The Alfred Mann Foundation (AMF) and Össur have signed an agreement that will allow Reykjavik, Iceland-based Össur to further develop and license the implanted myoelectric sensor (IMES) system developed by AMF. Both organizations expect clinical trials to begin within the year.

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.

Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said.

How vulnerable is the U.S. biopharma supply if China were to halt exports of active pharmaceutical ingredients (APIs)? No one knows. "We cannot assess the extent of U.S. dependence on China," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said in testimony to a House subcommittee Wednesday.

Deciding which patients should go into the intensive care unit (ICU) after surgery is a difficult call and typically made entirely at the surgeon's discretion. The result is that surgeons typically err on the side of caution by putting more post-operative patients in the ICU than necessary. To aid in better ICU decision-making, physicians at New York University Langone Hospital System (NYU Langone) developed a machine learning algorithm that combs through a patient's electronic medical record to identify relevant factors to determine if they needed the ICU after surgery.