pediatric Prophylactic

Vaccines by Geographic Region - US, Canada, Japan, Europe,

Asia-Pacific (excluding Japan), Latin America and Rest of

World Markets Independently Analyzed with Annual Sales Figures

in US$ Million for Years 2003 through 2008 (includes

corresponding Graph/Chart) II-175

Table 39: World 15-Year Perspective for Pediatric ProphylacticVaccines by Geographic Region - Percentage Breakdown of DollarSales for US, Canada, Japan, Europe, Asia-Pacific (excludingJapan), Latin America and Rest of World Markets for Years2003, 2011 & 2017 (includes corresponding Graph/Chart) II-176

Table 40: World Recent Past, Current & Future Analysis for

Adult Prophylactic Vaccines by Geographic Region - US, Canada,

Japan, Europe, Asia-Pacific (excluding Japan), Latin America

and Rest of World Markets Independently Analyzed with Annual

Sales Figures in US$ Million for Years 2009 through 2017

(includes corresponding Graph/Chart) II-177

Table 41: World Historic Review for Adult ProphylacticVaccines by Geographic Region - US, Canada, Japan, Europe,Asia-Pacific (excluding Japan), Latin America and Rest ofWorld Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2003 through 2008 (includescorresponding Graph/Chart) II-178

Table 42: World 15-Year Perspective for Adult Prophylactic

Vaccines by Geographic Region - Percentage Breakdown of Dollar

Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding

Japan), Latin America and Rest of World Markets for Years

2003, 2011 & 2017 (includes corresponding Graph/Chart) II-179

Table 43: World Recent Past, Current & Future Analysis forHuman Vaccines (Therapeutic) - Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2009 through2017 (includes corresponding Graph/Chart) II-180III. MARKET

1. THE UNITED STATES III-1

A.Market Analysis III-1

Outlook III-1

Growth Drivers III-1

Market Constraints III-1

Supply Shortages Mar Vaccines Market in Early Part of the

Decade III-2

Pediatric Vaccines Market III-2

Market Focus Shifting From Pediatric Vaccines III-2

Growth Drivers for US Pediatric Vaccines Market III-2

Demand Restraining factors for US Pediatric Vaccines Market III-3

Table 44: US Historic Review for Pediatric Vaccines:

Annual Sales (In Millions of Doses) for Years 2000

through 2005 (includes corresponding Graph/Chart) III-3

Table 45: US Pediatric Vaccines by Type in terms ofPercent of Doses: 2000-2005 (includes correspondingGraph/Chart) III-4'Bright' Outlook for Therapeutic Vaccines III-4Select Cancer Vaccines in Pipeline in the US: As of 2010 III-5Market Share of Key Players in North America III-5Table 46: Leading Players in the North American HumanVaccines Market (2005 - A Recent Past Review): MarketShare Breakdown of Value Sales for Merck, Sanofi-Aventis,Wyeth, Glaxo SmithKline and Others (includescorresponding Graph/Chart) III-5The US Influenza Vaccine Market III-5Table 47: The US Influenza Vaccine Market: Production andDistribution of Influenza Vaccine (In Millions) for thePeriod 2000-2001 to 2007- 2008 (includes correspondingGraph/Chart) III-6US DHHS Allocates US$1 Billion for Developing H1N1 Vaccinein 2009 III-72007-2008 Influenza Vaccine Season III-7Table 48: Influenza Vaccine Producers for the InfluenzaSeason (2007-2008): Market Share Breakdown in ProductionTerms for Sanofi Pasteur, Novartis, GlaxoSmithKline,MedImmune, and CSL (includes corresponding Graph/Chart) III-72005-2006 Influenza Vaccine Season III-7Table 49: Funds Forwarded by HHS for Influenza VaccineProduction (2005-2006) to Key Vaccine Manufacturers (In USDollars) (includes corresponding Graph/Chart III-8Influenza Vaccine Producers for the 2006-2007 InfluenzaSeason III-8Problems Effecting Timely Supply of Influenza Vaccine III-8Table 50: Influenza Vaccines Market in the US (2005 - AHistoric Review): Percentage Breakdown of Value Sales forSanofi Aventis, Chiron , GSK, and Medimmune (includescorresponding Graph/Chart) III-9Key Statistics III-9Table 51: Number of Children (In Millions) Under 5 Yearsof Age in the US: 2000-2005 (includes correspondingGraph/Chart) III-9Vaccines and Intended User Group III-10Need for Immunization Schedule for Adults III-10Adult Population: To Drive Future Growth of PertussisVaccines Market III-11Table 52: Pertussis Cases (In Millions) for Years 2000through 2008 (includes corresponding Graph/Chart) III-11Federal Research & Grants III-11National Cancer Institute III-11National Institutes of Health (NIH) III-11NIH Scientists Showcase Potential West Nile Virus Vaccine III-12NIH Doles Out Grants to Biotech Companies III-12Development Funds for HIV Vaccines- Recent Past Data III-12Development Funds for Biodefense-Related Vaccines-RecentPast Data III-12The National Institute of Allergy and Infectious Diseases(NIAID) III-13Intramural Research III-13Extramural Divisions III-13Vaccine Pricing in the US III-13Table 53: Vaccine Prices (In US$ per Dose) in the US:2002-2005 (includes corresponding Graph/Chart) III-14Regulatory Environment III-14Review Process Make Vaccines Safer III-14Imports-Exports Scenario: A Historic Perspective III-14Exports of Human Vaccines for 2004 III-14Table 54: US Domestic Exports of Vaccines for HumanMedicine for the Year 2004 (Value in '000 US Dollars)(includes corresponding Graph/Chart) III-15Imports of Human Vaccines for 2004 III-15Table 55: US Imports of Vaccines for Human Medicine forthe Year 2004 (Value in '000 US Dollars) (includescorresponding Graph/Chart) III-15Select Players III-16Alphavax, Inc. III-16Agenus Inc. (Formerly Antigenics, Inc.) (USA) III-16Antigenics, Inc. III-16Avax Technologies, Inc. III-16Baxter International, Inc. III-17Celldex Therapeutics, Inc. III-17Dendreon Corporation III-18Dynavax Technologies Corp. III-18Emergent BioSolutions Inc. III-19GenPhar, Inc. III-19Ligocyte Pharmaceuticals, Inc III-20Maxygen, Inc. III-20Micromet, Inc. III-21Novavax, Inc. III-21Progenics Pharmaceuticals, Inc. III-21Soligenix, Inc. III-22B.Market Analytics III-23Table 56: US Recent Past, Current & Future Analysis forHuman Vaccines (Prophylactic) by Product Group/ Segment -Pediatric Prophylactic Vaccines and Adult ProphylacticVaccines Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2009 through 2017 (includescorresponding Graph/Chart) III-23

