The U.S. Food and Drug Administration said that a generic version of the popular antidepressant Wellbutrin XL 300 mg, made by Impax Laboratories and marketed by Teva Pharmaceuticals as Budeprion XL 300 mg, is not therapeutically equivalent to the brand name drug. Teva has stopped further shipments of the product. FDA has approved five generic versions of Wellbutrin XL 300 mg. Each of the generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product. FDA has since determined that that approach is no longer appropriate and is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.

The Medicines Company has terminated a mid-stage dose-ranging study of its protease inhibitor, MDCO-2010, due to serious unexpected patient safety issues encountered during the trial. The company had been hoping to develop MDCO-2010 as in intravenous antifibrinolytic drug for the reduction of blood loss during surgeries. Although the cause of the safety issues and any potential link to the experimental drug are still under investigation, the company has stopped further development of MDCO-2010.

Sweden’s BioInvest International has announced further job cuts as part of its decision to focus on its oncology unit. Over the summer the company reduced its staff to 68 employees following the failure of TB-402, its experimental long acting anticoagulant in a mid-stage trial. Now, the company has announced an additional 20 jobs will be slashed, leaving the company with a staff of just 48, 39 of whom will work in research and development. The new job cuts will mean that BioInvest’s expenses next year will be reduced to around $11.4 million (approximately $75 million Swedish Kroner). BioInvest’s CEO, Svein Mathisen said, “we are moving from being an active member in a number of medical areas to focusing primarily on cancer”, with drugs such as BI-505, currently in early-stage trials for the treatment for multiple myeloma and two new preclinical drug cancer candidates expected to start development in the summer of 2013.

ArQule and Daiichi Sankyo announced that an independent data monitoring committee investigating their late-stage lung cancer trial on ARQ 197 recommended that the study be stopped early when it concluded that study would not meet its primary endpoint of improved overall survival. The trial had intended to test the efficacy of ARQ 197 plus Erlotinib versus Erlotinib plus placebo. Although the interim analysis showed a statistically significant improvement in progression-free survival, the benefit did not carry over to overall survival. “We are disappointed that the trial did not provide statistically significant results of overall survival in a disease and treatment setting which remains a major unmet medical need,” said Paulo Pucci, CEO of ArQule.

Celgene’s combination therapy, Revlimid with a chemotherapy regimen, led to greater toxicity and worse survival in patients with untreated castration-resistant prostate cancer. Men randomized to a regimen of Revlimid, docetaxel, and prednisone, had a 53 percent increased mortality hazard, a 32 percent greater risk for progression, and a significantly higher rate of non-hematologic adverse events. Revlimid’s poor performance may have been attributed to shorter treatment duration, lower dose intensity of docetaxel, and earlier treatment discontinuation. Daniel Petrylak, of Yale Cancer Center, said that “further analysis of the data is underway to help elucidate the observed results” in the Revlimid arm.