Pharmaceutical industry

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 »

Five Main Research Centers Will Drive Scientific Innovation

November 09, 2009 -- NEW YORK -- Pfizer Inc today announced its global research and development network, marking an important step in implementing a new R&D model as part of the integration of Pfizer and Wyeth. This global network brings together scientific strengths from both companies, continues efforts to increase research productivity, focuses disease-area research in single locations and more efficiently uses the company’s real estate.    » 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 »

11/09/2009 -- California Governor Arnold Schwarzenegger today issued the following statement applauding Pfizer’s announcement to include California in its global research and development (R&D) network:

“California has always been a leader in biotech research and innovation and Pfizer’s announcement that it will establish California as one the five hubs of its worldwide R&D network is fantastic news for our state. Today’s announcement will not only ensure that our state continues as a leader in this growing field, but it will also help stimulate our economy and save and create jobs when we need them most. With the best workforce and most innovative spirit, California continues to be the best place in the world to do business.”    » read more »

Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®)

09 November 2009, London UK -- GlaxoSmithKline (GSK) today announced the results from the clinical trial assessing Pandemrix™, GSK’s adjuvanted H1N1 pandemic influenza vaccine, administered at the same time as the annual seasonal influenza vaccine, Fluarix ® . The trial showed that co-administration of one dose of both vaccines in separate arms, induced a strong response in adults for both the H1N1 pandemic vaccine as well as the seasonal vaccine. The trial involves 168 adults aged over 60 years of age, and was designed to evaluate the tolerability and immunogenicity of the co-administration of Pandemrix and Fluarix.    » 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 »

Says FTC Investigation Of CVS/Caremark Merger Is Necessary To Ensure Fair Competition

November 6, 2009 -- (WASHINGTON, D.C.) – U.S. Senator Byron Dorgan (D-N.D.) today welcomed the news that the Federal Trade Commission is investigating the 2007 merger of CVS and Caremark, saying it is necessary to ensure fair competition in the prescription drug market.

In July, Senator Dorgan, along with Senators Russ Feingold (D-WI) and Amy Klobuchar (D-MN), sent a letter to the FTC stating that the combination of Caremark and CVS “created a heightened opportunity for anticompetitive conduct in the prescription drug market.” They requested that the FTC investigate the merger because it was hurting Main Street pharmacies.    » read more »

U.S. Also Files Complaint Against Two Atlanta-Based Nursing Home Chains and Their Principals

November 3, 2009 -- WASHINGTON — The nation’s largest nursing home pharmacy, Omnicare Inc. of Covington, Kentucky, will pay $98 million, and drug manufacturer, IVAX Pharmaceuticals of Weston, Florida, will pay $14 million to resolve allegations that Omnicare engaged in kickback schemes with several parties, including IVAX, the Justice Department announced today. Approximately $68.5 million of the settlement proceeds will go to the United States, while $43.5 million has been allocated to cover Medicaid program claims by participating states.    » read more »