Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Boston Scientific wins CE mark for MRI-friendly pacemaker products

Boston Scientific won CE-mark approval for a new suite of MRI-friendly pacemaker products, boosting its product offerings and furthering its plan of revitalizing sales for its sluggish cardiac unit.

Repros plummets as the FDA deals a blow to its low-T hopes

After years of clinical and regulatory setbacks, Repros Therapeutics was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for the meeting and indefinitely delaying Repros' plans.

UPDATED: FDA panel say Pfizer's Chantix should continue to wear a 'black box' label

Pfizer's controversial smoking-cessation drug Chantix will continue to be stuck with a black-box warning label at least until late next year, assuming the U.S. Food and Drug Administration follows the recommendations of its experts.

Novartis' psoriasis drug looks good enough to approve, FDA staff says

The benefits of Novartis' new anti-inflammatory treatment outweigh its risks, according to FDA reviewers, an opinion that improves the odds of approval for a drug the company hopes can bring in blockbuster sales.