The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Bayer, through its subsidiary, Monsanto, has filed a petition for a writ of certiorari with the US Supreme Court requesting that the Court review a federal appeals court decision in a product-liability case over Roundup, its glyphosate-based...
The UK Medicines and Healthcare products Agency (MHRA) is recalling 25 batches of irbesartan-containing products as a precautionary measure due to contamination with an azido impurity, which the agency says has mutagenic potential. The batches are...
The European Medicines Agency (EMA) has endorsed the International Coalition of Medicines Regulatory Authorities' (ICMRA) recommendations to facilitate the use of track-and-trace systems at the global level. The ICMRA, a voluntary, executive-level...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from AstraZeneca, Moderna, Sk Bioscience, Inovio, Sinovac, the FDA, the World Health Organization, and Thermo Fisher Scientific.
Manufacturing and supply of COVID-19 vaccines and...
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, expect annual manufacturing capacity for BNT162b2, their COVID-19 vaccine, to reach three billion doses by the end of 2021 and up to four billion doses in 2022. BioNTech provided...
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced a memorandum of understanding with the Canadian government to build a mRNA vaccine-manufacturing facility in Canada.
The facility would...
A roundup of news from Japan (Astellas, Minovia) and the US (Gilead Sciences, Alnylam, Lumen Bioscience, and Spectrum Pharmaceuticals).
Japan
Astellas, Minovia Therapeutics in Cell-Therapy PactAstellas and Minovia Therapeutics, a Haifa,...
Kite, part of Gilead Sciences, and Appia Bio, a Los Angeles, California-based bio/pharmaceutical company developing engineered allogeneic cell therapies from hematopoietic stem cells (HSCs), have entered into a collaboration and license agreement...
Takeda is investing $126 million at its site in Thousand Oaks, California for a new 15,000-square-foot manufacturing facility and a renovation of 14,000-square feet of manufacturing space at its existing facility. The investment increases the...
Bayer has agreed to acquire Vividion Therapeutics, a San Diego, California-based bio/pharmaceutical company focused on cancers and immune disorders, in a deal worth up to $2 billion ($1.5 billion upfront and up to $500 million in milestone...
A roundup of news from Canada (Bausch Health Companies), Germany (CureVac, Janssen, BioMed X) and the US (Viatris, Biocon).
Canada
Bausch Health Completes $740-M Sale of Amoun Pharmaceuticals Bausch Health Companies, formerly Valeant...
The latest on COVID-19 vaccines/drugs and manufacturing from Novavax, Moderna, Lilly, Regeneron, CureVac, Glenmark, and the World Health Organization.
Manufacturing and supply of COVID-19 vaccines and drugs
EU To Purchase Up To 200 M Doses of...
Sanofi has agreed to acquire Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, for a total equity value of approximately $3.2 billion.
Translate Bio has an early-stage pipeline in cystic fibrosis and other rare pulmonary...
Eli Lilly and Company, through Loxo Oncology, a Lilly R&D group, and Kumquat Biosciences, a drug-discovery and development company, have entered into an exclusive collaboration to discover, develop, and commercialize small-molecule drugs for...
BioNTech, a Mainz, Germany-based immunotherapy company, has completed its acquisition of a solid-tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, Maryland from Kite, part of Gilead...
