WASHINGTON – Regulatory uncertainty at the FDA is often cited as a source of industry heartburn. But rather than turning down the heat, the agency is looking for ways to make that uncertainty less irritating, recognizing it as a natural part of the scientific process.
Forma Therapeutics Inc.'s goose that lays the golden eggs just hatched one that could be worth about $815 million in a four-year drug discovery deal with Boehringer Ingelheim GmbH.
Essex Woodlands and Smith & Nephew plc welcomed the new year with a new idea that could launch the device maker into the drug world and create a trend for other life sciences companies and venture capitalists.
While the U.S. government is betting on biosimilars to cut health care costs, many small biotechs are staying away from the game because of the risks and high stakes. And big biopharma players are upping the ante with multimillion-dollar partnerships with generic drug makers in hopes of a big payout years from now.
If its start-up is an indication of things to come, the National Center for Advancing Translational Sciences (NCATS) will soon be speeding the development of new drugs.
WASHINGTON – It's a scenario that invokes all the imagery of blockbuster disaster movies. A terrorist attacks the U.S. with the deadly smallpox virus, causing pandemonium and chaos in a country where only people older than 40 are generally vaccinated against the disease.
WASHINGTON – A consent decree with the FDA and a potential $500 million settlement with the Department of Justice (DOJ) are the price Ranbaxy Laboratories Ltd. is paying to once again have complete access to the U.S. market.
