Topic:

Regulatory

Latest Headlines

Latest Headlines

Prosensa heads to the FDA with its once-failed DMD treatment

Prosensa has begun the FDA submission process for its treatment for Duchenne muscular dystrophy, planning to fully file by year's end with hopes of finally winning approval for a drug that has survived a few brushes with failure.

Exact Sciences nails coveted Medicare coverage for colon cancer DNA test

Exact Sciences now has something that diagnostics companies find increasingly hard to obtain: Medicare coverage, obtained for its new cutting-edge colorectal cancer-screening test.

Report warns of cyberattacks against medical devices to extort money

Medical device cyber security concerns were aroused when a baddie in the show Homeland hacked into the vice president's pacemaker and initiated a fatal heart attack. Now, a report by the European Cybercrime Centre warns of the real rise of similar "ransomware" attacks, although financial gain, not murder, would be the goal.

PhRMA renews legal battle over big hospital discounts for orphan drugs

Last October, the Pharmaceutical Research and Manufacturers of America (PhRMA) sued the federal government over a rule that allowed some hospitals to get orphan drugs at a steep discount. At first, it looked like the trade group had prevailed, because in May, a federal court struck down the authority of the U.S. Health Resources and Services Administration (HRSA) to enforce the rule.

Amgen eyes a speedy approval for its leukemia contender

Amgen is angling for an early FDA nod for the leukemia treatment blinatumomab, racing to market with what the company hopes will be the first of many cancer therapies derived from its proprietary T cell platform.

Hillary Clinton hedges on the device tax, says nation must weigh pros and cons

In a speech emphasizing the importance of compromise, likely presidential candidate Hillary Clinton said that there may be room for that dirty word in Washington when it comes to repealing the 2.3% medical device tax. That is a key demand of Republicans, not to mention of the device industry.

Shire's long-delayed ADHD drug hits another FDA speed bump

Shire's plans to squeeze more sales out of its blockbuster Adderall franchise are facing another delay, as the FDA wants more data on a new long-acting ADHD treatment that has languished in agency purgatory for years.

Boston Scientific wins positive recommendation from FDA panel for stroke-fighting Watchman device

Boston Scientific won a positive recommendation from an FDA panel for its stroke-fighting Watchman device, even as panel members expressed doubt that the product would work well in patients who are eligible for traditional drug therapy.

Gerresheimer adjusts earnings forecast lower in wake of FDA crackdown

The FDA's crackdown on manufacturing plants has triggered German drugs packaging firm Gerresheimer AG to trim its financial outlook.

Chantix litigation may be wrapped, but safety debate wears on

Just as a federal judge says it's time to close the books on the Chantix litigation that's been moving through her Alabama court, Pfizer is preparing for another kind of fight over the drug. The company has been building its case for the FDA to clear the black-box warning off the stop-smoking drug's label, but patient groups are now petitioning the agency to add more heft to that warning instead.