Topic:

Regulatory

Latest Headlines

Latest Headlines

U.S. Attorney asks Novo Nordisk about plant in Denmark

Novo Nordisk says the U.S. Attorney in Massachusetts has subpoenaed it for information about potential manufacturing issues at a plant in Kalundborg.

UPDATED: Sarepta plunges as CEO moves goal line on Duchenne MD drug downfield

Following a meeting with regulators in September, Sarepta spelled out a new set of data that the FDA is looking for in the application for its closely watched Duchenne muscular dystrophy drug eteplirsen, and the biotech says it will have to delay filing--another dramatic turning point for the company this year, which saw its shares plunge 30% on the news this morning.

Merck grabs another 'breakthrough' in PD-1 lung cancer race with Bristol-Myers

With the goal line for lung cancer in sight at the FDA as it races with an ambitious R&D team at Bristol-Myers Squibb, Merck has grabbed bragging rights to the agency's breakthrough drug designation for the checkpoint inhibitor pembrolizumab (Keytruda) for that golden market opportunity.

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.