Stephen Hahn, of the MD Anderson Cancer Center, generally managed to avoid any controversy in today’s Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem.
About two months ahead of the priority review action date, Novartis AG scored FDA clearance for Adakveo (crizanlizumab), previously known as SEG-101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients ages 16 and older with sickle cell disease (SCD).
Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020.
BEIJING Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance.
The fish were biting Tuesday at Amarin Corp., as the FDA released its briefing documents for Thursday's advisory committee review of a first-of-its-kind indication for the company's fish oil-based Vascepa.
Bowing to congressional pressure, the U.S. Department of Health and Human Services (HHS) Wednesday filed suit against Gilead Sciences Inc. for infringing government patents related to the use of HIV drugs Truvada and Descovy for pre-exposure prophylaxis (PrEP).
Whether prescription drug prices are skyrocketing in the U.S. is a question of perspective and context. Patients needing regular refills of insulin or certain other brand drugs with no generics are seeing their out-of-pocket costs going up, sometimes with every trip to the pharmacy.
Those cheap prescription drug prices other countries get? They're not always the result of savvy government negotiations. An antitrust suit the U.S. Court of Appeals for the Second Circuit dismissed Tuesday alleges that some of those low prices may be innovator shenanigans intended to prevent or delay biosimilar competition in the U.S. market.
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated.
How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.