Derma Sciences Inc., of Princeton, N.J., is taking an important step in development of a therapy for a tough indication – diabetic foot ulcer. It began enrolling patients in the first of two Phase III trials of its topical drug candidate, DSC127.
Higher-than-expected product sales pushed Gilead Sciences Inc.'s fourth-quarter earnings beyond the Street's expectations, according to the company's earnings report released Monday.
The FDA convened a public hearing to receive input on its proposal to expedite development of new drugs for serious or life-threatening conditions with unmet need. The pathway, which is being considered primarily for development of agents to combat antibiotic-resistant infections, would involve smaller, faster clinical trials with narrow, tightly enforced labeling for use in patients without other options.
NewLink Genetics Corp.'s HyperAcute technology will get a boost from a public offering of 4 million shares of common stock in the company priced at $11.40 per share, or net proceeds of $42.5 million.
Thirty-five million people in the U.S. suffer from a stubborn fungal infection of the nail and nail bed called onychomycosis. Patients are typically treated by debridement to improve the appearance of the nail, but options for actually eliminating the fungus are lacking.
With launch of its Phase III registration studies for Lupus drug blisibimod imminent, Anthera Pharmaceuticals Inc., of Hayward, Calif., priced an underwritten public offering worth $40 million in gross proceeds to support operations as it goes forward.
Biogen Idec Inc.'s peginterferon beta-1a produced a significant reduction in annualized relapse rate in patients with multiple sclerosis according to primary efficacy analysis from a Phase III study.
Celgene International Sarl, of Boudry, Switzerland, struck a blow against a notoriously difficult disease with positive overall survival results in a trial of Abraxane (nab-paclitaxel) in metastatic pancreatic cancer.
The FDA issued a complete response letter to Impax Pharmaceuticals, of Hayward, Calif., a division of Impax Laboratories Inc., for Rytary (IPX066), indicating that a re-inspection of the company's Hayward facility pursuant to a warning letter issued in May 2011 is necessary before the new drug application (NDA) may be approved.
Theravance Inc., of South San Francisco, will use proceeds of a $250 million aggregate principal amount of convertible subordinated notes due 2023 to make milestone payments to GlaxoSmithKline plc upon launch of products developed under the two companies' collaboration around long-acting beta 2 agonists (LABAs).
