The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorization for emergency supply for AstraZeneca's and the University of Oxford's COVID-19 vaccine, making the UK the first country to authorize the vaccine. The...
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have been granted conditional marketing authorization (CMA) from the European Commission (EC) for their COVID-19 vaccine, making it the first COVID vaccine to receive a CMA in the...
A federal district court has ruled in favor of Viatris, the new company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, in litigation brought by Sanofi related to Mylan’s...
The US Food and Drug Administration’s (FDA) has authorized the emergency use of Moderna’s vaccine against COVID-19 in individuals 18 years of age or older, making it the second vaccine against COVID-19 authorized for emergency use in the US. On...
An advisory committee of the US Food and Drug Administration (FDA) met on Thursday of this week (December 17, 2020) to discuss the request by Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and...
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from BioNTech, Sanofi, Lilly, Novartis, Roche, Novavax, CureVac, CLS, Inovio, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
BioNTech,...
Eli Lilly and Company has agreed to acquire Prevail Therapeutics, a New York-based company developing gene therapies, in a $1.04-billion deal ($880 million upfront plus one non-tradable contingent value right worth up to $160 million).
The...
The US government reports the shipment of the first 2.9 million doses of Pfizer’s and BioNTech’s, COVID-19 vaccine, BNT162b2, in the US. The companies received emergency use authorization for the vaccine from the US Food and Drug Administration...
Viatris, the new company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, has provided additional details of its multi-year $1-billion global restructuring initiative, which...
AstraZeneca has agreed to acquire Alexion Pharmaceuticals, a Boston-based biopharmaceutical company focused on rare diseases, for $39 billion.
The acquisition would position AstraZeneca in immunology and the development of medicines for...
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have received emergency use authorization from the US Food and Drug Administration (FDA) for their COVID-19 vaccine, BNT162b2, in individuals 16 years of age or older, making it the...
An advisory committee of the US Food and Drug Administration (FDA) met this week (December 10, 2020) to review the request by Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, for emergency use authorization for their COVID-19...
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have filed lawsuits against the US government for its recently issued drug-pricing rule that uses a Most Favored Nation (MFN)...
Novo Nordisk has completed its $1.8-billion acquisition of Emisphere Technologies, a Roseland, New Jersey-based drug-delivery company. As a result of the completion of the merger, Emisphere has become a wholly owned subsidiary of Novo Nordisk.
The...
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Moderna, AstraZeneca, Lilly, Roche, Thermo Fisher, Inovio, Sinovac, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna Expands...
