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) provided on update this week (March 19, 2020) on two potential treatments against the novel coronavirus (COVID-19), chloroquine, a drug already approved for treating malaria, lupus and rheumatoid arthritis,...
The US Food and Drug Administration (FDA) has issued an updated guidance (March 16, 2020) to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers to achieve more...
Roche reports that it is working with the US Food and Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Roche’s Actemra/RoActemra (tocilizumab), a drug to treat certain forms of arthritis, for...
The European Commission launches an advisory panel on the novel coronavirus (COVID-19), and the European Medicines Agency and the FDA co-chair first global regulatory workshop on COVID-19.
European Commission Launches COVID-19 Advisory Panel; EMA...
The US Food and Drug Administration (FDA) has announced that it has temporarily postponed all domestic routine surveillance facility inspections due to the novel coronavirus (COVID-19) outbreak and has issued guidance for conducting clinical trials...
Pfizer has issued a five-point plan for its collaboration with industry and government on R&D and manufacturing for vaccines and treatments against the novel coronavirus (COVID-19).
“In this troubling time, Pfizer is committed to doing...
Sanofi and Regeneron Pharmaceuticals, Inc., a Tarrytown, New York-based biopharmaceutical company, have started a clinical program evaluating Kevzara (sarilumab), an antiviral compound, in patients hospitalized with severe COVID-19 (the novel...
Novartis has announced funding and research projects relating to the novel coronavirus (COVID-19), including the creation of a $20-million global fund to support communities impacted by the COVID-19 pandemic, and its participation in cross-sector...
Eli Lilly and Company and AbCellera, a Vancouver, British Columbia, Canada-based biopharmaceutical company, have formed an agreement to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the...
Biogen and Vir Biotechnology sign letter of intent for development and clinical manufacturing of mAbs against coronavirus; AbbVie and Gates Foundation advance research.
Biogen, Vir Biotechnology Sign Letter of Intent for Clinical Mfg of mAbs for...
The European Medicines Agency (EMA) has provided an update on the work of European Union (EU) and national authorities to prevent and manage the presence of nitrosamine impurities in EU medicines.
The issue of nitrosamine impurities in certain...
In response to the novel coronavirus (COVID-19), the US government is providing advanced development support for a rapid diagnostic test and support for potential vaccines and treatments.
The US Department of Health and Human Services' (HHS)...
The US Food and Drug Administration (FDA) has announced this week (March 10, 2020) that it will postpone most inspections of foreign facilities, effective immediately, through April 2020 in response to the novel coronavirus (COVID-19) outbreak....
Fujifilm Cellular Dynamics (FCDI), a developer and manufacturer of human-induced pluripotent stem cells (iPSCs), has begun operations of its new cGMP-compliant iPSC production facility in Madison, Wisconsin. FCDI invested JPY 2.5 billion ($21...
Bora Pharmaceuticals, a CDMO of non-sterile oral solid dosage forms, has agreed to acquire a GlaxoSmithKline’s (GSK) manufacturing facility in Mississauga, Ontario, Canada.
The GSK facility produces approximately 50 different products for over 100...
