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Regulatory
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Hand holding elbow

Akeso scores China approval for ebdarokimab in plaque psoriasis

April 22, 2025
By Tamra Sami
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.
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No more ‘fox guarding the henhouse’ under new state PBM law

April 22, 2025
By Mari Serebrov
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.
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Neurology/psychiatric

FDA grants orphan drug designation to BA-102 for Phelan-McDermid syndrome

April 22, 2025
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.
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Robert Williamson, Triumvira CEO and Hernan Bazan South Rampart CEO

The BioWorld Insider podcast: Bracing for the impact of tariffs and grant cuts

April 22, 2025
By Lee Landenberger
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.
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Medtronic Simplera Sync and Minimed 780G pump system

Medtronic continues to close gap in diabetes tech

April 21, 2025
By Annette Boyle
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.
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Illustration of human body composed of molecules

Device makers wary of FDA guidance for AI-enabled software functions

April 21, 2025
By Mark McCarty
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.
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Product recall concept image

Q’apel Medical drops Hippo line of catheters after FDA warning

April 21, 2025
By Mark McCarty
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.
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Vykat XR
Biopharma regulatory actions and approvals March 2025

March FDA approvals beat prior months but NME pace stays slow

April 21, 2025
By Amanda Lanier
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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FDA sign

Makary’s vision for slimmed-down US FDA somewhat reassuring

April 21, 2025
By Mari Serebrov
Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda.
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Woman scratching hives on shoulder

Dupixent bounces back in treating hives with FDA approval

April 21, 2025
By Lee Landenberger
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
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