The EMA has a list and it’ll be checking it frequently to avoid shortages with the help of COVID-19 marketing authorization holders and EU members states.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4basebio, Anpac Bio-Medical Science, Bavarian Nordic, Chromadex, Critical Path Institute, Cyanvac, Eleusis, Frederick Gardner Cottrell Foundation, Genmab, Gritstone, Halozyme, Janssen, Kinarus, Perfect Holding, Silver Spike.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Alnylam, Aptevo, Brii, Cend, Fusion, Immunome, Lyndra, Olema, Takeda, Tryp, Verona, Zhittya.
Mittelstand Santé, a new Franco-German health-tech alliance, has just published its first compilation of feedback from executives of French and German health care companies relating to the COVID pandemic. The French contingent is developing proposals aimed at strengthening the resilience of European health care manufacturing.
The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing.
More than two years into the COVID-19 pandemic and nearly 18 months since a vaccine was first available for adults, the U.S. is on the cusp of having vaccines available to the youngest Americans.
Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273.