Lexington, Mass.-based Agenus withdrew the company’s Biologics License Application (BLA) for the PD-1 inhibitor balstilimab from the U.S. Food and Drug Administration.
Biogen Inc. is pinning hopes on a decision on U.S. government coverage of the company’s Alzheimer’s disease drug during 2022 to help drive up Aduhelm’s usage, after a big miss on third-quarter 2021 sales of the much-awaited treatment.
Merck is recalling some 22,000 vials of 500 mg Cubicin for intravenous injection following a complaint that a piece of glass was found in one of the vials post reconstitution.
Biogen Inc.’s Alzheimer’s drug will be of little help to the company’s third-quarter sales, Wall Street analysts said, as the drugmaker faces an uphill task of convincing hospitals and clinics to use the $56,000-a-year treatment and insurers to reimburse Aduhelm.
Shares in Adamis Pharmaceuticals rose 31 percent on Oct. 18 on news that the U.S. Food and Drug Administration approved the company’s naloxone injection Zimhi for the treatment of opioid overdose. This was Adamis’ third attempt to have the drug approved, following two CRLs.
Michigan-based Esperion on Oct. 18 announced a plan to reduce the company’s overall workforce by 40 percent and significantly decrease operational expenses in fiscal years 2021 and 2022 to optimize long-term growth.
The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Two years after spinning out from Japan’s Takeda, Phathom Pharmaceuticals is primed to take the company’s acid blocker to the U.S. market with another successful trial.
Oyster Point Pharma Inc.’s treatment for dry eye disease became the first U.S. approved nasal spray for the chronic condition on Oct. 18, sending the drug developer’s shares higher.
AstraZeneca announced positive high-level data from the HIMALAYA Phase III trial of a single, high priming dose of tremelimumab plus Imfinzi (durvalumab) in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, who had not had previous systemic therapy and were not eligible for localized treatment.