The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The latest on manufacturing and potential treatments for COVID-19 with news from Bausch Health, Inovio, the FDA, Bharat Biotech, and the Medicines Patent Pool.
Manufacturing and supply of COVID-19 vaccines and drugs
Generics Companies in Pact...
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have achieved the safety data milestone required by the US Food and Drug Administration (FDA) for submission of emergency use authorization (EUA) for their mRNA-based COVID-19...
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has reported positive interim efficacy data of its COVID-19 vaccine candidate, mRNA-1273, from a Phase III study, which found the vaccine...
Johnson & Johnson (J&J) has expanded its partnership with the US government through a joint commitment from both parties to provide an additional $1 billion ($604 million from J&J and $454 million from the US government) to fund ongoing...
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, is finalizing an agreement with the European Commission (EC) to supply its COVID-19 vaccine, CVnCoV, and is...
Bristol-Myers Squibb (BMS) has completed its $13.1-billion acquisition of MyoKardia, a Brisbane, California-based clinical-stage biopharmaceutical company focused on cardiovascular diseases. BMS had announced the acquisition last month (October...
Mylan and Pfizer have completed their previously announced combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, to form a new company, Viatris. The companies had announced the merger in July...
The latest on manufacturing and potential treatments for COVID-19 with news from CSL, Regeneron, Lilly, AstraZeneca, Novartis, GSK, Novavax, CSL, Moderna, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
CSL Begins...
A roundup of news from India (Biocon) and the US (Biogen and bluebird bio).
India
Biocon Biologics OKs $150-M Capital Injection from Goldman SachsThe board of Biocon Biologics, a biosimilars company and a subsidiary of Biocon, a Bangalore,...
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...
