Topic:

Regulatory

Latest Headlines

Latest Headlines

Eisai gets EMA nod for Lenvima just weeks after FDA approval

Eisai has gotten its second dose of good news in as many months. Weeks after getting an FDA approval for its thyroid cancer drug Lenvima, the struggling Japanese drugmaker has gotten the nod for the potential blockbuster by the European Medicines Agency (EMA).

Federal Trade Commission cracking down on questionable mobile medical apps

Although the FDA is taking a hands-off attitude toward regulating new forms of health information technology, the Federal Trade Commission has stepped up enforcement of those app makers that make false or misleading claims.

Japan's Otsuka sues U.S. FDA over Abilify in unique focus on exclusivity rules

Japan's Otsuka Pharmaceuticals accused the U.S. FDA in a unique court suit of manipulating its regulatory procedures to kill off its 7-year exclusivity to market Abilify (aripiprazole) for treating Tourette syndrome in children.

Japan's Olympus issues new cleaning instructions on duodenoscopes

Olympus issued new cleaning instructions to healthcare professionals to sterilize its duodenoscope blamed for an outbreak of the "superbug" in some hospitals, leading to at least two deaths.

Novo Nordisk speeds back to the FDA with its once-rejected insulin

After a surprise FDA rejection sent it back to the drawing board in 2013, Novo Nordisk is finally ready to resubmit Tresiba, a long-acting insulin with blockbuster potential.

Orexigen's Mysimba catches up to Saxenda at EMA finish line

Orexigen Therapeutics' obesity med, Mysimba, has Europe's green light as of Thursday. But it doesn't come without conditions.

The FDA's kinder, gentler attitude toward India hasn't stopped tough enforcement moves

The FDA may have been all smiles and pleasantries at a recent meeting with its counterparts in India, but that hasn't stopped it from taking serious action against the country's manufacturing plants.

Pleasantries aside, U.S. FDA keeps sharp eye on India pharma manufacturing

The exchange of niceties and promises of softness in recent meetings with India counterparts notwithstanding, the U.S. FDA continues to take harsh action against India drug-production plants. The latest is a ban on imports from two more Ipca Laboratories plants.

U.S.-based Chinese researcher pleads guilty in United Imaging Healthcare bribery case

One of three Chinese nationals charged with taking bribes from China's United Imaging Healthcare four years ago has copped a plea with federal prosecutors. Yudong Zhu, a Chinese citizen working at New York University, pleaded guilty to lying in a filing for a U.S. National Institutes of Health grant.

Indian state to train employees to think like FDA inspectors

Underwriters Laboratories will train 60 food-and-drug inspectors for India's Gujarat state government so that they begin to assess drug manufacturing plants in the same way that U.S. FDA inspectors do.