The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The US Food and Drug Administration (FDA) has issued guidance, Control of Nitrosamine Impurities in Human Drugs, for immediate implementation. The guidance recommends steps, including a comprehensive risk-assessment strategy and other actions...
The latest on manufacturing and potential treatments for COVID-19 with news from Moderna, Sanofi, GSK, Abbott, Roche, Gilead, Novartis, Daiichi Sankyo, and others.
Moderna in Talks to Supply Japan with 40 M Doses of COVID-19 VaccineModerna, a...
The government of Canada has reached agreements with Johnson & Johnson’s Janssen and Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, to supply their respective vaccines against SARS-CoV-2, the virus that causes...
Novartis has set a target to achieve full carbon neutrality across its supply chain by 2030, in addition to its already stated target for carbon neutrality in its own operations by 2025. This new target replaces a previous target aiming for a 50%...
Nestlé Health Science (NHSc) has agreed to acquire Aimmune Therapeutics, a company developing and commercializing treatments for food allergies, for approximately $2.1 billion. The move provides Nestlé with the remaining shares of Aimmune not...
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, reports that it will add more than 400 new jobs at its Industrial Operations and Product Supply (IOPS) campus in Limerick, Ireland, to bring the total headcount at...
The UK’s Medicines and Healthcare products Regulatory Agency reports that it plans to resume on-site UK risk-based GxP inspections in September (September 2020) and scale up to a full program in October (October 2020).
The agency had suspended its...
The latest on manufacturing and potential treatments and testing for COVID-19 with news from Moderna, Pfizer, Novavax, AstraZeneca, Gilead Sciences, Qiagen, and others.
Moderna Concludes Talks for EU Supply Pact for COVID-19 VaccineModerna, a...
A roundup of news from the US (AbbVie, Colorcon Ventures, BioMarin Pharmaceutical, and Bayshore Pharmaceuticals).
AbbVie, Harvard Form $30-M Research Pact for Emergent Viral DiseasesAbbVie and Harvard University have entered into a $30-million...
Blackstone, a private investment firm, has agreed to acquire Takeda Consumer Healthcare Company (TCHC), a subsidiary of Takeda and a provider of over-the-counter (OTC) medicines in Japan, for a total value of JPY 242.0 billion ($2.3 billion).
The...
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing a messenger ribonucleic acid (mRNA) therapeutics, and the European Commission (EC) have concluded exploratory talks outlining an advanced purchase agreement to...
Bristol Myers Squibb (BMS) has agreed to acquire Forbius, a Montréal-based clinical-stage biopharmaceutical company developing biotherapeutics for treating cancer and fibrotic diseases. Financial terms were not disclosed.
Forbius has developed a...
The latest on manufacturing and potential treatments for COVID-19 with news from J&J, Novavax, Roche, Regeneron, BI, Dr. Reddy’s, CSL, and others.
J&J in Supply Pact with UK Gov’t for its COVID Vaccine Candidate Janssen Pharmaceutica NV,...
A roundup of news from Denmark (Novo Nordisk), Germany (Evotec, Novo Nordisk), Japan (Takeda), and the US (Lupin, Sun Pharma, Alnylam, Teva, and others).
Denmark
Novo Nordisk To Invest $135 M in Danish Production FacilitiesNovo Nordisk plans to...
Gilead Sciences has been issued a Complete Response Letter (CRL) by the US Food and Drug Administration (FDA) for its new drug application (NDA) for filgotinib, an investigational drug for treating moderately to severely active rheumatoid...
