The European Association of Medical Device Notified Bodies inked a position paper on the EU Artificial Intelligence Act which recites some standing concerns. Perhaps the most interesting passage in the paper is that there is a need for a “well-coordinated approach between member states that are in charge of notified body oversight.”
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
China’s National Medical Products Administration has given the thumbs up to Akeso Pharmaceuticals Inc.’s ebdarokimab for treating moderate to severe plaque psoriasis in adults. An interleukin (IL)-12/IL-23 dual-targeted monoclonal antibody, ebdarokimab (also known as AK-101) is the company's first class 1 new drug approved for autoimmune diseases.
Tired of waiting for the U.S. Congress to get around to making meaningful reforms to pharmacy benefit manager (PBM) practices, states are beginning to take the matter into their own hands. Arkansas recently became the first state to pass a law stopping PBMs, their affiliates or their parent companies from acting as a "fox guarding the henhouse" by being both a price setter and price taker, as the legislation puts it.
Neuronos Ltd., a subsidiary of Beyond Air Inc., has announced BA-102 has been awarded U.S. orphan drug designation for the treatment of Phelan-McDermid syndrome.
As pharma deals with the impact of U.S. NIH grant cuts and the imposition of tariffs, a lot of pressure is shifting to smaller and midcap companies, according to two executives who spoke on the newest BioWorld Insider podcast.
Medtronic plc’s diabetes unit posted another win with the U.S. FDA approval of the Simplera continuous glucose monitoring sensor for use with the Minimed 780G pump system, helping the company catch up with competitors Abbott Laboratories and Dexcom Inc. Medtronic plans to begin a limited launch of the Simplera Sync in the U.S. this fall.
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.
U.S. FDA warning letters typically have a noticeable effect on device manufacturing operations, but in the case of Q’Apel Medical Inc., a warning letter led to the withdrawal of a product for which the company made changes that were not cleared by the agency.
The U.S. FDA cleared 21 drugs for market in March, topping 16 approvals granted in February and 12 in January. That brought the first quarter (Q1) total to 49 approvals, just one short of the 50 logged in Q1 2024, making it the second-highest Q1 count in BioWorld’s records.
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