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.
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.
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 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.
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.
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.
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.
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 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.
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.