Top baby formula makers Reckitt Benckiser and Nestle ramped up supplies to the United States to resolve a shortage that has emptied shelves and caused panic among parents. Leading U.S. manufacturer Abbott Laboratories on May 16 announced an agreement with the Food and Drug Administration to resume production of baby formula at the company’s Michigan plant, marking a major step towards resolving the nationwide shortage.
Novartis temporarily suspended the production of the company’s Lutathera and Pluvicto cancer therapies at facilities in Italy and New Jersey after potential quality issues were discovered in their manufacturing.
Axsome Therapeutics said on April 25 the company expects the U.S. health regulator to decline approval for the drug developer’s treatment of acute migraine over unresolved issues of its quality control processes, sending shares of Axsome down 20 percent.
Eli Lilly is facing $165 million in charges and development milestones from the U.S. Securities and Exchange Commission (SEC). The charges come from several in-process research and development projects acquired outside of a business combination.
Bayer said the German drugmaker would invest around 2 billion euros ($2.23 billion) at pharmaceutical manufacturing sites over the next three years, mainly to bolster production of biotechnology products as well as cell and gene therapies.
Gilead Sciences is letting go of 114 employees based out of the company’s Morris Plains, New Jersey facility following an underwhelming response to the results reaped so far from the $21 billion acquisition of Immunomedics in 2020, according to BioSpace.
Lilly is investing $700 million to build a state-of-the-art facility in the Boston Seaport, as part of plans to advance the company’s RNA-based research and development activities.
Johnson & Johnson during late 2021 quietly shut down the only plant making usable batches of the company’s COVID-19 vaccine, the New York Times reported, citing people familiar with the decision.
Novavax, after delays, files for U.S. authorization of COVID-19 vaccine
Adults, Business, COVAX Facility, Covid-19 Data, COVID-19 Vaccines, Covid-19 Variants, Delta Variant (B.1.617.2; India), Emergency Use Authorization (EUA), Facilities/Sites/Manufacturing, FDA, Mexico, Novavax, Omicron (B.1.1.529) (South Africa), R&D, Serum Institute of India, United Kingdom, United States, World Health OrganizationNovavax Inc. filed for emergency use authorization of the company’s COVID-19 vaccine for U.S. adults, a long-awaited step following months of struggles with development and manufacturing problems.
As part of a restructuring of the company’s research and development areas, Tokyo-based Daiichi Sankyo announced the closing of the Plexxikon R&D subsidiary in South San Francisco.