The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have reported positive interim efficacy data of their COVID-19 vaccine candidate, BNT162b2, from a Phase III study, which found the vaccine to be more than 90% effective in...
Novo Nordisk has agreed to acquire Emisphere Technologies, a Roseland, New Jersey-based drug-delivery company, for $1.8 billion.
Novo Nordisk and Emisphere have collaborated since 2007. Emisphere’s drug-delivery technology, Eligen SNAC, is used by...
Merck KGaA has taken a 10% equity stake and formed an out-licensing agreement with Vera Therapeutics, a San Francisco, California-based biopharmaceutical company, for the further development of Vera’s investigational therapy, atacicept, an...
Endo International, a generics and specialty branded pharmaceuticals company, has announced it is reducing staff by 560 and exiting some manufacturing sites.
To improve its cost structure in its generics business, Endo is exiting manufacturing...
Mylan and Pfizer have received final approval from the US Federal Trade Commission for their proposed combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business. The companies had announced the planned...
The European Medicines Agency (EMA) has issued a detailed plan to implement recommendations for reducing the risk of medicines that contain nitrosamine impurities.
Certain nitrosamines are classified as probable human carcinogens, and nitrosamine...
Pfizer has announced it will make a EUR 300-million ($351-million) capital investment in its Irish operations to support the further development of its existing manufacturing sites in Grange Castle, Newbridge, and Ringaskiddy.
The investment will...
The latest on manufacturing and potential treatments for COVID-19 with news from Johnson & Johnson, Novavax, Regeneron, CureVac, Aspen Pharmacare, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
J&J, Aspen Pharmacare...
Merck & Co. has agreed to acquire VelosBio, a San Diego, California-based clinical-stage company developing cancer therapies, for $2.75 billion.
VelosBio develops cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1...
Sanofi has agreed to acquire Kiadis Pharma, an Amsterdam-based clinical-stage company developing therapeutics based on natural killer (NK) cells, for EUR 308 million ($358 million).
Kiadis’ proprietary platform is based on allogeneic or...
A roundup of news from Japan (Lilly, Daiichi Sankyo, Novartis), the UK (AstraZeneca, GSK), and the US (BMS, Novartis, Vedere Bio, Nostrum Laboratories).
Japan
Novartis Gets OK for CAR-T Cell Therapy Mfg Site in JapanNovartis has received approval...
Johnson & Johnson (J&J) and AstraZeneca have announced plans to resume clinical trials in the US for their respective COVID-19 vaccine candidates after earlier pausing trials due to an unexpected illness of a study participant in their...
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ antiviral drug, Veklury (remdesivir), for treating hospitalized COVID-19 patients, making it the first drug in the US to receive marketing authorization by the FDA to treat...
The latest on manufacturing and potential treatments for COVID-19 with news from Sanofi, GSK, Novartis, Takeda, BI, Moderna, Regeneron, and Novavax.
Manufacturing and supply news for COVID-19 vaccines and drugs
Sanofi, GSK To Supply 200 M Doses...
Eli Lilly and Company has entered into an agreement for $375 million with the US government to supply 300,000 vials of LY-CoV555 (bamlanivimab) (700 mg), the company’s investigational monoclonal antibody for treating COVID-19.
The supply agreement...
