Pharmaceuticals

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 »

Collaboration goal is to advance 4 to 5 antibodies per year into clinical development

Paris, France – November 10, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today that they have entered into agreements to expand and extend their existing global collaboration to discover, develop, and commercialize fully-human therapeutic monoclonal antibodies.    » read more »

First new over-the-counter treatment for frequent heartburn sufferers in six years

Basel, November 12, 2009 - Novartis announced the availability of Prevacid®24HR (lansoprazole delayed-release capsules 15 mg/acid reducer) over-the-counter in pharmacies and retail stores across the US to treat frequent heartburn. Prevacid®24HR received US Food and Drug Administration (FDA) approval in May 2009. It is the first and only over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn in its original formulation.    » read more »

Approval marks an important milestone in the process of replacing 50 year-old egg-based flu vaccine production with modern biotechnology

November 05, 2009 -- Basel, November 5, 2009 - Novartis announced today that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura®. Novartis continues to pursue registration in other major countries, including Japan and Switzerland.    » read more »

Oct. 19, 2009 -- GlaxoSmithKline [NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved Votrient™ (pazopanib) to treat patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. Approximately 57,700 people in the U.S. will be diagnosed with kidney cancer this year, and 13,000 people will die from this disease.    » read more »

Addition of Fort Dodge Animal Health Products Diversifies and Enhances Pfizer’s Already Robust U.S. Portfolio

October 19, 2009 -- NEW YORK -- A new Pfizer Animal Health was unveiled last week as Pfizer's acquisition of Wyeth, including its subsidiary Fort Dodge Animal Health, was completed. Pfizer Animal Health is now the world’s leader in the discovery, development, manufacture and sales of veterinary vaccines and medicines for livestock and companion animals.    » read more »

FDA issues warning to consumers to avoid purchasing flu drugs online; WHO says counterfeit drugs are a $35 to $40 billion a year industry

October 16, 2009 -- Huntington, NY – On Friday, Rep. Steve Israel (D-Huntington) called for Congress to act on his legislation, the Counterfeit Drug Enforcement Act of 2009 (H.R.2726) – also known as Tim Fagan’s Law, amid warnings about counterfeit drugs related to the H1N1 virus. Websites selling fake Tamiflu and other purported flu treatments are proliferating and preying on fears of the H1N1 virus.    » read more »

"Bills would close a loophole used by brand name drug companies to delay market introduction of affordable generic drugs "

October 14, 2009 -- (Washington, D.C.) - U.S. Senators Jeanne Shaheen (D-NH) and David Vitter (R-LA) today introduced legislation to provide patients with faster access to affordable prescription drugs. The bipartisan Access to Affordable Medicines Act would close a loophole some brand name drug companies exploit that needlessly and unfairly delays the entry of safe, lower-cost generic drugs to the consumer market.    » read more »

Interim data from European studies confirm that one dose of Panenza® or Humenza® pandemic influenza vaccines induces robust seroprotective antibody response in children and adults

Lyon, France – October 8, 2009 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that a single dose of influenza A (H1N1) 2009 monovalent vaccines, Panenza® (15 mcg dose, non-adjuvanted) or Humenza® (3.8 mcg dose, adjuvanted), administered to children (3 years of age and older) and adults induces a robust immune response, according to results from clinical trials conducted in Europe.    » read more »