Vir’s hepatitis B combo falls short in Phase II trial
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Clinical Trials Arena
Precision reports initial outcomes from Hepatitis B trial of PBGENE-HBV
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Precision BioSciences has reported initial outcomes from the ELIMINATE-B trial of PBGENE-HBV, a gene editing programme for treating chronic Hepatitis B patients who are HBeAg-negative.
Source
Clinical Trials Arena
SCG’s HBV T-cell therapy shows promise in Phase I trial
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SCG has revealed late-breaking data outcomes from the Phase I clinical trial of autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR-T) therapy, SCG101.
The therapy, which targets hepatitis B surface antigen (HBsAg), showed substantial antiviral activity in individuals with advanced HBV-related hepatocellular carcinoma (HBV-HCC).
Source
Clinical Trials Arena
VBI Vaccines recalls hepatitis B shot as it winds down operations
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Months after filing for bankruptcy, VBI Vaccines is taking the next step in shuttering operations with the voluntarily withdrawal of its hepatitis B vaccine, PreHevbrio.
The company alerted healthcare providers and the FDA that it would be looking to pull PreHevbrio last month.
Source
Fierce Pharma
Barinthus lays off 25% of staff, sidelines prostate cancer program to stretch out cash
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Barinthus Biotherapeutics has used positive interim data from a pair of phase 2 trials for its hepatitis B therapy as justification for sidelining its prostate cancer candidate and jettisoning a quarter of the T-cell-focused biotech’s workforce.
Source
Fierce Biotech
FDA declines expanded use of Dynavax's hepatitis B vaccine on insufficient data
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The U.S. drug regulator has declined to approve expanded use of Dynavax Technologies' (DVAX.O) hepatitis B vaccine in a section of patients, citing insufficient data over destruction of some trial documents, the company said on Tuesday.
Source
Reuters
FDA approves Gilead's Vemlidy drug for children with hepatitis B
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Gilead Sciences Inc . (NASDAQ: NASDAQ:GILD) announced the U.S. Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide) 25 mg tablets for the treatment of chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.
Source
Investing.com
Altimmune bails on hepatitis B after phase 2 data disappoint, quashing partnering plans
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Altimmune has been beaten by hepatitis B. The drug candidate, which the company was preparing for partnering, failed to meet the bar for further development in a phase 2 study, prompting the biotech to stop development and focus on its GLP-1/glucagon dual receptor agonist.
Source
Fierce Biotech
Assembly Bio to launch four infectious disease trials in 2024
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US-based biopharma Assembly Bio is planning to launch four clinical trials for its infectious disease pipeline candidates this year.
Assembly Bio CEO Jason Okazaki said the company hopes to initiate two trials in H1 and two in H2, focusing on herpes simplex virus 2 (HSV2), hepatitis B and hepatitis D (HDV).
Source
Clinical Trials Arena
FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen
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GSK’s antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, will get a rapid six-month review from the FDA when it is filed for approval, said the drugmaker this morning.
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Pharmaphorum