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