Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Court orders Indian drugmaker to destroy $11M worth of unapproved drugs

In May, the FDA sent U.S. marshals into a warehouse to seize $11 million worth of drugs, everything from ear drops to urea cream, from an Indian company that the agency said were unapproved. Now the company is going to have to destroy them all while the FDA watches.

InterMune and Boehringer win tandem FDA nods for 'breakthrough' lung drugs

InterMune and Boehringer Ingelheim have spent the last year or so jockeying for the spotlight with in-development treatments for a rare lung disease, hoping to take pole position upon reaching the market. Now, as the FDA has decided to approve both drugs at once, the two companies will set off from equal starting points in the race for dominance.

FDA grants a combo-med exclusivity wish. Why is that a problem?

What's two extra years of exclusivity worth? Enough to spark a legal fight. The FDA posted new guidance on its website Friday, awarding certain combo meds 5 years of exclusivity compared with the previous three. Drugmakers had lobbied for the change, but the timing--and the wording--are bound to be controversial.

Ex-Merck employee charged in biotech's latest insider trading scheme

This summer, as Merck inched closer and closer to its $3.9 billion buyout of Idenix Pharmaceuticals, one of the company's employees tipped off a friend that a deal was imminent, federal prosecutors say. With that information, the pair made hundreds of thousands of dollars on insider trades, according to the SEC, the latest scandal for an industry increasingly vulnerable to such manipulation.