The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
A roundup of news from Canada (AbCellera, Moderna), Germany (BI, Twist Bioscience), Switzerland (Sandoz, Bio-Thera), and the US (Citius Pharma, Dr. Reddy’s, Novo Nordisk).
Canada
AbCellera, Moderna in Antibody Pact AbCellera, a Vancouver-based...
The US Food and Drug Administration (FDA) has established a new Office of Digital Transformation to reorganize the agency’s information technology (IT), data management, and cybersecurity functions.
The Office will report directly to the FDA...
The latest on COVID-19 vaccines/drugs and manufacturing from J&J, Lilly, Regeneron, Moderna, Pfizer/BioNTech, CureVac, Valneva, Sinovac, and the FDA.
Manufacturing and supply of COVID-19 vaccines and drugs
FDA OKs Additional Batch of...
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has launched a voluntary novel excipient review pilot program, which is intended to allow excipient manufacturers to obtain FDA review of certain novel...
AbbVie and Regenxbio, a Rockville, Maryland-based bio/pharmaceutical company, have entered into a partnership to develop and commercialize Regenxbio’s RGX-314, a gene therapy for chronic retinal diseases, in a deal worth up to $1.75 billion ($370...
Sanofi has completed its $3.2-billion acquisition of Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics and vaccines company.
Translate Bio has an early-stage pipeline in cystic fibrosis and other rare pulmonary diseases. Its lead...
The Biden Administration has laid out a $65.3-billion, multi-year post-pandemic plan for US preparedness against future pandemics and biological threats, which includes $36 billion for vaccine and therapeutic development and manufacturing and $2.1...
Swedish Orphan Biovitrum (Sobi), a Stockholm, Sweden-based bio/pharmaceutical company specializing in rare diseases, has received an offer from private equity firms, Advent International and Aurora Investment, an affiliate of GIC, through Agnafit...
Sanofi has agreed to acquire Kadmon Holdings, a bio/pharmaceutical company, for $1.9 billion to advance its transplant business. Kadmon’s pipeline includes drug candidates for immune and fibrotic diseases as well as immuno-oncology...
Adaptimmune Therapeutics, an Oxfordshire, UK-based T-cell therapy company, has entered into a strategic collaboration and license agreement with Roche’s Genentech to develop and commercialize allogeneic cell therapies to treat multiple oncology...
The latest on COVID-19 vaccines/drugs and manufacturing from AstraZeneca, Pfizer, Moderna, Takeda, Amgen, Novavax, Gates Foundation, the WHO, and Sinovac.
Manufacturing and supply of COVID-19 vaccines and drugs
AstraZeneca, EU Reach Settlement...
Perrigo has agreed to acquire Héra SAS (HRA Pharma), a Paris-based over-the-counter (OTC) consumer self-care company, for EUR 1.8 billion ($2.1 billion) from funds affiliated with the private equity firm, Astorg, and Goldman Sachs Asset...
A federal bankruptcy court has approved a reorganization plan by Purdue Pharma, manufacturer of the opioid, Oxycontin (oxycodone), under which the company will be dissolved to form a new company focused on opioid abatement and the company’s owners,...
A roundup of news from Africa (BioNTech), Canada (Genevant, Takeda), Germany (BMS, Evotec) India (Cipla, Kemwell) and the US (Pfizer, AstraZeneca, Thermo Fisher and others).
Africa
BioNTech To Establish mRNA Vaccine Mfg in Africa BioNTech, a...
The latest on COVID-19 vaccines/drugs from Pfizer, Moderna, Merck & Co., Lilly, GlaxoSmithKline, SK bioscience, CureVac, and Novavax.
Updates on COVID-19 treatments and vaccines
FDA To Hold Meeting on Pfizer’s/BioNTech’s COVID-19...
