LONDON – The pressure on Actelion Ltd. is intensifying after a U.S. jury said the company should pay out $547 million in its license dispute with Asahi Kasei Pharma Corp of Tokyo. Read More
Back in June 2006, the FDA launched a formal initiative to get unapproved drugs off the market. That seems like a laudable goal. Over the years there have been some notable cases of unapproved products that resulted in injury or death. A high potency vitamin E injection called E-Ferol used to prevent blindness in premature infants, for instance, resulted in an estimated 40 deaths before it was yanked in 1983. Unapproved formulations of quinine used off-label for leg cramps resulted in 93 deaths before being banned in 2006. But while keeping dangerous medicines from the public is the core of the FDA's mission, some of the negative consequences of that effort have been on display over the last month . . . and served to further tarnish the industry in the eyes of the public. Read More
Concert Pharmaceuticals Inc., of Lexington, Mass., presented preclinical data showing C-10068 has activity in models of epilepsy, neuroprotection and neuropathic pain. The drug showed anti-convulsant activity in models of both grand mal and partial seizures, and it inhibited hippocampal neurotoxicity and demonstrated neuroprotective effects. The data were presented at the Antiepileptic Drug Trials XI Conference. Read More
Agile Therapeutics Inc., of Princeton, N.J., presented and published Phase II data showing that AG200-15 delivers a daily estrogen dose of 30 mcg, is well tolerated and did not cause differences in ovulation in obese vs. nonobese women. The data were presented at the American College of Obstetricians and Gynecologists' 59th Annual Clinical Meeting and published in the journal Hormone Molecular Biology and Clinical Investigation. Read More
Marshall Edwards Inc., of San Diego, expects to gross about $4 million through the private placement of common stock and warrants. The company said that about $1.1 million would result from the sale of 835,217 shares of common stock at $1.33 per share and the remaining $2.9 million would be subject to the exercise of one-year series B warrants at their initial exercise price of $1.33 per share and the fulfillment or waiver of certain conditions. Read More
Jerusalem's Teva Pharmaceutical Industries Ltd., announced this morning that it will acquire Frazer, Pa.-based Cephalon Inc. for $6.8 billion in cash, trumping Valeant Pharmaceutical International Inc.'s recent hostile bid of $5.7 billion. Read More
SAN FRANCISCO – Chatter in the biotech-sphere over the past year has centered on the current economic environment, health care pricing pressure and the fallout from large-scale acquisitions, all of which have converged to make business development a challenging mission, to say the least. Read More
