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.

Watson Pharmaceuticals Inc. has signed on to ride shotgun as Amgen Inc. prepares to hit the biosimilar road.

Advancing its third molecule to treat schizophrenia into a Phase III trial, Alkermes plc is zeroing in on the $4 billion Abilify market.

WASHINGTON – An annual development fee may be necessary to get the biosimilar pathway up and running, but it should be considered a stopgap measure that will end once the route is established, industry representatives told the FDA.

WASHINGTON – An FDA advisory committee faced some stark what-ifs this week in developing a treatment for a disease that no longer exists in the natural world.

An FDA advisory committee this week gave a half-hearted vote of approval – 9-8, with two abstentions – for Alexza Pharmaceuticals Inc.’s Adasuve (Staccato loxapine). But the vote was conditioned on limiting the inhaled antipsychotic to one dose per day and imposing a much stiffer REMS than what the company had proposed. While Alexza didn’t feel that much love from the Psychopharmacologic Drugs Advisory Committee (PDAC), it did get enough to bolster its flailing shares and keep hope alive for FDA approval come the Feb. 4 PDUFA date. A day after the lackluster committee performance, Alexza (NASDAQ:ALXA) hit $1, a...

The Psychopharmacologic Drugs Advisory Committee (PDAC) was not playing the tune Alexza Pharmaceuticals Inc. wanted to hear Monday as the committee tried to harmonize safety concerns for Adasuve with its benefits in treating acute agitation in patients with schizophrenia or bipolar disorder.