The modest reduction in menopause-related vasomotor symptoms (VMS) recorded in three Phase III trials was not sufficient to warrant the side-effect risk associated with gabapentin, according to the FDA's Reproductive Health Drugs Advisory Committee, which voted 12-2 Monday to recommend against Depomed Inc.'s Sefelsa (formerly Serada). Read More
Their oral combo drug's 100 percent success rate in hepatitis C virus (HCV) patients with liver fibrosis did not do much for shares of Medivir AB and partner Gilead Sciences Inc., probably because the positive interim results from the Phase IIa trial were "baked in" by investors, who must wait to find out more. Read More
Celgene Corp. presented detailed results from its ESTEEM 1 Phase III trial of apremilast for psoriasis at the annual meeting of the American Academy of Dermatology in Miami. The trial met the threshold for statistical significance for its primary endpoint of 75 percent improvement in psoriasis area and severity index (PASI-75) at week 16 compared to placebo. Read More
LONDON – Ablynx NV raised €31.5 million (US$41 million) in a private placement, boosting cash reserves to around €90 million and allowing the company to progress development of its next-generation rheumatoid arthritis (RA) product ALX-0061 into Phase IIb, while negotiating with potential partners. Read More
• Merz North America, of Greensboro, N.C., reported on the ability of naftifine hydrochloride gel 2 percent to be both efficacious and tolerable in the treatment for interdigital-type and moccasin-type Tinea pedis. Read More
• Amicus Therapeutics Inc., of Cranbury, N.J., said it introduced chaperone-advanced replacement therapy (CHART) as the brand name for its technology platform that combines pharmacological chaperones with enzyme replacement therapy or lysosomal storage diseases. Read More
• Argos Therapeutics Inc., of Durham, N.C., said it validated the durability of the immune response for metastatic renal cell carcinoma patients treated with AGS-003. Read More
• Iroko Pharmaceuticals LLC, of Philadelphia, said the FDA accepted for review the new drug application (NDA) for lower-dose submicron diclofenac, a nonsteroidal anti-inflammatory drug, with a proposed indication of treatment of mild to moderate acute pain in adults. Read More
• Teva Pharmaceutical Industries Ltd., of Jerusalem, said results of a Phase III trial of Milprosa (progesterone) vaginal ring were published in Fertility and Sterility. Read More
