Shares of ImmunoGen climbed on Feb. 15 after the company announced an antibody-drug conjugate (ADCs) collaboration with Eli Lilly valued at up to $1.7 billion.
Roivant Sciences launched the new subsidiary Hemavant, which hit the ground running with a licensing agreement from Eisai for RVT-2001, a potential first-in-class small molecule SF3B1 modulator.
The U.S. Food and Drug Administration sent Denali Therapeutics a formal clinical hold letter regarding the investigational new drug (IND) application for the company’s Alzheimer’s drug candidate DNL919.
Lilly and Roche expressed their criticism of the draft guidance from the U.S. Centers for Medicare & Medicaid Services (CMS) for Biogen’s Alzheimer’s drug Aduhelm (aducanumab).
Pardes Biosciences Inc. said on February 14 the company expects to start a mid-to-late-stage trial of its experimental COVID-19 antiviral pill by mid-2022, following promising data from early human testing.
Shares of Cassava Sciences were up more than 5% in premarket trading on February 11 after the U.S. Food and Drug Administration denied a Citizen Petition filed during 2021 on behalf of short-selling clients who sought to suspend the company’s Alzheimer’s clinical trials.
ReutersGilead Sciences Inc.’s antiviral drug remdesivir showed antiviral activity against Omicron, Delta and other variants of the coronavirus in laboratory studies, the company said on February 11.
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
Novavax Inc. said on February 10 the company’s two-dose vaccine was 80% effective against COVID-19 in a late-stage trial testing the shot in teens aged 12 to 17 years.
An antibody-based COVID-19 therapy developed by GSK and Vir Biotechnology retains neutralizing activity against the emerging BA.2 form of the Omicron coronavirus variant, according to data from a laboratory study cited by Vir on February 10.
