Topic:

Regulatory

Latest Headlines

Latest Headlines

Smith & Nephew puts up $12M to clear the way for its $1.7B ArthroCare deal

Smith & Nephew, the U.K. orthopedic giant, has agreed to pay $12 million to settle a shareholder lawsuit blocking its $1.7 billion acquisition of ArthroCare, according to a SEC filing. 

Impax gives it another go with a once-rejected Parkinson's drug

After a manufacturing problem irked the FDA and scared off partner GlaxoSmithKline, Impax Laboratories is resubmitting its investigational drug for Parkinson's disease, hoping it can clear an agency inspection and finally get its treatment on the market.

Hamburg to PhRMA: If you don't have quality, the rest doesn't matter

A strong regulatory agency and the patient confidence it inspires are essential for both patients and the industry as a whole, Sanofi CEO Chris Viehbacher said Thursday. And while the FDA has made recent strides in restoring the patient trust the agency depends on, Commissioner Margaret Hamburg says it still has some work to do.

UPDATED: Celladon's heart drug grabs 'breakthrough' status at FDA

San Diego-based Celladon has nabbed a "breakthrough" drug designation from the FDA for its heart failure drug Mydicar. The gene therapy uses a benign virus to insert the Serca2a gene into heart cells.

French watchdogs raid Novartis, Roche in Lucentis antitrust probe

The French Competition Authority has stepped up its probe of potential Lucentis price-fixing. As The Times of London reports, the antitrust regulators said they raided local offices of Roche and Novartis, looking for evidence of collusion.

Sources: Sun has blueprint for turning Ranbaxy around

Sun Pharmaceutical execs acknowledge it will be no easy task to repair Ranbaxy Laboratories' damaged reputation with the FDA and the public. But Sun managing director Dilip Shanghvi and his lieutenants came in with a laundry list of actions to be taken quickly to jump-start the process, sources tell Reuters.

Colorado Senate hears vaccine bill testimony

Though the bill passed in the House after a bipartisan 42-19 vote, opponents have accused its sponsor of treating parents like "idiots" and "morons."

Indian authority withdraws Ranbaxy plant export permit

Indian authorities, who have been criticized for turning a blind eye to serious problems at Ranbaxy Laboratories plants there, have stopped a Ranbaxy API plant in Toansa from being able to sell products outside of India.

FDA drops a hold on Halozyme study

The latest news sliced only 3% off the biotech's share price.

Medtronic snags EU approval for an MRI-safe ICD

Medtronic is headed to the European market with what it says is the first implantable defibrillator cleared for full-body MRI scans, following a widespread trend toward imaging-safe implants.