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's pipeline could use a big approval, and it may have one coming in palbociclib.
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 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.
Gilead Sciences picked up a much-anticipated FDA approval for Harvoni, a combination therapy for hepatitis C that promises to cure the majority of patients without the need for painful injections that have plagued patients for years.
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 now has something that diagnostics companies find increasingly hard to obtain: Medicare coverage, obtained for its new cutting-edge colorectal cancer-screening test.
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.
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 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.