Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Vesiflo gets regulatory green light to market replaceable urinary prosthesis device for women

In a regulatory win, Washington's Vesiflo got an FDA green light to market its replaceable urinary prosthesis for female adults with bladder drainage problems.

FDA cracks down on Little City Dogs' compounded copies of popular pet meds

Turns out it's not exactly legal for pharmacies like Little City Dogs to mass-market cheap copies of veterinary drugs like Capstar, which is made by Novartis Animal Health. Now the FDA has informed the company of the violation, via a harshly worded letter the agency posted recently on its website.

AstraZeneca's $2B cancer contender lines up for EU scrutiny

AstraZeneca is expecting word from European regulators next week on whether they'll recommend approval for its new ovarian cancer treatment, a drug the company hopes can bring in $2 billion a year at its peak.

Age-related macular degeneration device wins FDA approval in patients aged 65+

The FDA approved VisionCare Ophthalmic Technologies' Implantable Miniature Telescope in patients with bilateral end-stage age-related macular degeneration aged 65 or older, the company announced today.

Eisai wins FDA nod for a drug to treat chemo-caused nausea

Eisai and partner Helsinn secured the FDA's blessing to market Akynzeo, a combination treatment designed to prevent nasuea and vomiting among cancer patients undergoing chemotherapy.