The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, and Takeda plan to recall three lots of Moderna’s COVID-19 vaccine in Japan due to the presence of foreign particulates observed in unused vials of one...
Roche and Shape Therapeutics, a Seattle, Washington-based company developing RNA technologies for gene therapies, have entered into a multi-target collaboration and license agreement, worth up to $3 billion, to advance adeno-associated virus...
The US Food and Drug Administration (FDA) has approved the biologics license application (BLA) for Comirnaty, Pfizer’s and BioNTech’s COVID-19 vaccine, in individuals 16 years of age and older, making it the first COVID-19 vaccine to be granted...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, Moderna, J&J, Roche, AstraZeneca, Sanofi, GSK, Regeneron, Emergent BioSolutions, and others.
Manufacturing and supply of COVID-19 vaccines and...
Eli Lilly and Company and Lycia Therapeutics, a South San Francisco, California-based bio/pharmaceutical company, have entered into a multi-year research collaboration and licensing agreement for the discovery, development, and commercialization of...
A roundup of news from Africa (Cipla), South Korea (ExoCoBio), the UK (Center for Process Innovation), and the US (Vertex).
Africa
Cipla Reopens Mfg Facility in South Africa Cipla, a Mumbai, India-based bio/pharmaceutical company, has reopened...
Pfizer has agreed to acquire Trillium Therapeutics, a Mississauga, Ontario, Canada-based clinical-stage immuno-oncology company, for $2.26 billion.
Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47...
Johnson & Johnson (J&J) has announced that Alex Gorsky, currently Chairman and Chief Executive Officer (CEO), will step down as CEO to serve as Executive Chairman of J&J and transition the role of CEO to Joaquin Duato, currently Vice...
The European Medicines Agency (EMA) has endorsed the recommendations of the International Coalition of Medicines Regulatory Authorities (ICMRA) that address the regulatory oversight of artificial intelligence (AI) in medicines development. ICMRA is...
The US Food and Drug Administration (FDA) will begin a review of a third dose in all adults of the Pfizer/BioNTech and Moderna COVID-19 vaccines to be given eight months after their second dose. Pending review and approval by the FDA and dosing...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Roche, Moderna, Merck & Co., GSK, CureVac, Gristone, CEPI, and Thermo Fisher Scientific.
Manufacturing and supply of COVID-19 vaccines and drugs
Roche Reports Shortages...
A roundup of news from Germany (Boehringer Ingelheim and CureVac) and the US (Artiva Biotherapeutics and Alladapt Immunotherapeutics).
Germany
BI, CureVac To End mRNA Cancer Vaccine PactCureVac, a Tubingen, Germany-based clinical-stage...
The US Food and Drug Administration (FDA) is informing patients, healthcare providers, and manufacturers about cybersecurity vulnerabilities with a real-time operating system (RTOS) designed by QNX and owned by BlackBerry that may introduce risks...
Pfizer is voluntarily recalling an additional four lots of its smoking-cessation product, Chantix (varenicline) (0.5 mg/1 mg tablets) to the patient (consumer/user) due to the presence of a nitrosamine impurity, N-nitroso-varenicline, potential...
Eli Lilly and Company has announced that Lilly Bio-Medicines will split into two business units: Lilly Neuroscience and Lilly Immunology, effective September 5, 2021. Lilly also announced executive leadership changes.
Anne White, currently Senior...
