Topic:

Regulatory

Latest Headlines

Latest Headlines

The FDA has spoken on biosimilar names. But will its hybrid proposal work?

After much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. And it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy.

Sun faces class action suit over closure of Caraco plants 6 years ago

It has been more than 6 years since Caraco Pharmaceutical Laboratories was forced to suddenly shut two Detroit-area manufacturing plants after the FDA sent in marshals to seize drugs, claiming the plants had contamination issues. One of the plants was even closed last year by Caraco owner Sun Pharmaceutical. But legal problems continue to reverberate for Sun for having laid off hundreds of workers without notice.

Woodcock says FDA will keep new plant quality grades a secret

The FDA publishes warning letters and inspection reports on its websites. It issues public recalls and drug label warnings. However, it is not feeling in such a sharing mood when it comes to its proposed letter grades for manufacturing plants on the quality of their manufacturing.

India's Gujarat state moves closer to country's first medical device testing lab

A lab dedicated to biocompatibility and medical device testing to be based in India's western Gujarat state, a manufacturing hub, would mark a first and has received backing from the federal government with hopes of getting state officials to offer funds as well.

Oncology trials in China may see pilot program for 60-day IND decision

Investigational new drug applications for oncology in China may see a 60-day deadline for a thumbs up, or down, placing the country on a path already followed by Singapore, Taiwan and South Korea for quick early-stage decisions.

China's Shenzhen Hepalink keeps N. American deal stream rolling with Cytovance

In a continued stream of North American deal-making China's Shenzhen Hepalink Pharmaceutical bought U.S.-based biologics contract manufacturer Cytovance Biologics for $205.7 and unspecified contingency payments with plans to accelerate the target's expansion plans.

Post-approval interim data on ALS neurostim device confirms survival benefit

When the FDA approved the NeuRx Diaphragm Pacing System to treat chronic hypoventilation in amyotrophic lateral sclerosis (ALS) patients in September 2011 under the Humanitarian Device Exemption (HDE), the agency required an extensive post-marketing study. Now Synapse Biomedical, which markets the neurostimulator breathing device, has reported interim data from that study that's a bit better than the approval data.

Eli Lilly slaps down Teva's challenge to Alimta exclusivity

Eli Lilly has fought tooth and nail to protect a patent for its blockbuster cancer drug Alimta, chalking up some victories in the U.S. despite setbacks overseas. Now the company is celebrating a big win as a federal court ruled in its favor, granting Lilly 5 more years of Alimta exclusivity in the U.S.

White House urged to stop states' 'rationing' of hep C drugs

Hep C drugs like Gilead Sciences' Sovaldi and AbbVie's Viekira Pak can cure hepatitis C, preventing people from getting liver disease. But in some states like Illinois, a person on Medicaid can't get Sovaldi unless they already have advanced liver disease. Even then, other restrictions can block them from access to the pricey meds. This kind of rationing is to save money, not lives, and is discriminatory White House medical advisors have told the administration. Experts have urged a reluctant administration to lay down some consistent guidelines for Medicaid on use of the new drugs.

Sarepta snags priority review status to keep pace with BioMarin in DMD race

The FDA has awarded priority review status to Sarepta Therapeutics' eteplirsen. The regulatory go sign means Sarepta is still tucked in just behind BioMarin in the race to bring a therapy for Duchenne muscular dystrophy to market, with analysts tipping the agency to make a decision on both drugs by the end of the year.