As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable.
The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting challenges for regulators across the world.
DUBLIN – Beckley Psytech Ltd. raised $80 million in an oversubscribed series B round to move its early stage pipeline of psychedelic therapies into the clinic and to continue research on novel compounds with enhanced properties.
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
The FDA has made allowances for a third COVID-19 vaccine dose to protect certain adults with compromised immune systems. The amended emergency use authorization amendments allow for booster doses of mRNA vaccines from Pfizer Inc.-Biontech SE and Moderna Inc.
Reiterating prescription drug pricing provisions included in an executive order issued in July, U.S. President Joe Biden provided a bit of context and a little more detail about what he has in mind during a brief Aug. 12 speech on how his “Build Back Better” agenda would lower drug prices. Part of that agenda is to allow Medicare to directly negotiate prescription drug prices. “The only thing Medicare is not allowed to negotiate are prices for prescription drugs. My plan gets rid of that prohibition,” Biden said, adding that Medicare negotiates every other health care cost.
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago.
Pfizer Inc.’s voluntary recall of batches of Chantix (varenicline) in mid-July called attention to the smoking-cessation market, where the nicotinic acetylcholine receptor agonist holds lead position, with Glaxosmithkline plc’s Zyban (bupropion) – another oral prescription drug – also a contender. In line to potentially shake up the space with cytisinicline, a plant-based alkaloid, is Achieve Life Sciences Inc.
With generic competition on the horizon for its older sleep disorder drug Xyrem, Jazz Pharmaceuticals plc gained an added indication for its GABA B receptor agonist Xywav as the FDA approved it for idiopathic hypersomnia.
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