The consumer group Public Citizen, in a petition to the U.S. Food and Drug Administration, said new research shows that Abbott’s popular weight-loss drug Meridia should be pulled from the market because of risks. The group says the drug has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients getting the drug. This is Public Citizen’s second petition to have Meridia banned. The FDA rejected the first petition four years ago, saying it was awaiting results of an ongoing trial. The group says the results are in, and they show that the drug’s dangers significantly outweigh its benefits. Public Citizen calculates that there have been 84 post-approval cardiovascular deaths of patients taking Meridia. This includes 32 patients who were 50 or younger and 11 patients 30 or younger. The group says about 294,000 prescriptions for Meridia were filled in the past 12 months.

 

Sanofi-Aventis is cutting up to 1,500 sales jobs, according to press reports. Sales reps were told to stay home on the Monday following Thanksgiving for a phone call that would notify them as to whether or not they had been laid off. Sanofi has not stated publicly how many positions are being cut. Sanofi-Aventis, like other major pharmaceutical companies, is facing increased competition from generic drug manufacturers as key patents are expiring.

The U.S. Food and Drug Administration notified Theravance that it would not approve the company’s antibiotic telavancin for the treatment of nosocomial pneumonia. The drug, marketed under the brand name Vibativ, is approved in the United States and Canada for the treatment of adult patients with complicated skin and skin structure infections caused by certain Gram-positive microorganisms. In a letter to the company, the FDA said it wanted Theravance to submit additional data and analyses to demonstrate the safety and efficacy of telavancin. The FDA also requested further rationale for the pooling of the data from the two telavancin studies, and noted the need for a pediatric drug development plan for the nosocomial pneumonia indication, and a customary safety update. If the additional data and analyses that Theravance submits to the FDA are deemed insufficient, the FDA may not approve the company’s application or may require that additional studies be conducted.

 

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, said that the U.S. Food and Drug Administration notified it that it would not accept its application to market its multiple sclerosis drug cladribine for patients with relapsing forms of the disease. EMD Serono said it plans to request a meeting with the FDA as soon as possible to discuss its comments on the application to begin marketing the drug and to reach an understanding on what would be required for the Cladribine Tablets application to be accepted for review.

 

Hemispherx Biopharma said that it received notification from the U. S. Food and Drug Administration that describes specific additional recommendations related to the company’s application for approval to market Ampligen, its treatment for chronic fatigue syndrome. The FDA determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx says it is carefully reviewing the FDA letter and will seek an expedited meeting with the agency to discuss its recommendations. The FDA stated that the two primary clinical studies submitted with the application did not provide credible evidence of efficacy of Ampligen. It recommends the company conduct at least one additional clinical study that shows a convincing effect and confirms safety in the target population. The FDA also commented on the need to resolve outstanding inspection issues at the facilities producing Ampligen.

 

Endo Pharmaceuticals said it received notification from the U.S. Food and Drug Administration that it would not approve its extended-duration testosterone undecanoate injection, AVEED, for men diagnosed with low testosterone or hypogonadism without additional information to address the agency's concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism. The letter also specified that the proposed Risk Evaluation and Mitigation Strategy is not sufficient. Endo said it is currently evaluating the FDA's complete response letter.

 

ZymoGenetics said it is cutting 52 positions, 15 percent of its workforce, and ending all new immunology research. These cuts follow the elimination of 161 positions in April when the company decided to stop its cancer research. According to a regulatory filing, cutting new immunology research will allow the company to focus on its only marketed product, Recothrom Thrombin, a treatment for surgical bleeding. It will also give the company more resources for developing and commercializing its pipeline of clinical and preclinical product candidates that have the most potential over the next three to four years. The restructuring will result in annual expense savings of $8 million to $10 million.