Pharmaceuticals

22 May 2009 -- GSK announced today that the US Department of Health and Human Services (HHS) has placed initial orders for A (H1N1) influenza vaccine antigen and the company’s proprietary adjuvant system, AS03, to support its pandemic influenza preparation efforts.

GSK manufactures both a traditional vaccine antigen, which will be made from the recently isolated A (H1N1) influenza strain, as well as an adjuvant system. An adjuvant system can be added to the antigen at time of administration.

GSK expects to fill the US adjuvant order within the next few months. The first doses of the vaccine antigen are expected to be available four to six months after the company receives the H1N1 seed strain, subject to regulatory approval. The new vaccine will be tested in clinical trials.    » read more »

Definitive agreement to acquire EBEWE Pharma's specialty injectables business for EUR 925 million (USD 1.2 billion) in an all-cash transaction

May 20, 2009 -- Basel, May 20, 2009 - Novartis has signed a definitive agreement to acquire the specialty generic injectables business of EBEWE Pharma, providing Sandoz - the Group's generic pharmaceuticals division - an opportunity to create a strong global platform for future growth while improving access for patients worldwide to many generic oncology medicines.

Under terms of the agreement, Novartis will acquire this business for EUR 925 million (USD 1.2 billion) in cash. Excluded from this transaction is EBEWE Pharma's separate injectable neurological products business.    » read more »

Applications Based on Data from Nearly 1,500 Patients in Two of the Largest Studies Ever Conducted in Chronic Lymphocytic Leukemia

SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. – May 19, 2009 – Genentech, Inc. and Biogen Idec (Nasdaq: BIIB) today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.    » read more »

May 21, 2009 -- Genzyme Corporation (Nasdaq: GENZ) announced today that it has submitted the final documentation to address all items in the FDA’s complete response letter for Lumizyme™ (alglucosidase alfa), produced at the 2,000 L bioreactor scale.

The submission included clinical data requested by the FDA from Genzyme’s Pompe Registry. The FDA has agreed that these data can fulfill the requirements for a verification study to demonstrate the clinical benefit of Lumizyme. Also included in the submission were the Risk Evaluation and Mitigation Strategy (REMS) and the final label for the product.    » read more »

May 20, 2009 -- NEW YORK -- Pfizer Inc announced today that it has entered into licensing agreements with two pharmaceutical companies based in India, strengthening its position in emerging markets and significantly expanding its portfolio of medicines in its Established Products Business Unit.

Off-patent medicines, including branded generics, represent one of the fastest growth segments in the global pharmaceutical market. This is especially true in emerging markets where costs and access are primary drivers of off-patent medicine growth.    » read more »

Drug Company Allegedly Failed to Pay Hundreds of Millions in Rebates to Medicaid Program

May 18, 2009 -- WASHINGTON – The United States and 16 states have joined in two whistleblower suits filed in the District of Massachusetts against the drug manufacturer, Wyeth, alleging that the company knowingly failed to give the government the same discounts it provided to private purchasers of its drugs, as required by laws governing the Medicaid program.

As a result, Wyeth allegedly avoided paying hundreds of millions in rebates due to state Medicaid programs for its drugs, Protonix Oral and Protonix IV. These drugs belong to a class of drugs known as proton pump inhibitors (PPI), which are used to suppress stomach acid.    » read more »

Decision Underscores Need for Reform at FDA

March 23, 2009 -- A federal district court today ruled the Food and Drug Administration (FDA) violated its own rules when it restricted over-the-counter sales of the emergency contraceptive Plan B to women over 18. The New York City-based court ordered the FDA to reconsider its decisions regarding over-the-counter access and age restrictions and to extend over-the-counter access to 17 year olds within 30 days.    » read more »

March 11, 2009 -- Consumer Federation of America welcomes the appointment of Dr. Margaret Hamburg and Dr. Joshua Sharfstein as commissioner and principal deputy commissioner of the U.S. Food and Drug Administration. Their resumes are extremely impressive and both are familiar with the FDA’s failure to protect the public from foodborne illness.    » read more »

