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    Gastroenterology had a big year in 2022, with potentially game-changing FDA approvals for inflammatory bowel disease and several first-in-class therapies, yet the FDA’s rejection of the first hepatitis D therapy still looms large.Over the past year, the FDA has greenlit several notable additions to the gastroenterology armamentarium, including the first treatment for eosinophilic

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    • #Gastroenterology had a big year in 2022, with potentially game-changing @US_FDA approvals for #inflammatoryboweldisease and several first-in-class therapies, yet the #FDA’s rejection of the first #hepatitisD therapy still looms large #GITwitter https://t.co/8ezMu1Stsc

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    The Hepatitis B Foundation has awarded Stephen Urban, PhD, the 2023 Baruch S. Blumberg Prize for his development of bulevirtide, the first drug approved for the treatment of hepatitis D. “The entire hepatitis B/D community owes a tremendous debt to Dr. Urban for his conception, design and creation of new therapeutics for hepatitis B and D, as well as for his pioneering work on basic science

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    • . @HepBFoundation has awarded Stephen Urban, PhD, the 2023 Baruch S. Blumberg Prize for his development of #bulevirtide (@GileadSciences), the first drug approved for the treatment of #hepatitisD #MedTwitter https://t.co/2hZikvUX7r

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    The FDA issued a complete response letter to Gilead indicating it cannot approve the company’s new drug application that seeks approval of bulevirtide for chronic hepatitis D virus infection and compensated liver disease. In its letter, the FDA cited concerns over the manufacture and delivery of bulevirtide, a first-in-class investigational entry-inhibitor; however, no new studies to assess

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    • #ICYMI: @US_FDA rejects @GileadSciences’ #bulevirtide for #hepatitisD, compensated #liverdisease #FDA #GITwitter #MedTwitter https://t.co/k71mh8AR2k

  • Mashup Score: 0

    The FDA issued a complete response letter to Gilead indicating it cannot approve the company’s new drug application that seeks approval of bulevirtide for chronic hepatitis D virus infection and compensated liver disease. In its letter, the FDA cited concerns over the manufacture and delivery of bulevirtide, a first-in-class investigational entry-inhibitor; however, no new studies to assess

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    • The @US_FDA issued a complete response letter to @GileadSciences indicating it cannot approve the company’s new drug application that seeks approval of #bulevirtide for chronic #hepatitisD virus infection and compensated #liverdisease #FDA #GITwitter https://t.co/k71mh8AR2k

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    LONDON — Bulevirtide induced a greater combined virologic and biochemical response compared with control at 48 weeks in patients with chronic hepatitis D infection, according to research. “HDV causes the most severe form of chronic viral hepatitis with two-to-three-fold increased risk for mortality compared with HBV mono-infection,” Heiner Wedemeyer, PhD, professor and clinical

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    • #Bulevirtide induced a greater combined virologic and biochemical response compared with control at 48 weeks in patients with chronic #hepatitisD infection @EASLnews #ILC2022 #GITwitter #MedTwitter https://t.co/SdIdX2kUk6

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    Bulevirtide improved quality of life measures among patients treated for chronic hepatitis D virus, Maria Buti, MD, PhD, of the Hospital Universiario Valle Hebron, told Healio Gastroenterology. In a multicenter, randomized, phase 3 study, researchers evaluated the health-related quality of life benefits as measured by the Hepatitis Quality of Life Questionnaire (HQLQ) following 24 weeks of

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    • #Bulevirtide improved quality of life measures among patients treated for chronic #hepatitisD virus #NASPGHAN21 @NASPGHAN https://t.co/jugvKFOqWp