Table 57: US Historic Re

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Doctor Proposes Information Tech to Reduce Prescription Errors

Tue, 15 May 2012 07:12:56 +0000

A study found that drug-related errors accounted for about a quarter of all preventable patient injuries. The study estimated that between 10 percent and 15 percent of prescriptions contain errors.

MIAMI, FL, May 15, 2012 /24-7PressRelease/ -- Many people think medical malpractice consists mainly of sensational cases, like accidentally leaving medical instruments inside a surgery patient. The reality is that medical malpractice often takes a more mundane but equally dangerous form: illegible handwriting on drug prescriptions. For example, pharmacists often misread doctor's handwritten prescriptions and give patients the wrong dosage -- or even the wrong medication -- for their medical problems.

A study of Canadian hospitals found that drug-related errors accounted for about a quarter of all preventable patient injuries. Pharmacists in the study estimated that between 10 percent and 15 percent of prescriptions contain errors.

These prescription drug errors may seem out of place in today's digital age. In addition to illegible handwriting, many prescriptions use confusing trade names for drugs and abbreviations for timing and dosage.

Researchers say that the health care systems of Canada and the U.S. have the least developed information technology for patient record-keeping, prescriptions and other medical tasks. According to Dr. Richard Alvarez, the most significant barrier for electronic record-keeping is not financial costs, but rather the traditional work habits of medical professionals.

Some medical professionals are embracing Dr. Alvarez's efforts to reduce prescription drug errors. By computerizing the process, mistakes caused by poor handwriting, abbreviations and dosage errors could decrease substantially. Computer software could require doctors to double-check orders. A pharmacy would receive a computer printout of prescription information rather than an illegible note. Errors could still happen in manual entry of data, but in far fewer numbers.

Dr. Alvarez argues for the use of information technology across the health care system to allow any medical professionals, including emergency room doctors, to instantly view a patient's medical history for treatment purposes. This technology would allow pharmacists to check whether a doctor's prescription is inconsistent with a patient's other medical conditions, allergies or prescriptions, and alert the doctor of the problem. This is particularly important for older patients with longer medical histories and more frequent need for drug prescriptions. In addition, doctors would more easily be able to track whether patients were correctly filling prescriptions.

The attorneys at Ferrer Shane, PL, are Miami medical malpractice lawsuit lawyers who assist clients throughout south Florida with a variety of legal services. For more information about their Miami law firm, visit their Web site, http://www.ferrerlaw.com/ or call them at (305) 262-2728.

Location:

Ferrer Shane, PL

North Kendall Drive, Suite 260

Miami, FL 33176

Phone: 305-929-8684

Toll-free: (888) 609-5947

Additional Resources:

Personal Injury Legal Blog: http://www.ferrerlaw.com/blog/

Auto Accident Blog: http://www.miamimotorvehicleaccidentsattorney.com/

DUI & Traffic Ticket Blog: http://www.miami-dui-defense-attorney.com/

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HealthEdSolutions.com Launches Health Education Article Special Section Focused on Emergency Department Professionals

Thu, 03 May 2012 07:20:30 +0000

Healthcare certification provider offers industry insights and training advice for emergency healthcare professionals

LINCOLN, NE, May 03, 2012 /24-7PressRelease/ -- To help healthcare professionals keep up with increasing demand for emergency department care, Health Education Solutions (HES), a leading provider of online healthcare certification courses including HeartCode ACLS, today released an Emergency Department health education article special section. This collection of informational articles is designed to help emergency department professionals equip themselves with the knowledge and skills they need to effectively care for more patients and prepare themselves for career advancement.

