Pfizer said it is discontinuing its late-stage study of the cancer drug figitumumab (CP-751,871) as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer because the study met predefined boundaries for early termination. An analysis by an independent Data Safety Monitoring Committee showed that the addition of figitumumab to paclitaxel pluscarboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The discontinuation follows a halt in new patient enrollment to the study in September 2009 when the Data Safety Monitoring Committee observed an apparent imbalance of certain serious adverse events between the treatment arms with more events, including fatalities, occurring in patients who were randomized to receive figitumumab.

San Diego-based Arena Pharmaceuticals said Merck notified the company it will discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis and end the collaboration under which it was being developed. Merck made the decision to discontinue development of MK-1903 following evaluation of the results of a recently completed Phase 2a clinical trial. According to Merck, elevation of HDL cholesterol relative to placebo did not meet the trial's pre-specified primary objective for efficacy. Arena said no safety signals were implicated as drivers of the decision to discontinue development.

Johnson & Johnson Pharmaceutical Research & Development said the U.S. Food and Drug Administration notified it that it would not approve its application to market ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections without additional information. The FDA has recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. The company said it intends to discuss the best path forward with the FDA as soon as possible. Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica in February 2005. In March 2008, the company received an Approvable Letter regarding the ceftobiprole filing.

Pfizer said that the U.S. Food and Drug Administration notified it that it would not approve its Lyrica capsules CV as a monotherapy treatment for generalized anxiety disorder. The FDA determined that the data contained in the company’s application were insufficient to support approval. The application was a resubmission in response to a “not-approvable” letter issued by the FDA in August 2004. The FDA continues to review a separate application for Lyrica as adjunctive therapy for the treatment of generalized anxiety disorder.

Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets because of reports from consumers of a moldy smell that can cause nausea and sickness, the Associated Press reported. The New Brunswick, New Jersey-based company is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap. Johnson & Johnson had recalled five lots last month after consumers complained of a mildew-like odor that triggered nausea, stomach pain, vomiting and diarrhea. Johnson & Johnson attributed the smell to trace amounts of a chemical believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials.

Trimeris said that Arigene has informed the company that it intends to terminate the tender offer for all of Trimeris’ outstanding shares of common stock because Arigene was unable to secure sufficient financing for the tender offer. Trimeris obtained payment of the $12 million reverse termination fee payable to Trimeris under the Merger Agreement. Trimeris is evaluating its other rights and remedies under the Merger Agreement given the present circumstances. Trimeris intends to continue to actively manage its operations so as to maximize cash flow attributable to its commercial product Fuzeon.