Topic:

Regulatory

Latest Headlines

Latest Headlines

NICE sings a different tune for Bayer's prostate cancer drug Xofigo

Bayer has had a tough time winning approval from U.K. cost-effectiveness gatekeepers for its prostate cancer therapy Xofigo. Now, the company is celebrating a bright point for Xofigo as NICE changed its tune and backed the drug for certain patients.

FDA says Sanofi and Regeneron's cardio contender looks approvable. But for whom?

A potential blockbuster from Sanofi and Regeneron has proven its ability to slash rates of cholesterol, the FDA said, but questions remain on just how widely the treatment should be used.

India fleshes out manufacturing cluster program to cut Chinese imports

India's plans to boost domestic drug manufacturing and cut reliance on imports from China could include a 15-year tax holiday, low-cost space at industrial parks and subsidies on interest owed to banks, according to  Bloomberg TV India.

Nasdaq-listed CASI flags carcinoma PhII for ENMD-2076 in China

Nasdaq-listed CASI Pharmaceuticals filed a China FDA application to conduct a Phase II clinical trial in fibrolamellar carcinoma patients for proprietary drug candidate, ENMD-2076.

Mindray management $30/share offer seen as opening gambit

As has been widely speculated, senior managers at NYSE-listed China devicemaker Mindray Medical offered $30 a share to take the company private, setting a line in the sand that punters think will be crossed.

Fujifilm, Pentax Medical swept up in U.S. DOJ subpoenas on duodenoscopes

Two more Japanese manufacturers of specialized medical scopes linked to a "superbug" outbreak were subpoenaed by the U.S. Department of Justice (DOJ) this week, reports said, as Olympus already faces related regulatory scrutiny and lawsuits.

FDA advisers back an approval for Sprout's twice-rejected female libido drug flibanserin

An FDA advisory committee has given Sprout Pharmaceuticals a thumbs up on its quest to gain the first approval ever for an experimental therapy designed to heighten women's sexual desire--but the panelists also want some postapproval studies to help clarify the safety issues involved.

FDA launches safety investigation of controversial raw foods for pets

In the wake of recalls of raw foods marketed to dog and cat owners, the FDA has started collecting samples of the products to test them for the pathogens Salmonella, Listeria, and E. coli. The samples will be collected from retail stores and will include frozen, freeze-dried, and dehydrated raw foods marketed for pets, according to a notice issued by the agency.

Sanofi bags 'breakthrough' tag for new Genzyme rare disease med

Sanofi's rare disease-focused unit Genzyme picked up the FDA's coveted breakthrough-therapy designation for a drug designed to treat a form of Niemann-Pick disease.

Sanofi snags a 'breakthrough' tag for a new rare disease drug

Sanofi's rare disease-focused Genzyme picked up the FDA's coveted breakthrough-therapy designation for a candidate designed to treat a form of Niemann-Pick disease.