Between 1995 and 2008, emergency room visits increased by 28 percent according to the National Center for Health Statistics. As emergency departments continue to experience larger patient loads, the demand for professionals who understand how to effectively deliver cardiovascular life support interventions will grow as well.

"In order to provide effective lifesaving care to a patient, emergency care workers must have a strong understanding of both life support interventions and current trends that may impact delivery of care," said Melissa Marks, president of HES. "Health Education Solutions provides resources, information, and certification options to help emergency department nurses, doctors and other professionals keep their skills up to date and their knowledge current."

The Emergency Department health education article special section offers emergency department data, information and resources to help professionals learn more about effective delivery of care, as well as industry trends and career opportunities. It is available in Health Education Solutions' online research library, accessible via the HES homepage.

To help emergency department professionals equip themselves with essential lifesaving skills, HES offers online advanced cardiac life support (ACLS) certification and recertification courses. These online, self-paced courses are a convenient option for emergency care professionals who work long hours or have non-traditional schedules.

- Click here for ACLS certification

- Click here for ACLS recertification

HES additionally provides online American Heart Association HeartCode ACLS, pediatric advanced life support (PALS), stroke, basic life support (BLS), cardiopulmonary resuscitation (CPR), automated external defibrillator (AED), bloodborne pathogens and first aid training. Courses are intended for healthcare professionals, as well as individuals who want to be prepared to provide care in an emergency.

For professionals preparing for the ACLS and PALS exams, HES offers certification and recertification practice tests and quizzes. Questions included in both the tests and quizzes are similar to those included in the ACLS and PALS certification and recertification exams. The practice quizzes each include five sample questions and are available free of charge. The practice tests, which mirror the actual certification exam and include 50 timed multiple-choice questions, are available for $35. A portion of this fee can be applied to the purchase price of the full certification course. Individuals who take the practice tests and quizzes have the opportunity to immediately review incorrectly answered questions to understand where more studying may be needed.

For more information about training options for emergency care professionals, please visit http://www.healthedsolutions.com/articles/health-education-article.

About Health Education Solutions

Health Education Solutions (HES) is a leading provider of continuing education solutions for healthcare professionals. HES, a subsidiary of Nelnet Inc., offers ACLS and PALS courses developed in partnership with medical faculty at Union College in Lincoln, Nebraska.

Contact:

Shannon Fern

Communications Strategy Group

303.433.7020

sfern@csg-pr.com

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Study Confirms e-Prescribing Systems Reduce Medication Errors

Sat, 28 Apr 2012 07:13:41 +0000

A recent study in Australia confirmed what many U.S. health organizations and officials promote: e-prescribing systems help to reduce a variety of medication errors.

April 28, 2012 /24-7PressRelease/ -- A recent study in Australia confirmed what many U.S. health organizations and officials promote: e-prescribing systems help to reduce a variety of medication errors. While many healthcare hospitals and clinics in the U.S. have already implemented e-prescribing and other online medical systems and processes, the government and organizations like the American Medical Association (AMA) continue to encourage their adoption. Widespread use of e-prescribing systems helps protect patients and avoid painful and costly medication errors.

e-Prescribing Method

Electronic prescribing, or e-prescribing, systems help to automate the process of ordering, dispensing and paying for prescription drugs. Typically a physician enters a script in a patient's record on the e-prescribing system, which is then forwarded to a pharmacy of the patient's choice. The prescription history, insurance coverage and any possible medication interactions or side effects for a patient are also tracked within the e-prescribing system. In addition, refills and other authorizations are managed through the e-prescribing interface.

Australian Study Findings

Researchers in Australia studied the impact of two e-prescribing systems, Cerner Millennium and iSoft MedChart, in two Australian hospitals. The study assessed whether the e-prescribing systems reduced procedural and clinical medication errors, like unclear prescriptions or incorrect doses, without introducing new system errors. Overall findings indicated that these systems "significantly reduced prescribing errors, including serious errors." The major decline was to serious errors, mainly due to less procedural issues.

U.S. Implementation Initiatives

According to the AMA, two immediate benefits to physicians and their practices after implementing an e-prescribing system are time savings and Medicare incentive payments. Through the Medicare service, the government offers incentives for healthcare clinics and hospitals to purchase and install e-prescribing systems. Once implemented, providers can earn one percent of total Medicare Part B payments for 2011 and 2012. If prescribers do not use an e-prescribing system, they may be penalized by receiving lower Medicare payments.

Avoiding Medication Errors

Clinics and hospitals should take care to make process improvements, in addition to implementing an e-prescribing system, to avoid medication errors and ensure proper quality control. While it is difficult to entirely remove the possibility of human error from the prescription process, e-prescribing systems greatly improve the care patients receive by reducing medication errors like script illegibility, incorrect medications and wrong doses. However, some patients may find themselves the victims of painful medication errors.

