Gilead

GSK Receives FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B GSK plc has revealed that the US Food and Drug Administration (FDA) has awarded Fast Track status to bepirovirsen, an experimental antisense oligonucleotide (ASO) designed to treat chronic hepatitis B (CHB). Fast Track designation ai...

Gilead To Discontinue Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS Gilead Sciences, Inc. reported that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been halted due to futility based on a planned analysis. The safety data in this trial are consistent ...

FDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...

Gilead Buys Out Rights to Cancer Therapy from Jounce for USD 67 Million Gilead Sciences must have liked what it saw in a two-year-old collaboration with Jounce Therapeutics for CCR8-targeting cancer immunotherapy because the company has just agreed to own the program fully. The drug in question, GS-1811 (formerl...

GSK Acquires Sierra Oncology for USD 1.9 Billion GlaxoSmithKline has agreed to buy Sierra Oncology and its lead drug assets, momelotinib, for anemia caused by the blood malignancy myelofibrosis. GSK is paying USD 55 per share in cash for Sierra, a 39% premium to the company's closing share price yesterday, valui...

Gilead's Kite Receives Expanded Approval for its CAR-T Yescarta's in Follicular Lymphoma  Gilead’s Kite has successfully secured success in launching the first-ever chimeric antigen receptor (CAR) T-cell therapy in the Follicular Lymphoma Market. The US FDA approved the Yescarta for adults with relapsed or ...

Gilead and Vir Biotechnology Establish Clinical Collaboration  Gilead Sciences, Inc. and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to assess novel therapeutic combination strategies to develop a functional remedy for chronic hepatitis B virus (HBV). T...

Hepatitis is an infection that causes inflammation of the liver. The condition can be self-limiting or can progress to fibrosis (scarring), cirrhosis, or liver cancer. Hepatitis viruses are the most common cause of hepatitis; however, other infections such as toxic substances (e.g., alcohol, certain drugs) and auto...

Albireo Pharma Hopeful to Commercialize its PFIC Treatment by the End of the Year Albireo Pharma, spun out of AstraZeneca, has long been working on developing potential and efficient treatment drugs for the patients suffering from progressive familial intrahepatic cholestasis (PFIC), a rare disorder that leads t...

FDA rejects BioMarin's gene therapy and Gilead's filgotinib over concerns The FDA refused to approve BioMarin's hemophilia A gene therapy valoctocogene roxaparvovec. The U.S. regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) lett...