March 11, 2009 -- WASHINGTON—AARP today applauded the introduction of bipartisan legislation to lower the cost of prescription drugs. The Access to Life-Saving Medicine Act, introduced by Chairman Henry Waxman (D-CA), Rep. Frank Pallone (D-NJ), Rep. Nathan Deal (R-GA) and Rep. Jo Ann Emerson (R-MO), will create a needed pathway for the approval of safe generic versions of costly biologic drugs. A statement from AARP Executive Vice President Nancy LeaMond follows:

“Biologic drugs are treating some of the most devastating diseases Americans face, like cancer, anemia and multiple sclerosis. But for too many people, these life-saving medicines are simply out of reach because of their overwhelming price tags.    » read more »

Discovery May Aid in the Development of Anti-Hepatitis C Virus Drugs

JUPITER, FL, March 9, 2009—A team from The Scripps Research Institute has found a way to inhibit viral production of the Hepatitis C virus (HCV). The advance has the potential to accelerate future research on the virus life cycle and to aid in the development of novel HVC drugs.

The research, led by Professor Donny Strosberg of Scripps Florida, was published on March 4, 2009, in the Journal of General Virology's advance, online edition, Papers in Press.    » read more »

Says State of Economic Emergency Means Families Need Help Today

March 9, 2009 -- HARRISBURG - As the grip of a national recession continues to tighten around families across Pennsylvania, Governor Edward G. Rendell today announced unprecedented emergency executive actions intended to provide immediate relief to citizens in need and spark economic recovery.

The Governor’s proposed 2009-10 budget, which is awaiting action now by the General Assembly, includes a significant economic relief and recovery agenda that would provide tuition relief, health care assistance and job creation. However, the Governor said immediate action is needed because some families cannot wait any longer for help.    » read more »

Combined Company Positioned For Sustainable Growth Through Scientific Innovation And A Stronger, More Diversified Product Portfolio; Powerful Joint R&D Pipeline with Strong Candidates in All Development Phases Doubles the Number of Late-Stage Compounds to 18

WHITEHOUSE STATION, N.J. and KENILWORTH, N.J., March 9, 2009 - Merck & Co., Inc. (NYSE: MRK) and Schering-Plough Corporation (NYSE: SGP) today announced that their Boards of Directors have unanimously approved a definitive merger agreement under which Merck and Schering-Plough will combine, under the name Merck, in a stock and cash transaction.    » read more »

Statement of Brian Wolfman, Director, Litigation Group at Public Citizen

March 4, 2009 -- "We are extremely gratified that the U.S. Supreme Court today in Wyeth v. Levine upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.

Drug companies are not perfect, and they sometimes fail to identify and inform doctors and the Food and Drug Administration (FDA) of problems with their products or their products’ labels. Nor is the FDA perfect. It is overworked and underfunded, and it depends almost entirely on drug companies for information about the safety and effectiveness of drugs.    » read more »

Pharmaceutical Companies Allegedly Marketed the Drug Natrecor for a Use Not Approved by the Food and Drug Administration

February 19, 2009 -- WASHINGTON – The United States has intervened in two whistleblower suits filed in the Northern District of California against the drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc., alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA) and caused false and fraudulent claims to be submitted to the federal health care programs, the Justice Department announced today. Such an unapproved use is also known as an "off-label" use because it is not included in the drug’s FDA approved product label.    » read more »

August 11, 2008 -- LANSING - Michigan Attorney General Mike Cox today announced that funds from a settlement with the pharmacy benefits management company, Caremark, will be used to promote Michigan's drug cost website, www.michigandrugprices.com. Michigan was part of a 28 state settlement with Caremark.

Caremark engaged in deceptive business practices by encouraging doctors to switch patients to different brand name prescription drugs and representing that the patients and/or health plans would save money. Doctors were not adequately informed of the effect this switch would have on costs to patients and health plans.    » read more »