Topic:

Regulatory

Latest Headlines

Latest Headlines

U.S. Attorney subpoenas Novo for info on Denmark plant

Denmark-based Novo Nordisk said on Friday that it had received a subpoena from a U.S. Attorney who wants some info about its manufacturing operations at a plant in Kalundborg. But the company said it really has no idea why.

Baxter wins FDA approval for another hemophilia drug

Baxter widened its hemophilia franchise on the eve of its breakup, winning FDA approval for a drug that treats a rare form of the bleeding disorder.

EMA favors AstraZeneca's ovarian cancer drug Lynparza that FDA committee dissed

An FDA committee of experts this summer voted overwhelmingly against approval of AstraZeneca's new ovarian cancer treatment. But reviewers for the EMA gave it a nod for use on patients with platinum-sensitive ovarian cancer and BRCA mutations, FierceBiotech reports.

AstraZeneca gets some EU encouragement for its $2B cancer hopeful

European regulators have recommended an early approval for AstraZeneca's new ovarian cancer treatment, welcome news for the company as it defends rosy sales estimates for its oncology pipeline.

NPS Pharma will have to wait another three months for an FDA OK

The FDA has postponed its final decision on an orphan drug from NPS Pharma, taking its time with the company's application and delaying the fate of a closely watched therapy.

U.K. watchdogs back Bayer's Xarelto for heart attack patients

Bayer's Xarelto, which has been cruising along since it joined a new class of warfarin replacement therapies on the market, has faced a rare stumbling block in acute coronary syndrome--an indication the FDA has denied it on three separate occasions. But across the pond, it's picked up a nod in some ACS patients from the U.K.'s cost-effectiveness gatekeeper.

Industry faces new effort to make it pay for drug disposal

The U.S. biopharma industry has been battling a drug take-back law in Alameda County, CA, for several years, concerned that if it is approved, other jurisdictions would start asking them to pay for drug disposal. That law was upheld by a federal court, and now San Francisco is looking to the industry to pay the full cost of its drug-disposal law.

Boston Scientific upbeat on Watchman approval for 1H15, pegs 'conservative' $500M market

Boston Scientific expects an FDA approval of its controversial stroke-fighting device Watchman during the first half of next year coming off its third positive FDA panel, despite a checkered regulatory past that includes a 2010 rejection due to safety concerns.

UPDATED: Vertex's Kalydeco scores FDA panel rec in R117H. Are bigger nods next?

Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.

FDA clears app to monitor brain health on the battlefield

Reaction time can be a sign of brain injuries that are common on the battlefield such as concussion, dementia, post-traumatic stress and depression, says product developer AnthroTronix.