If you recently experienced a medication error, whether as the result of prescription or dispensing errors, contact a local medical malpractice attorney for advice. If the physician was not using an e-prescribing system, there may be a chance there were procedural or clinical errors at issue for which you deserve compensation.

Article provided by Lancione & Lancione, PLL

Visit us at www.lancionelaw.com

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Joseph A. Osborne Appointed to Plaintiffs' Steering Committee for Transvaginal Mesh Litigation

Mon, 23 Apr 2012 07:14:07 +0000

On April 13, 2012, Judge Joseph R. Goodwin issued orders identifying Plaintiffs' Steering Committee for the transvaginal mesh MDL actions against manufacturing giants Johnson & Johnson, American Medical Systems, Ethicon and Boston Scientific.

WEST PALM BEACH, FL, April 23, 2012 /24-7PressRelease/ -- On April 13, 2012, Judge Joseph R. Goodwin issued orders identifying Plaintiffs' Steering Committee for the transvaginal mesh MDL actions against manufacturing giants Johnson & Johnson, American Medical Systems, Ethicon and Boston Scientific. Select attorneys from across the country have been appointed to serve in committee and other leadership roles to coordinate the prosecution of injury claims arising from transvaginal mesh devices manufactured by these entities. Attorney Joseph A. Osborne of Babbitt Johnson Osborne & LeClainche has been selected to serve as a member of the committee.

MDL centralization has the effect of placing all actions in a given docket before a single judge who can formulate a pretrial program that streamlines discovery and ensures that pretrial proceedings will be conducted in a manner leading to the just and expeditious resolution of all actions to the overall benefit of the parties.

Transvaginal mesh is a synthetic material implanted in a woman's pelvic region. The mesh is used to reinforce the weakened vaginal wall to repair pelvic organ prolapse (POP), or as support for the urethra or bladder neck for treatment of stress urinary incontinence (SUI). The mesh is also called urogynecologic surgical mesh, pelvic mesh, vaginal mesh or a bladder sling. According to the FDA, there is inadequate clinical evidence that mesh used transvaginally for POP repair is any more effective than traditional repair. In fact, the FDA said that patients implanted with mesh are exposed to risks they would not face in a traditional repair procedure.

On July 13, 2011, the FDA updated their former warnings to alert physicians and women that vaginal mesh complications are not rare, as previously believed, and that "it is not clear that transvaginal repair with mesh is more effective than traditional non-mesh repair." This warning came after the department had received more than 1,500 reports of problems with the mesh between 2008 and 2010, a five-fold increase from the number of reports received between 2005 and 2007.

It is anticipated that many more Transvaginal Pelvic Mesh lawsuits will be filed as a result of the failure rates that have been reported with these specific devices nationwide. Babbitt Johnson Osborne & LeClainche is known for its work on medical device cases and other members have served or are currently serving in leadership positions on other consolidated medical device cases. Transvaginal mesh claims are one of many currently being prosecuted by the firm.

If you or a loved one has suffered or been injured from a defective Pelvic Mesh Implant involving these specific designs, you may have a claim. Contact Babbitt Johnson Osborne & LeClainche today for a free, confidential case evaluation. Our lawyers are standing by to answer any questions you may have regarding the Transvaginal Pelvic Mesh implants. Babbitt Johnson Osborne & LeClainche is representing clients nationwide.

Joseph A. Osborne is an attorney with Babbitt, Johnson, Osborne & La Clainche.

Contact the firm at 561-531-5983, toll free at 888-407-5164 or at http://www.babbitt-johnson.com/.

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FDA Clears the Quest Diagnostics Simplexa® C. difficile Molecular Test

Wed, 11 Apr 2012 16:10:14 +0000

FDA Clears the Quest Diagnostics Simplexa® C. difficile Molecular Test

Test eliminates nucleic-acid sample extraction, for faster results

PR Newswire

MADISON, N.J. and CYPRESS, Calif., April 11, 2012 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its Simplexa C. difficile Universal Direct Test on the 3M™ Integrated Cycler.

The test, from the company's Focus Diagnostics business, is intended to aid in the diagnosis of Clostridium difficile-associated disease, one of the most common and dangerous acquired infections in healthcare settings. It uses a proprietary technique to eliminate the time consuming nucleic-acid sample extraction process required by many other molecular tests, for potentially faster results reporting for hospitals and clinical laboratories.

Simplexa tests, running on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively detect viruses, bacteria and other analytes. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C. difficile, including NAP1. The test uses a proprietary chemistry that eliminates the need for nucleic-acid extraction. Using the Simplexa test, hospital and other labs may complete the entire testing process in about an hour.

C. difficile-associated disease is a common and sometimes fatal healthcare-associated infection that causes diarrhea and other intestinal problems. As many as 14,000 people die of C. difficile-associated disease in the United States each year, according to the U.S. Centers for Disease Control and Prevention.

