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.
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 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 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.
The FDA's crackdown on manufacturing plants has triggered German drugs packaging firm Gerresheimer AG to trim its financial outlook.
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.
Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis.
MonoSol Rx announced that the U.S. Patent and Trademark Office will decide by August 2015 whether BioDelivery Sciences International's BEMA drug delivery technology infringes on a patent protecting its Suboxone sublingual film.