AstraZeneca and Amgen’s experimental drug tezepelumab reduced asthma attacks in patients with severe and uncontrolled forms of the respiratory condition in a large study, showing promise for wider use against different triggers.
Bristol Myers Squibb announced plans for a new manufacturing plant in Devens, Mass., adding to the company’s cell therapy network.
The U.S. Food and Drug Administration accepted for Priority Review Pfizer Inc.’s Biologics License Application for TicoVac, the company’s tick-borne encephalitis vaccine for active immunization to prevent TBE in individuals 1 year of age and older.
Bristol Myers Squibb reported that the company was abandoning the BCMA CAR-T therapy orva-cel and taking a $470 million write-off.
The lack of face-to-face meetings during the Covid-19 pandemic caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals, and a news feature published in Nature Biotechnology suggests these workarounds are here to stay.
The U.S. Food and Drug Administration extended the review period for Biogen and Eisai’s Biologic License Application (BLA) for aducanumab for Alzheimer’s disease.
As the 2021 virtual J.P. Morgan Healthcare Conference wrapped up, BioSpace reviewed news from companies regarding their deals, pipeline and regulatory updates.
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.
Humanigen Inc. and EVERSANA announced that they are partnering to make lenzilumab available to hospitalized and hypoxic Covid-19 patients in the event that an Emergency Use Authorization is issued from the U.S. Food and Drug Administration and subsequent BLA.
DBV Technologies unveiled a global restructuring plan that will result in a reduction of more than 200 jobs.