Topic:

Regulatory

Latest Headlines

Latest Headlines

Gilead's hep C combo Harvoni wins NICE blessing at $58K price

The U.K.'s cost-effectiveness watchdogs gave a thumbs up to Gilead Sciences' combo hepatitis C pill Harvoni, despite its £39,000 price, or about $58,000. The pill combines Gilead's new blockbuster hep C drug Sovaldi with another antiviral, ledipasvir, and has delivered impressive cure rates.

Novartis CEO: We can rebuild our good name after 'reputational hit' in Japan

What's going to save Novartis' reputation in Japan? Science, says CEO Joe Jimenez, a week after the government suspended his Japanese unit for failure to report side effects.

Boehringer takes pole position with its 'breakthrough' anti-anticoagulant

Boehringer Ingelheim submitted U.S., European and Canadian applications for an antidote to its own Pradaxa, leading the way among companies developing treatments that reverse the effects of blockbuster next-generation anticoagulants.

FDA requires new labeling on insulin pens to ward off spread of infections

The FDA is taking action to ensure that multidose insulin pens do not spread diseases by requiring the injectable devices to display the warning "For single patient use only."

Three Japanese device firms slapped with U.S. FDA queries on possible 'superbug' link

Three Japanese companies known more for their cameras than medical devices have been called on the U.S. FDA carpet to explain why their medical scopes may be associated with at least two "superbug" deaths.

Chinese business newspaper alleges kickback scheme among distributors for Siemens products

If the records of distributors of health-care equipment in China were used as an indicator, Germany's Siemens made well in excess of $50 million more in sales in the country than the company's own records showed.

Singapore's TauRx notes Alzheimer's candidate journal publication, but buzz eludes

Phase II results of the first clinical trial of a tau aggregation inhibitor for Alzheimer's disease were published last month in the Journal of Alzheimer's Disease, with Singapore-based TauRx Pharmaceuticals saying it was an important milestone as it moves to report top line results from a Phase III study in 2016.

MSK and Atara snag an FDA 'breakthrough' tag for T cell project

Memorial Sloan Kettering Cancer Center picked up the FDA's coveted breakthrough-therapy designation for a promising T cell therapy, working with partner Atara Biotherapeutics to get it on the market for patients with complications tied to bone marrow transplants.

Deadly flu outbreak in Hong Kong gathers pace, prompting vaccination push

Hong Kong health authorities now count at least 306 deaths from seasonal influenza this year, surpassing the 299 deaths attributed to the 2003 outbreak of SARS that echoed around the world, prompting a new vaccination push.

China moves to centralize drug purchases by hospitals to curb kickbacks to doctors

China's government issued new guidelines to centralize hospital procurements of all medicines by requiring them to obtain them only through provincial governments.