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Gilead Submits BLA for Chronic Hepatitis Therapy
Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
Gilead Sciences has submitted a biologics license application (BLA) to the FDA for bulevirtide for injection, a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults. Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
The submission is supported by data from completed and ongoing phase 2 studies and the ongoing phase 3 MYR301 study, which supports the safety and efficacy of bulevirtide once daily after 24 weeks of therapy.
Interim results from the phase 3 MYR301 study indicate that after 24 weeks of therapy, the proportion of people with HDV infection achieving the combined virological and biochemical response was 36.7% with bulevirtide 2 mg, 28% in participants receiving bulevirtide 10 mg and 0% in participants currently under observation who have not received antiviral treatment at this stage of the study.
In Europe, Hepcludex (bulevirtide) has been granted conditional marketing authorization by the European Commission and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency, as the first approved treatment in Europe for adults with chronic HDV infection with compensated liver disease.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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