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news.FDA accepts cancer drug filing from Avantogen
As a result of the FDA decision a phase II study assessing RP101 combined with gemcitabine chemotherapy, versus gemcitabine chemotherapy alone, in patients with pancreatic cancer will proceed.
As a result of the FDA decision a phase II study assessing RP101 combined with gemcitabine chemotherapy, versus gemcitabine chemotherapy alone, in patients with pancreatic cancer will proceed.
The agreement will mean that drug manufacturers will have a clear framework to work with, which will allow trials to be initiated much faster. Previously trials could take
Under the terms of the agreement, Merck will acquire Sirna at a price of $13 per share in cash, making Sirna a wholly owned subsidiary of Merck. The
However, the company believes the trial provided the information necessary to proceed with development of the product. The primary endpoint was improvement in pain and urgency at the
The original complaints were filed in December 2002, and January, 2003, against Bio-Technology General Corporation, now known as Savient Pharmaceuticals, on behalf of investors who had purchased shares
The company also said that the drug was more successful at suppressing the virus when compared to Gilead Sciences’ rival hepatitis drug, Hespera. The viral suppression was seen
The phase III program of the Interleukin-1 (IL-1) Trap included two studies. Both studies met their primary endpoints, which was a reduction in disease activity. The activity was
The study was conducted at Oregon Health and Science University and Roswell Park Cancer Institute. Asentar is a new, high dose oral formulation of calcitriol, the most potent
The study evaluated the safety and efficacy of low and high fixed doses of oral insulin tablets versus placebo in patients with type 2 diabetes mellitus on existing
The opinion was provided at the request of a Spanish court that is hearing a patent infringement case filed against Pfizer by generic manufacturer Ranbaxy. The patent office