Communication missteps, overreliance on a contract research organization and lack of clarity of U.S. FDA expectations for an expanded access protocol for emergency use resulted in a warning letter posted June 18 that highlights potential pitfalls for sponsor/investigators conducting the individualized studies.
Aprilbio Co. Ltd. saw its stock surge 30% June 20 after announcing a potential $475 million (₩655.88 billion) deal with Evommune Inc. for autoimmune disease drug candidate APB-R3.
It appears that the expression no news is good news is especially applicable to intra-aortic balloon pumps (IABPs), thus the class I recall of Arrow International devices was bad news for patients.
Scientists spread across Europe and the U.S. filed for protection of an implantable electrode array including a plurality of microneedles, which may be implanted into the auditory nerve bundle and stimulate the auditory nerve in response to receiving electrical signals representative of observed sounds.
Sarepta Therapeutics Inc. CEO Douglas Ingram said he expects “ferocious” demand for gene therapy Elevidys (delandistrogene moxeparvovec), granted full approval by the U.S. FDA for Duchenne muscular dystrophy (DMD). Shares of the Cambridge, Mass.-based firm closed June 21 at $16.72, up $37.22, or about 30% on the news.
Alzheon Inc. has raised $100 million in a series E financing round to push its oral drug candidate for early Alzheimer’s disease (AD), ALZ-801 (valiltramiprosate), through a late-stage, Apolloe4 study.
Quoted biotech investor Syncona Ltd. is still struggling with the fallout from one of the worst bear markets on record, reporting its net asset value fell from £1.25 billion (US$1.58 billion) to £1.24 billion in its 2023-24 financial results on June 20. That is despite a restructuring toward more mature companies, with 70% of the portfolio now invested in clinical-stage assets.
Now that it has some experience with interchangeable biosimilars under its belt, the U.S. FDA is proposing an update to its interchangeability guidance that could eliminate the need for switching studies in some instances.
The U.S. CMS has floated an alternative payment model dubbed the Transforming Episode Accountability Model for Medicare beneficiaries in fee-for-service care, but some in industry have misgivings about the proposal.
Dexcom Inc. and Insulet Corp. both reported introductions of their products into new countries on the eve of the 2024 American Diabetes Association annual meeting in Orlando, Fla. The two firms also announced the U.S. launch of Insulet’s Omnipod 5 tubeless automated insulin delivery system with connectivity to Dexcom’s G7, the company’s latest generation continuous glucose monitor.
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