Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Pfizer breast cancer prospect grabs FDA's speedy review promise

Pfizer's pipeline could use a big approval, and it may have one coming in palbociclib.

Eisai adds to chemo side-effects franchise with FDA nod for Akynzeo

Months after launching a regulatory battle to extend exclusivity for two of its best-selling products, Eisai won FDA approval for its Akynzeo drug to treat common side effects in patients undergoing chemotherapy.

Pfizer nabs a fast FDA review for breast cancer pipeline star palbociclib

Pfizer has picked up a priority review designation for its closely watched cancer drug palbociclib, potentially slicing four months off the review timeline for a therapy that is being hustled along at an accelerated rate.