Johnson & Johnson said on March 31 the company had found a problem with a batch of the drug substance for its Covid-19 vaccine being produced by Emergent BioSolutions, and said the batch did not advance to the final fill-and-finish stage.
A large plant being used to manufacture Johnson & Johnson’s Covid-19 vaccine was cleared by U.S. regulators on March 23, setting the stage for the weekly U.S. supply to surge more than 20 percent.
Merck & Co. will help make rival Johnson & Johnson’s Covid-19 vaccine in order to boost the slower-than-promised production of the one-dose shot, U.S. President Joe Biden said on March 2.
Bristol Myers Squibb announced plans for a new manufacturing plant in Devens, Mass., adding to the company’s cell therapy network.
French healthcare company Sanofi will provide Covid-19 vaccine manufacturing support to U.S. peer Johnson & Johnson.
The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court.
Spectrum Pharmaceuticals announced that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration can approve the company’s Biologics License Application for Rolontis (eflapegrastim).
Eli Lilly hired an independent consultant to review a plant producing the company’s Covid-19 antibody drug after receiving a notice from the U.S. health regulator.
Novavax Inc. expects filing for approval of the company’s Covid-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny.
China’s SinoVac is starting Phase III trials of a potential coronavirus vaccine, becoming one of three companies to move into the late stages in the race to develop an inoculation against the disease.