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.
Last month, the feds took issue with Bayer's marketing for its Phillips' Colon Health product, saying the company's claims lacked scientific backing. But the way the German pharma sees it, the legal standard the DOJ is holding it to is not only unfair, it's unprecedented.
What's a drugmaker hauled up for marketing violations to do? If you're Galderma, you declare yourself exempt from the rules.
Indian drugmaker IPCA, which has stopped shipping products to the U.S. and Canada from a plant in Bangalore, has acquired a high potency oral solid dosage facility from Alpa Laboratories.