The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Johnson & Johnson (J&J) has provided and update regarding a pause of use of its COVID-19 vaccine.
Earlier this week (as reported on April 15, 2021), the US Food and Drug Administration (FDA) and the US Centers for Disease Control and...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Novartis, Moderna, Pfizer, Lilly, AstraZeneca, Merck & Co., Regeneron, Thermo Fisher, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Novartis in Pact...
Patrizia Cavazzoni, M.D., has been appointed as Director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). She has served as Acting Director for the past year.
She succeeds Janet Woodcock, M.D., now Acting...
Sanofi has completed two acquisitions: Kymab, a Cambridge, UK-based biopharmaceutical company, in a $1.45-billion deal ($1.1 billion upfront and up to $350 million in milestones) and Tidal Therapeutics, a Cambridge, Massachusetts-based company...
Sanofi plans to invest EUR 400 million ($477 million) over five years to create a vaccine-production site in Singapore.
In partnership with the Singapore Economic Development Board, the new site will mainly supply the Asian region and complement...
The European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) report that a possible link between AstraZeneca’s COVID-19 vaccine and a combination of blood clots and low blood platelets is very rare and...
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, has provided updates on the contract manufacturing of two COVID-19 vaccines respectively from Johnson & Johnson (J&J) and...
A roundup of news from Egypt (Bausch Health), Japan (Daiichi Sankyo, Sanofi), UK (AstraZeneca), and the US (Merck & Co., Sandoz, Zydus, Alembic, and Apotex).
Egypt
Bausch Health To Sell Amoun Pharmaceuticals for $740 M Bausch Health Companies...
Merck & Co. has completed its $1.85-billion acquisition of Pandion Therapeutics, a Watertown, Massachusetts-based company developing bispecific antibody therapeutics for autoimmune diseases. It also has separately agreed to acquire Alydia...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, Pfizer, Lilly, Takeda, CSL, Novavax, Sinovac, Emergent BioSolutions, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
FDA Revises Doses Per Vial...
Servier, a Paris-based pharmaceutical company, has acquired the commercial, clinical, and research-stage oncology portfolio of Agios Pharmaceuticals, a Cambridge, Massachusetts-based pharmaceutical company, for up to $2 billion plus royalties....
Amgen has agreed to acquire Rodeo Therapeutics, a Seattle, Washington-based biopharmaceutical developing small-molecule therapies, in a $721-million deal ($55 million upfront and future contingent milestone payments potentially worth up to an...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from J&J, Pfizer, Moderna, AstraZeneca, GSK, Lilly, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
J&J Issues Statement on COVID-19 Vaccine Mfg Issue...
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has entered into separate manufacturing agreements with GlaxoSmithKline (GSK) and Jubilant HollisterStier, a CDMO of sterile manufacturing, for its COVID-19 vaccine candidate,...
The European Medicines Agency has approved facilities and/or facility expansions in the European Union for COVID-19 vaccines from Pfizer/BioNTech, Moderna, and AstraZeneca.
Pfizer/BioNTech
A new facility at BioNTech’s site in Marburg, Germany was...
