Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Glenmark on yo-yo string sales journey with diabetes generics in U.S.

Glenmark's marketing of a couple of diabetes generics in the United States continues to fluctuate like a yo-yo on a string. Now the India drugmaker can return the drugs to market until April 28.

Sanofi continues pediatric vaccine push with FDA Quadracel nod

Sanofi Pasteur counts pediatric vaccines among its 5 key areas, and it's bolstering its offerings in the field with Wednesday's FDA approval of the Quadracel vaccine.

Deal done, Sun Pharma must now fix Ranbaxy's deep problems

Sun Pharma will start on the hard work now that it has closed on its $4 billion merger of Ranbaxy Laboratories. Managing Director Dilip Shanghvi has pledged that it will get all four of Ranbaxy's sideline plants into 100% compliance with FDA requirements.

FDA bans two more IPCA plants

After issuing an import alert last year for an IPCA Laboratories API plant in India where employees had been falsifying drug testing results and deleting failed tests, the FDA began looking at its operations further upstream and has now banned products from two of IPCA's finished product facilities.