"Detecting and containing C. difficile associated disease is one of the greatest clinical challenges in today's healthcare environment," said Jay M. Lieberman, M.D., medical director, infectious disease, for Quest Diagnostics and Focus Diagnostics. "Fast, reliable PCR tests that are highly specific and sensitive in the detection of the tcdB gene, a toxin-B producing gene of C. difficile, are essential for identifying and treating this infection as well as containing its spread."

With the FDA clearance, the Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler is immediately available in the United States. Focus Diagnostics launched the test in Europe during the second quarter of 2011.

About Simplexa®

Focus Diagnostics, a wholly-owned business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M™ Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M™. Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional FDA-cleared Simplexa tests aid the detection of influenza A and B and respiratory syncytial virus. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr and BK viruses, are CE marked and distributed in Europe. In 2011, the Simplexa/3M technology won a gold Medical Design Excellence Award in the in vitro diagnostics category and an Edison Award for new science and medical diagnostic product.

To learn more about or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe), or visit SimplexaDx.com or FocusDx.com.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

Quest, Quest Diagnostics, Simplexa and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics.

Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900

SOURCE Quest Diagnostics

Is Your Doctor Telling You the Whole Truth? Maybe Not, Says New Study

Sun, 08 Apr 2012 07:11:14 +0000

A nationwide poll has troubling implications for patients who rely on their doctor's advice.

April 08, 2012 /24-7PressRelease/ -- Is Your Doctor Telling You the Whole Truth? Maybe Not, Says New Study

In our culture, doctors have an almost mythical reputation as the wielders of exclusive knowledge about the mysteries of the human body. Sometimes this standing allows us to forget that, just like their patients, physicians are only human.

One new study bluntly reveals how human many doctors really are. New research, published in the prestigious journal Health Affairs, paints a grim picture about the level of dishonesty infecting the medical profession. The report just may have you wondering whether you really know the person you have entrusted with your wellbeing -- and reaching for the number of a respected NYC medical malpractice law firm.

Physician Dishonestly About Drug Company Ties, Medical Mistakes Prevalent

Researchers surveyed almost 2,000 practicing physicians throughout the United States to compile the results of the Health Affairs study. They captured information about a wide spectrum of untruthfulness.

Some doctor dishonesty sprang from honorable intentions: more than half of physicians told patients their prognosis looked better than it did (55 percent admitted to delivering an inaccurately positive health report in the last year); others attempted to "scare" patients out of bad health behavior by making a prognosis seem more threatening than it truly was. Yet, studies consistently show that patients prefer the truth about their medical condition, even if it is grim -- understandable, given that what a doctor may see as a white lie in this context precludes the patient from exercising his or her own autonomous judgments about the situation.

Noble, if misguided, intentions did not account for all doctor mendacity reported in the study. Many doctors were unwilling to reveal their own ties to pharmaceutical or medical device companies: about 40 percent said they do not believe it is necessary to tell patients when they have a financial stake in companies whose products they may be recommending.

A significant minority of doctors responded troublingly when asked about reporting medical mistakes to patients. Approximately one-third of physicians said they did not completely agree that patients should always be informed about serious medical errors (and just over 10 percent admitted to telling a patient a lie in the last year). Even though such lies may be intentioned as a means of dodging a medical malpractice suit, the study's lead author noted that they often have the opposite effect: patients are more likely to pursue legal claims against doctors who are not open and honest about their mistakes.

Doctor Lies Can Lead To Legal Culpability

A doctor's dishonesty can cause you harm in many ways, from delaying the diagnosis of a serious health threat to usurping your right to make your own medical decisions based on full and accurate information. If you believe a physician's untruthfulness may have had a negative impact on yourself or a family member, contact a medical malpractice lawyer to learn more about your right to compensation.

Article provided by Powers & Santola, LLP

Visit us at www.powers-santola.com

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Study Finds Traumatic Brain Injuries More Common Than Once Thought

Sat, 07 Apr 2012 07:10:24 +0000

New findings by Mayo Clinic researchers show traumatic brain injuries occur at higher rates than previously thought.

April 07, 2012 /24-7PressRelease/ -- Study Finds Traumatic Brain Injuries More Common Than Once Thought

Scientists and medical professionals understand a lot more about the long-term effects of traumatic brain injuries now than they did even just a few years ago. However, until recently, most didn't have a good understanding of how frequently these injuries occur.

Researchers at the Mayo Clinic recently took on this issue, and their findings show that traumatic brain injuries occur much more frequently than was previously thought.

The researchers devised a new method for classifying head injuries into categories of "definite," "probable" and "possible" TBI, based on patients' reports of symptoms including unconsciousness, dizziness or nausea.

They then used this method to review a collection of medical records that spanned several decades. In doing so, they found that TBIs may occur in as many as 558 per 100,000 people. The Centers for Disease Control and Prevention previously estimated the rate to be about 341 per 100,000 people. Approximately 60 percent of the brain injuries the Mayo Clinic researchers identified fell outside of the CDC's standard categorization metrics.

Risk Factors for TBI

Traumatic brain injuries can occur when the head strikes a hard surface or when a deceleration-type injury causes the brain to move around inside the cranial cavity. They are frequently seen in motor vehicle accident victims and in athletes who play contact sports.

