Topic:

Regulatory

Latest Headlines

Latest Headlines

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. 

Ranbaxy bid to regain marketing approval for key generics shot down by federal judge

A Ranbaxy Laboratories effort to have two of its drugs returned to the U.S. FDA's marketing-approval list was quashed when a U.S. district judge dismissed the suit at the request of the agency.

Japan's PAFSC puts off decision on new Xarelto indication approval

A decision on whether to recommend approval of an additional indication for Bayer Yakuhin's anticoagulant Xarelto (rivaroxaban) has been put on hold by Japan's Pharmaceutical Affairs and Food Sanitation Council.

Amarin grants Eddingpharm Greater China rights to Vascepa with clinical trial needed

China's Eddingpharm has been granted rights by Amarin to sell hypertriglyceridemia drug Vascepa icosapent ethyl in Greater China.

UPDATED: FDA approves Actavis intrauterine device to prevent pregnancy

Actavis announced FDA approval of its drug delivering intrauterine device, Liletta, as a form of reversible contraception.