Topic:

Regulatory

Latest Headlines

Latest Headlines

Q&A: CMO says Covidien wants to engage parallel review process

FierceMedicalDevices caught up with Covidien Chief Medical Officer Dr. Michael Tarnoff at the annual AdvaMed conference in Chicago at the beginning of October. Tarnoff also performs minimally invasive and bariatric surgery part-time at Tufts Medical Center in Boston.

Novartis clears an FDA hurdle with its pioneering psoriasis treatment

A panel of FDA advisers voted unanimously in favor of approving Novartis' new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.

FDA accepts app for Merck, Sanofi 6-in-1 combo vaccine

Sanofi's Pentacel, which protects children against 5 serious diseases, nabbed the No. 3 spot on the world's list of best-selling vaccines last year. Whether an investigational 6-in-1 combo from the French drugmaker and partner Merck can eventually match its success remains to be seen, but the pair is now one step closer to finding out.

FDA will start the new year with its Office of Quality in place

The Office of Pharmaceutical Quality will finally open Jan. 1, and the FDA's Janet Woodcock will serve as its first acting director.

FDA approves Dexcom smartphone-enabled device for continuous glucose monitor

Dexcom won FDA approval for its next-generation mobile communications device for diabetes monitoring, chalking up another regulatory win and furthering the company's R&D push.

Canada cuts Apotex a break on some banned drugs

More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.

A glitch in bioequivalence software puts trial results in doubt

Observed glitches with Thermo Fisher's popular drug development software have led to concerns that data used to win approvals may have been faulty, and the company is working alongside regulators to figure out just how widespread the issue may be.

INC signs on to help Provectus get its regulatory act together

Provectus Biopharmaceuticals, a biotech that has been stung by regulatory setbacks, has recruited INC Research to audit its data on two drug candidates, tasking the CRO with poring over its documents as it moves into late-stage development.

Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts

Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the R117H mutation. But first, it'll have to get the FDA's OK, and new briefing documents suggest the agency still has some doubts.

Bristol-Myers catches a break as Indian agency delays Sprycel patent decision

Prime Minister Narendra Modi got an ear full from both constituents and the U.S. drug industry about India's approach to drug patents during his first visit to the U.S. last month. Three weeks later, there is evidence the government will take a considered approach to the contested issue.