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US still awaiting first HDV drug after FDA hits Gilead’s Hepcludex with CRL

Oct. 28, 2022
By Jennifer Boggs and Michael Fitzhugh
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The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
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ODAC affirms briefing docs, votes down Y-mabs’ Omblastys

Oct. 28, 2022
By Randy Osborne
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Skeptical briefing documents pertaining to the U.S. FDA’s adcom meeting on Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) turned out predictive of the less-than-happy outcome, as the regulator’s Oncologic Drugs Advisory Committee (ODAC) turned thumbs down on the prospective drug for pediatric central nervous system/leptomeningeal metastasis from neuroblastoma.
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Regulatory actions for Oct. 28, 2022

Oct. 28, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avrobio, Diamedica, Dyadic International, ITM Isotope Technologies München, Myeloid, Novo Nordisk, Reveragen, Santhera, Simcere.
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FDA advisory panel says no to test for opioid use disorder

Oct. 27, 2022
By Mark McCarty
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A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.
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2022 Medtech Conference

Shuren floats voluntary alternative pathway for digital device premarket review

Oct. 27, 2022
By Mark McCarty
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Innovative medical devices are the norm for reviewers at the U.S. FDA’s Center for Devices and Radiological Health (CDRH), but regulatory innovation is a tougher climb. In response, CDRH director Jeff Shuren said at this year’s Medtech Conference in Boston that the agency is eyeing a voluntary alternative pathway (VAP) for novel digital technologies, although this concept is unlikely to see the regulatory light of day other than as a pilot program at any point in the next year or two, given the need for statutory authorization.
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Regulatory actions for Oct. 27, 2022

Oct. 27, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Astrazeneca, Beigene, Cellevolve, Cour, Hugel, Ipsen, Janssen, Novaccess, Petros, Seres.
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