In a desperate attempt to control the ongoing Ebola outbreak in West Africa, the World Health Organization is appealing to drug companies and international regulatory bodies to work together to get experimental therapies and vaccines out of the lab and into the clinic as soon as possible.
The treatment, under review at the FDA, was acquired by Bristol-Myers Squibb as part of its $5.3 billion acquisition of Amylin last year and swiftly partnered with AstraZeneca in an extension of their 2007 diabetes pact.
The budget cuts required by sequestration may have added a big question mark to every FDA deadline on the schedule, but there are four big developers holding their breath right now in anticipation of a formal marketing decision on their experimental drugs.
A total of 436 Indians lost their lives during clinical trials sponsored in the subcontinent last year, according to government officials.
A new report from a top biopharma analyst at Bernstein Research maps out an alarming slide in clinical trial success rates in recent years.
Geron jumped in trading on Thursday after a report in Seeking Alpha about the biotech company's potential to have a breakout year with its experimental cancer drugs. Some investors swoon for volatile biotech stocks with the potential for major gains, and the Menlo Park, CA-based outfit's shares were up about 15% yesterday and traded at around $2 per share.
The drug giant's quick work with the experimental drugs shows how fast a company can get to a new drug application with treatments for well-defined groups of patients and impressive clinical data.
MPM Capital, New Enterprise Associates and Third Rock Ventures all chipped in on the $25 million round, with some additional help from the French biotech Ipsen--which contributed the company's two metabolic drug programs for the launch. Rhythm has now raised an impressive $65 million in venture funds.
Merck unveiled a full slate of Phase III data on its experimental sleep drug suvorexant, claiming a success in safely promoting a good night's rest among patients suffering from insomnia. And the pharma giant's team leader on the project says the late-stage results pave the way for an NDA later this year on one of the biggest late-stage drug prospects in its pipeline.
Hit with a pair of pipeline setbacks recently, Chelsea Therapeutics has opted to reduce worker pay and cut compensation for its top brass to extend its cash runway and fuel development of its experimental drug Northera.