The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Merck KGaA has named Chris Round as President of EMD Serono, the North American healthcare business of Merck KGaA. The company also announced recruitment is ongoing for the Head of China & International of its healthcare business.
Mr....
The US Food and Drug Administration (FDA) has updated its question-and-answer guidance regarding facility inspections during the COVID-19 pandemic to clarify regulatory actions to take place when onsite inspections are not feasible.
The revisions...
Bristol-Myers Squibb (BMS) and Agenus, a Lexington, Massachusetts-based clinical-stage immuno-oncology company, have entered into a $1.56-billion agreement for Agenus’ bispecific antibody program.
Under the agreement, BMS will be granted a global...
The latest on COVID-19 vaccines/drugs and manufacturing from Lilly, Moderna, Roche, AstraZeneca, GSK, CureVac, Novavax, Inovio, and 3M.
Manufacturing and supply of COVID-19 vaccines and drugs
Lilly Enters Mfg Pacts with Cipla, Sun Pharma, Lupin...
The European Commission (EC) has signed a new contract with Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, to secure 1.8 billion doses of the companies’ COVID-19 vaccine. Separately, BioNTech has announced plans to establish a...
The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Pfizer’s and BioNTech’s COVID-19 vaccine to include individuals 12 to 15 years of age. The companies also have initiated a biologics license...
The US Food and Drug Administration (FDA) has issued a final guidance on pharmaceutical product lifecycle management in line with a recent guideline from the International Conference on Harmonization of Technical Requirements for Pharmaceuticals...
Eli Lilly and Company and MiNA Therapeutics, a London-based company developing RNA activation therapeutics, have entered into global research collaboration for small activating RNA (saRNA) therapeutics in a $1.25-billion deal ($25 million upfront...
The European Medicines Agency (EMA) is implementing additional temporary measures to further streamline activities in the European medicines regulatory network to enable experts to deal with an increasing volume of COVID-19-related assessment...
The European Commission (EC) has proposed a strategy to support the development and availability of COVID-19 vaccines and treatments in the European Union (EU), which includes funding for research and manufacturing.
The EU Vaccines Strategy covers...
Biogen and Capsigen, a Vancouver, Washington-based gene-therapy company, have entered into a strategic research collaboration to develop gene therapies for central nervous system (CNS) and neuromuscular disorders, in a deal worth up to $1.3 billion...
Roivant Sciences, a New York-based bio/pharmaceutical and healthcare technology company, and Montes Archimedes Acquisition Corp. (MAAC), a special purpose acquisition company (SPAC) sponsored by Patient Square Capital, have formed a merger...
The Biden Administration has issued support for a proposal to temporarily waive intellectual property (IP) rights for COVID-19 vaccines as a means to increase vaccine access in developing countries, a position supported by the World Health...
A roundup of news from Canada (AbCellera), Germany (Merck KGaA and MoonLake Immunotherapeutics), and the US (Pfizer, Sanofi, and Acella Pharmaceuticals).
Canada
AbCellera Breaks Ground on New Global HQ AbCellera, a Vancouver, British Columbia,...
Teva Pharmaceutical Industries, Eli Lilly and Company, and Viatris, the new company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, have outlined environmental, social, and...
