Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Amivas, Amylyx, Beigene, Bluebird, Guerbet, Homology, Ionis, Mallinckrodt, Merck & Co., Novavax, Nrx, Relief, Veralox.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Atyr, AVM, Bavarian, Orion, Sarepta, Sirona, Umoja, Valneva.
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
Sanofi SA and GSK plc were beat to market during the first wave of COVID-19 by vaccines from upstarts such as Biontech SE and Moderna Inc. – but the French and U.K. vaccine specialists are gaining traction in the race to develop booster shots against newer variants.
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.
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