The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, J&J, Regeneron, AstraZeneca, Biogen, CureVac, Inovio, and Novavax.
Manufacturing and supply of COVID-19 vaccines and drugs
COVAX To Buy 176.5-M Additional Doses of...
Pfizer and Voyager Therapeutics, a Cambridge, Massachusetts company developing gene therapies, have entered into a licensing agreement under which Pfizer may exercise options to license capsids generated from Voyager’s screening technology to...
Sandoz, the generics and biosimilars arm of Novartis, has completed the acquisition of GlaxoSmithKline’s (GSK) cephalosporin antibiotics business, in a deal worth up to $500 million.
The companies had first announced the deal in February (February...
GlaxoSmithKline (GSK) has announced initial plans for a new UK-based headquarters site for its new Consumer Healthcare company as well as longer-term plans for a new headquarters site for all of GSK, which includes its pharma and vaccines...
Merck & Co. has submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral agent for treating mild-to-moderate COVID-19 in adults who are at risk...
A roundup of news from the US (Bayer, AstraZeneca, Takeda, Caelum Biosciences, Selecta Biosciences, and MannKind Corporation).
US
Bayer Recalls Select Lots of OTC Antifungal Aerosol Products Bayer is voluntarily recalling all unexpired Lotrimin...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, Takeda, Merck & Co., J&J, AstraZeneca, Sanofi, Celltrion, and Thermo Fisher Scientific.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna,...
Moderna has announced plans to build a new $500-million mRNA vaccine production facility in Africa for its COVID-19 vaccine and its other vaccine candidates with the goal of producing up to 500 million doses of vaccines each year at a 50-µg dose...
The European Medicines Agency (EMA) has authorized booster doses of Pfizer’s/BioNTech’s and Moderna’s COVID-19 vaccines, Comirnaty and Spikevax, respectively.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive...
Boehringer Ingelheim (BI) has inaugurated a new EUR 700-million ($809-million) large-scale, cell-culture biomanufacturing facility in Vienna, Austria.
With an investment of more than EUR 700-million ($809 million), it is the single largest...
Bayer has announced plans to invest over EUR 400 million ($462 million) to increase production capacity for its contraceptives with the addition of two new facilities, respectively in Turku, Finland, and the Alajuela, Costa Rica.
The investment...
The US Food and Drug Administration (FDA) has issued a draft guidance to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs).
The draft guidance, Microbiological Quality Considerations in...
Hikma Pharmaceuticals, a pharmaceutical company and supplier of generic injectable medicines, has agreed to acquire Custopharm, a Carlsbad, California-based a generic injectable drug company, from Water Street Healthcare Partners, an investment...
Merck & Co. has agreed to acquire Acceleron Pharma, a Cambridge, Massachusetts-based bio/pharmaceutical company, for an approximate total equity value of $11.5 billion.
Acceleron focuses on using the transforming growth factor (TGF)-beta...
A roundup of news from China (Neurophth Biotechnology), India (Biocon), and the US (Lilly, AstraZeneca, Teva Pharmaceuticals, and Moderna).
China
Neurophth Opens Gene-Therapy Mfg Facility Neurophth Biotechnology, a Wuhan, China-based genomic...