The researchers found that some groups of people like men and the elderly are more at risk for TBIs than others. Young people, however, were more likely to report symptoms that indicated a "possible" brain injury.

Will Study Lead to Better Care?

In the wake of the findings, many are beseeching the CDC to revise its brain injury classification system. They hope that a better understanding of TBI frequency will translate to more effective methods for preventing and treating brain injuries.

The findings should also serve as a reminder to all of us that brain injuries aren't always obvious after an accident. If you are concerned that you or a loved one may have suffered a brain injury -- for example, because you are experiencing nausea, headaches, dizziness or unexplained changes in mood or cognition -- be sure to seek help from a medical professional.

Article provided by Spangenberg Shibley & Liber LLP

Visit us at www.spanglaw.com

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Association of Immunization Managers Encourages Collaboration and Investment in Immunization and Emergency Preparedness Programs to Prepare for Next Pandemic

Wed, 04 Apr 2012 20:01:35 +0000

Association of Immunization Managers Encourages Collaboration and Investment in Immunization and Emergency Preparedness Programs to Prepare for Next Pandemic

PR Newswire

ROCKVILLE, Md., April 4, 2012 /PRNewswire-USNewswire/ -- The Association of Immunization Managers (AIM), representing the 64 federally funded state, territorial and large urban area immunization programs, applauds Emory University's Rollins School of Public Health for its findings in support of collaboration between immunization and emergency preparedness programs as the key to successful pandemic influenza response.

The Emory Preparedness and Emergency Response Research Center (Emory PERRC) manuscript entitled Perspectives of Immunization Program Managers on 2009-2010 H1N1 Vaccination in the United States: A National Survey, published in the March 2012 issue of Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, highlights the value of ongoing collaboration and partnership between programs. Immunization programs that coordinated with their emergency preparedness programs to conduct pre-pandemic mass vaccination events were more likely to perceive their emergency preparedness staff as effective during the H1N1 pandemic than those who had not.

Pandemic Preparedness Collaboration Principles, released by AIM and available at www.immunizationmanagers.org, encourage state, territorial and local immunization and emergency preparedness programs to establish relationships and routine communication; share information, resources and technology; and conduct ongoing drills to successfully prepare for the next pandemic.

"The value of partnership cannot be understated," said AIM Chair and Washington State immunization program manager Janna Bardi. "In Washington State, longstanding relationships developed through routine planning drills and emergency exercises paid off during our H1N1 response." Washington State provided more than 2.8 million doses of H1N1 vaccine and vaccinated 30% of its population.

"The research by Emory and AIM shows that planning and collaboration work," said AIM Executive Director Claire Hannan. "Ongoing investment in staff, drills, exercises and technology improvements is critical to future success. Budget cuts have resulted in furloughs, hiring freezes and a shrinking public health work force. But disease doesn't respect fiscal or geographic boundaries. The next pandemic or disease outbreak is only a plane ride away. We must continue to cultivate relationships across agencies and invest in both immunization and preparedness programs."

AIM will feature its pandemic preparedness collaboration principles in an April 10th, 2012 training broadcast, Strategies for Successful Integration of Immunization and Emergency Preparedness Programs in Planning and Practice, co-hosted by the South Central Preparedness and Emergency Response Learning Center, Emory PERRC and the Association of State and Territorial Health Officials for immunization program managers, emergency preparedness directors and state and local staff. More information can be found at, http://www.immunizationmanagers.org/policies_pub/imm_prog_emerg_collab_principles.phtml.

The Association of Immunization Managers is a non-profit membership organization comprised of the 64 state, territorial and urban area immunization programs which receive federal funding for immunization through the Section 317 program. AIM is dedicated to enabling immunization program managers to work together and with federal, state, and local partners to effectively prevent and control vaccine-preventable diseases. www.immunizationmanagers.org.

The Emory PERRC study was supported by a grant from the Centers for Disease Control and Prevention (CDC), grant # 5P01TP000300, to the Emory Preparedness and Emergency Response Research Center, Emory University (Atlanta, GA). The work of the South Central Preparedness and Emergency Response Learning Center at the University of Alabama at Birmingham is supported under a cooperative agreement from the Centers for Disease Control and Prevention (CDC) grant 1U90TP000400-01.

SOURCE Association of Immunization Managers

Abbott's PLEX-ID Molecular System and Tests for Broad Microbial Identification Obtain CE Marking

Fri, 30 Mar 2012 10:00:00 +0000

Abbott's PLEX-ID Molecular System and Tests for Broad Microbial Identification Obtain CE Marking

PR Newswire

WIESBADEN, Germany, March 30, 2012 /PRNewswire/ --

- New PLEX-ID System and Three Clinical Tests Introduced in the European Union

Abbott (NYSE: ABT) announced today it has obtained CE Marking (Conformite Europeene) in the European Union to market its rapid, high-throughput PLEX-ID™ instrument, along with three assays for use on the system: PLEX-ID Viral IC Spectrum, PLEX-ID BAC Spectrum BC and PLEX-ID Flu.

