Pharmaceuticals

March 16, 2010 -- WASHINGTON – American pharmaceutical manufacturer Alpharma Inc. has agreed to pay $42.5 million to resolve False Claims Act allegations in connection with the marketing of the morphine-based drug, Kadian, the Justice Department announced today.

The settlement resolves allegations that, between January 1, 2000 and December 29, 2008, Alpharma paid health care providers to induce them to promote or prescribe Kadian, and made misrepresentations about the safety and efficacy of the drug, which is used to treat chronic moderate to severe pain. Alpharma is now a wholly-owned subsidiary of Bristol, Tenn.-based King Pharmaceuticals Inc.    » read more »

New bill aims to reform contracting practices, achieve multimillion dollar savings on federal drug benefits

January 21, 2010 -- WASHINGTON, DC – Representative Stephen F. Lynch (D-MA), Chairman of the House Subcommittee for the Federal Workforce, Postal Service, and the District of Columbia introduced a bill today that, if passed, would save the federal government and federal employees hundreds of millions of dollars by reforming the way insurers contract with the Federal Employees Health Benefits Program (FEHBP) to provide prescription drug benefits to federal employees.

Change to Win applauds Representative Lynch and the Subcommittee for their leadership on this issue.    » read more »

January 15, 2010 -- Washington, DC -- Congresswoman Rosa DeLauro (CT-3) released the following statement today in response to the expanded recall of Tylenol products.

A report by the Food and Drug Administration shows that McNeil Healthcare, LLC, the Johnson & Johnson division that manufactures Tylenol, received complaints about an uncharacteristic musty odor emanating from Tylenol Arthritis Relief Caplets in 2008. After multiple consumer complaints of stomach problems, a recall was initiated in September of 2009. The FDA investigated, and has determined that the quality control testing at McNeil failed, as did the company’s response and notification of the public.    » read more »

Suit Filed Against J&J for Paying Kickbacks to Nation’s Largest Nursing Home Pharmacy

January 15, 2010 -- WASHINGTON — The United States has filed a civil False Claims Act complaint against drug manufacturer Johnson & Johnson (J&J) of New Brunswick, N.J., and two of its subsidiaries, Ortho-McNeil-Janssen Pharmaceuticals Inc. and Johnson & Johnson Health Care Systems Inc., the Justice Department announced today.    » read more »

First prequalification for an H1N1 pandemic vaccine

December 1, 2009, London UK -- GlaxoSmithKline (GSK) today announced that the World Health Organization (WHO) has awarded prequalification for global use of Arepanrix™, GSK’s adjuvanted H1N1 pandemic vaccine manufactured in Canada. This is the first prequalification for an H1N1 pandemic vaccine, and is a key step in ensuring the vaccine can be distributed to developing countries.

The WHO prequalification project is a service provided by the WHO to facilitate access to medicines that meet unified standards of quality and safety.    » read more »

10 Most Prescribed Drugs Marked Up 213% Higher Than in Canada

11.22.09 -- New York City – Representative Anthony Weiner (D – Brooklyn and Queens), a member of the House Energy and Commerce Health Subcommittee and Representative Carolyn Maloney (D – Manhattan and Queens), following news reports that drug companies have been raising drug prices for the most popular drugs in anticipation of health care reform passing, released a new study showing drug companies charging New York consumers 213% more than Canadians for the ten most prescribed drugs.    » read more »

November 20, 2009 -- Today, Congressman Dan Lipinski (IL-3) denounced the pharmaceutical industry for sharply increasing drug prices in the middle of a recession and renewed his call to eliminate the industry’s tax break for advertising and promotion, which would save taxpayers $50 billion or more over 10 years. Congressman Lipinski also supports asking the Government Accountability Office to quickly investigate recent drug pricing trends and to report to Congress on drug prices on a regular basis in the future.    » read more »

Senator asks for probe of drug-industry price hikes made in advance of expected health care changes

November 18, 2009 -- WASHINGTON, D.C. - U.S. Senator Bill Nelson today asked the inspector general at the Department of Health and Human Services to look into reports that drug makers are jacking up the prices on widely used brand-name prescriptions and taking windfall profits in advance of possible health care reforms. And the Florida Democrat will offer an amendment to the health care bill that would make the pharmaceutical giants pay more of the tab.    » read more »

NEW YORK & GENEVA -- Pfizer Inc and Drugs for Neglected Diseases initiative (DNDi) have signed an agreement that is designed to facilitate advancements in the battle against human African trypanosomiasis (HAT), visceral leishmaniasis (VL) and Chagas disease, which afflict vulnerable populations in the developing world. Under the agreement, DNDi will have access to the Pfizer library of novel chemical entities, in order to screen it for compounds that have the potential to be developed into new treatments.    » read more »

Congresswoman Chellie Pingree says drug companies practicing "bait and switch"

November 16, 2009 -- Congresswoman Chellie Pingree expressed outrage today over published reports that the nation’s pharmaceutical companies raised prices last year more than any year since 1992.

“The drug companies promised us they would deliver $8 billion in savings into the health care system,” Pingree said. “What they failed to tell us was that they apparently planned to jack up prices by $10 billion first. It sounds like classic bait and switch scheme to me.”

According to today’s New York Times, the wholesale price of brand name prescription drugs went up 9% last year, a year in which overall consumer prices actually fell 1.3%.    » read more »

Merck Expresses Confidence in the Efficacy and Safety Profiles of ZETIA® (ezetimibe) and VYTORIN® (ezetimibe/simvastatin) as Effective Medicines for Managing Elevated Cholesterol

ORLANDO, Fl., Nov. 15, 2009 – At the American Heart Association meeting today, Merck & Co., Inc. said it is confident in the safety and efficacy profiles of ZETIA® (ezetimibe) and VYTORIN® (ezetimibe/simvastatin), and issued the following comment in response to misinterpretation of results from a small 200-patient imaging study called ARBITER 6.    » read more »

Upfront and potential consideration of over $500 million

16 November 2009, London UK, Rockville US -- GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) today announced an exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAX®), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.    » read more »

US interim data show lower doses of antigen may suffice to generate a protective immune response against A(H1N1)

Basel, November 17, 2009 - Novartis announced today new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (>=65 years of age).    » read more »

November 16, 2009 -- Genzyme Corporation (Nasdaq: GENZ) announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme™ (alglucosidase alfa) for the treatment of Pompe disease. In its letter, the agency stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved.

Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed.    » read more »

November 13, 2009 -- Genzyme Corp. (Nasdaq: GENZ) announced today that it has issued letters to U.S. healthcare providers regarding its enzyme replacement products Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta), Myozyme® (alglucosidase alfa), Aldurazyme® (laronidase), as well as Thyrogen® (thyrotropin alfa for injection), filled at its Allston Landing manufacturing facility. The letters remind providers of the U.S. product labeling recommendations advising both visual inspection of vials and in-line filtration of enzyme replacement products to address the potential presence of foreign particles.    » read more »