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A new class-action lawsuit from a terminal blood cancer patient claims that Celgene abused consumer safety regulations to monopolize cancer drugs. Read More
A federal jury awarded GlaxoSmithKline $235 million in a suit against Teva, saying the generics manufacturer infringed on GSK’s patent for the cardiovascular drug Coreg when Teva marketed its generic for chronic heart failure as well as high blood pressure. Read More
Two-thirds of the way through fiscal year 2017, the FDA has received at least 877 ANDAs, passing fiscal 2016’s total of 852 and beating fiscal 2015’s total by more than 330 applications. Read More
The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial drug resistance. Read More
The Congressional Budget Office officially scored the Senate bill reauthorizing the FDA’s user fee agreements, saying it would add $740 million to the budget and a negligible amount to the deficit over its five-year life. Read More
The House Energy and Commerce Committee voted unanimously to advance the FDA’s five-year user fee reauthorization package to the floor of the House — following a lengthy debate more on the rising cost of prescription drugs, than on the fee programs at the heart of the bill. Read More
The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the same year, according to the GAO. Read More
FDA Commissioner Scott Gottlieb outlined an action plan to remove barriers to generic competition, saying agency regulations have been “gamed” by brand-name manufacturers to delay generic drug approvals even after patents and exclusivity periods lapse. Read More