PLEX-ID, which is based on molecular diagnostic technologies, addresses a significant unmet need for rapid detection and identification of a broad range of microbes that cause infections in patients. It provides results in less than eight hours instead of the days or even weeks required for traditional culture methods. The unique advantage of the system is the ability to characterize a very wide range of microorganisms directly from clinical specimens, thus minimizing both the amount of time and laboratory work required to provide physicians important information they can use to best tailor treatment for the patient.

"Ensuring that patients receive the most appropriate antimicrobial therapy as rapidly as possible has the potential to reduce inappropriate antibiotic prescribing, and help to reduce or slow the development of resistant bacterial strains," said Jacques Schrenzel, M.D., head of the Bacteriological Laboratory, University Hospital Geneva in Geneva, Switzerland.

"PLEX-ID is the only available diagnostic technology that is capable of identifying a wide range of bacteria, viruses, fungi, and certain parasites in hours," said Murthy Simhambhatla, Ph.D., head of Abbott's Ibis Biosciences business. "The introduction of the PLEX-ID provides physicians and laboratorians a revolutionary new platform for the rapid etiologic identification of a wide variety of pathogens in patients."

Assays to Rapidly Identify Pathogens in Seriously Ill Patients

Research presented in several global scientific venues has shown that the PLEX-ID technology offers rapid detection and characterization of a wide range of pathogens, which can be extremely important in patients who have an impaired immune system such as those with cancer or patients who have had a transplant.

The PLEX-ID Viral IC Spectrum assay is designed to detect and identify 11 viral families with more than 250 species of important systemic viral pathogens, including herpes simplex virus (HSV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human adenovirus, human enterovirus, BK and JC polyomaviruses, and parvovirus B19, directly from plasma specimens. These viruses represent a significant threat to vulnerable patients with weakened immune systems. Systemic viral infections are a serious problem, occurring in one out of every six transplant patients. Earlier detection can enable physicians to act more quickly to manage the patient's infection.

The PLEX-ID BAC Spectrum BC assay can detect and identify nearly 400 species of bacteria, and also can detect the presence of genetic markers that determine bacterial resistance to certain antibiotics. In addition, the test can identify and classify species of Candida, a fungus that is an increasingly common cause of serious systemic infections. The assay performs this analysis on blood culture positive specimens. Abbott plans to introduce a modified version of the assay in Europe later this year which is designed to analyze the blood sample immediately after it reaches the lab rather than having to first wait for the organism to grow in culture.

The PLEX-ID Flu assay is intended for detection and identification of known influenza A viruses, newly emerging influenza A strains, and influenza B.

About PLEX-ID

The unique power of PLEX-ID is achieved by combining the high levels of sensitivity and specificity of polymerase chain reaction (PCR) technology with the precision and accuracy of mass spectrometry. This breakthrough combination allows for identification and characterization of broad groups of organisms without having to narrowly focus on detecting each organism individually. The result is the ability to cover many more organisms than other rapid approaches. PLEX-ID provides comprehensive results that can enable physicians to act more quickly and manage patients more effectively.

In 2009, PLEX-ID was recognized by both The Scientist and the Wall Street Journal as one of the top scientific innovations of the year. The Scientist honored the system because it can detect and characterize a broad range of microorganisms in any given sample. The Journal selected PLEX-ID as its Gold winner of the 2009 Wall Street Journal Technology Innovation Awards because it is designed to alert health officials to new disease strains, including H1N1 for public health surveillance, may also guard against bioterrorism and help hospitals identify antibiotic-resistant bacteria in their facilities. PLEX-ID is currently being used for non-diagnostic purposes by government agencies, law enforcement, health care manufacturers and other organizations.

About Ibis Biosciences

Ibis Biosciences was acquired by Abbott in January 2009 with the focus to deliver an innovative approach to the detection and characterization of a broad array of microorganisms and to contribute to Abbott's expanding role in molecular testing. This acquisition led to the development of the PLEX-ID system that was designed to the issues and challenges of traditional technology used in microbial identification in a single system. More information is available at http://www.ibisbiosciences.com.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available at the company's Web site at http://www.abbott.com.

Federal Court Begins the Selection Process for Initial Avandia Suits

Thu, 29 Mar 2012 07:20:08 +0000

A federal district court judge recently indicated that her court is preparing to schedule for trial almost one hundred cases involving the diabetes drug Avandia.

March 29, 2012 /24-7PressRelease/ -- A federal district court judge recently indicated that her court is preparing to schedule for trial almost one hundred cases involving the diabetes drug Avandia. The lawsuits revolve around allegations that the use of Avandia - manufactured by drug-maker GlaxoSmithKline (GSK) - can lead to an increased risk of heart attacks.

Problems Associated with Avandia Use

Avandia, a drug used to treat type 2 diabetes, gained FDA approval in 1999. The active ingredient in Avandia makes the body more sensitive to insulin, resulting in reduced blood sugar levels. However, as early as May 2007, The New England Journal of Medicine published research that pointed to an almost 43 percent increase in the chance of heart attacks for individuals who used Avandia.

