GSK Bio

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FDA
ImmunoGen’s Elahere was approved Monday under the FDA’s accelerated pathway for patients who have received one to three previous lines of systemic therapy.
At the FDA’s request, GSK has restricted the use of Zejula, a PARP inhibitor, to a specific population as a second-line maintenance treatment for ovarian cancer following updated data.
GSK and Sanofi veteran Christopher A. Viehbacher will take over as chief executive officer for Biogen. He replaces Michel Vounatsos, whose departure was announced in May.
With a fresh $18 million in the bank, NRG Therapeutics is ready to put its novel mitochondrial approach to the test for devastating neurodegenerative disorders—Parkinson’s and ALS.
Bankruptcy might be looming for embattled Clovis Oncology, the company warned Wednesday in a 10-Q filing. Clovis also revealed it has taken action to reduce its workforce by 115 employees.
Adaptimmune has had a manic Tuesday, touting improved efficacy numbers for its T-cell candidate while also dealing with economic repercussions of its terminated partnership with GSK.
GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses.
GSKs Blenrep misses the mark in the Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), possibly putting the drug’s continued approval at risk.
Sanofi and AstraZeneca won European approval for the first preventative RSV treatment for a broad population of newborns and infants.
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