A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bio Products, Daiichi, Incyte, Jiangsu Recbio, Kempharm, Moleculin, Newsoara, Palisade, Vistagen, Xortx.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cannvalate, Clover, Editas Medicine, Iqvia, Lanova, Lumos, Microba, Olix, Oxurion, Phathom, Phosplatin, South, Tetra, Tikomed, Turning.
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
For the first time since the early weeks of the COVID-19 pandemic in 2020, global deaths caused by the disease have fallen to their lowest point, as immunity against the SARS-CoV-2 virus and its variants continues to build. Infections and deaths appear to be decelerating, an optimistic sign that the pandemic may be nearing an end.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abeona, Adial, Asceneuron, Aura, Betta, Botanix, Brickell, Cero, Cognition, Eyepoint, Helsinn, Juniper, Nordic Nanovector, Spero.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Axsome, Biogen, Coherus, Horizon, Hutchmed, Ideaya, Junshi, Moderna, Myovant, Novavax, Regeneron, Sage, Supernus, Vaxxinity, Vertex, Vitti.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Aptorum, Kala, Milestone, Sorrento, Tarsus, Vertex, Zynerba.
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