Following the publication of this study, internal reports showed that Avandia maker GlaxoSmithKline was potentially aware of the risks but did nothing to warn patients of the possible side effects of Avandia. The FDA has now required GSK to list the cardiovascular side effects on the label of the drug to ensure patients are aware of the risks. Tens of thousands of lawsuits have been filed, but Avandia is still on the market.

Avandia Order

Recently, the Honorable Christine Rufe - who is the judge assigned to the Avandia cases in the Eastern District of Pennsylvania - challenged the parties to settle 85 percent of their litigant's claims in 75 days. As a result of this, around 25,000 multi-district lawsuits were resolved through the mediation process. But a recent statement from Judge Rufe shows that mediation will no longer be the focus of the court. The remaining cases will be set for trial - starting with around a hundred of the oldest heart attack cases.

In a March 19 court order, Judge Rufe directed the attorneys of the roughly one hundred plaintiffs selected to provide Plaintiffs' Coordinating Counsel with the names of their clients who are claiming to have suffered heart attacks attributed to their Avandia use, along with a summary of their cases. Judge Rufe further ordered the Plaintiffs' Coordinating Counsel to then confer with GSK to compile a list of agreed-upon heart attack cases - the court will then select cases for trial from this pool.

If you or a loved one has suffered an adverse side effect you believe is a result of Avandia use, it is important to contact an experienced Avandia attorney to be advised of your rights and options.

Article provided by Aaron M. Levine & Associates

Visit us at www.aaronlevinelaw.com

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Security Disability Benefits for Clients With Hidradenitis Suppurativa

Wed, 28 Mar 2012 07:12:06 +0000

Social Security disability attorneys who understand Hidradenitis Suppurativa can get Social Security Disability benefits for their clients with this condition.

COLUMBUS, OH, March 28, 2012 /24-7PressRelease/ -- According to the Mayo Clinic, Hidradenitis Suppurativa (HS) is chronic inflammation and deep lesions of the skin, particularly in sensitive areas of the armpits and groin. Possible causes may involve a combination of genetics, hormones, and other factors. HS may impact 1-2% of the population, but absolute numbers are uncertain.

Given how relatively rare this medical condition is, Social Security disability attorneys who understand this condition can get Social Security Disability benefits for their clients with Hidradenitis Suppurativa.

How does Social Security Disability evaluate Hidradenitis Suppurativa? Social Security must identify the diagnosis to evaluate it. Successful Social Security disability attorneys need to point this diagnosis out to Social Security. Medical records are not always consistent. A typical history is ongoing primary care treatment for recurring boils that require in-office intervention. Of concern, historical medical record histories may initially fail to diagnose HS until the lesions have persisted in various forms and locations on the body for a few years. There are possible reasons for this medical oversight. More about this below.

Credibility usually high for Social Security benefits clients with Hidradenitis Suppurativa. Clients have typically worked with developing symptoms for over ten years or more before succumbing to the progressive lesions and pain that persists despite surgical intervention.

Social Security reviews Hidradenitis Suppurativa claims under a special definition of disability called a listing. The "listing" for Hidradenitis Suppurativa is:

Listing 8.06

Hidradenitis suppurativa, with extensive skin lesions involving both axillae, both inguinal areas or the perineum that persist for at least 3 months despite continuing treatment as prescribed.

How do experienced Social Security disability attorneys get approvals at Social Security hearings for clients with Hidradenitis Suppurativa? They pay attention to the timing of the diagnosis. The chronicity of the HS lesions may not fully manifest to physicians initially - particularly if clients see different primary care physicians from appointment to appointment or change facilities from time to time. Over time, however, the diagnosis of HS should relate back to previous care for the symptoms. Good Social Security disability attorneys get retrospective input from treating physicians.

Good attorneys must anticipate and address deficiencies in the early medical evidence of HS. This may stem from where the lesions are. Clients may attempt to suffer alone through periods of HS lesions in private areas of their bodies. Despite the Social Security Administration's assumptions to the contrary, it is not always easy to establish care for personally sensitive problems. Good attorneys know this and put delays in care into context.

Good attorneys also argue to administrative law judges that delays in diagnosis have more to do with practical than medical factors. Reporting the full constellation of symptoms right away cannot be expected because the chronic nature of the "commonplace" boils is not always apparent to clients, let alone physicians.

What should your Social Security Disability attorney know about Hidradenitis Suppurativa? Judges and medical experts are, on a whole, unfamiliar with HD. In judges' defense, they may not see these issues raised in many cases. Medical experts (ME's) at hearings, however, rarely if ever have a background in dermatology. So, they may not be as familiar (and miss) Hidradenitis Suppurativa because it is a condition that may not normally arise in other specialty areas.

What must your Social Security disability attorney do at your Social Security hearing? He or she must raise the issue of Listing 8.06 and argue that the diagnosis, duration, location, impact, and daily care of your HD impedes full-time employment. Additional legal documentation, as well, can win claims. For help with your Social Security benefits claim, get professional legal advice from an experienced Social Security Disability law firm.

Hoglund Law Firm

Website: http://www.ohiosocialsecuritydisability.com

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