Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Biogen, BMS, Gilead, Gracell, Moderna, Pfizer, Roche.
LONDON – Medical research charities that form an integral part of the U.K. health research system are still reeling from the impact of COVID-19 and now expect it will be three years before funding returns to pre-pandemic levels.
The FDA amended emergency use authorizations (EUAs) for the Moderna Inc. COVID-19 vaccine as well as the shot from Pfizer Inc. and Biontech SE. A single booster dose was green-lighted for people 18 years and older at least six months after finishing the primary regimen with either of the vaccines, or at least two months after getting the Johnson & Johnson shot.
Assure Tech (Hangzhou) Co. Ltd. made its debut on the Shanghai Stock Exchange Star Market and raised ¥1.2 billion (US$188 million) in the IPO. Its shares increased 19.28% in the middle of the first trading day but closed 6.73% lower the second day.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Armata, Bridgebio, Cellectis, Curevac, Cytodyn, Cytovia, Enterin, Glaxosmithkline, Helsinn, Innovation, Locanabio, Pfizer, Schrödinger, Second Genome, Shenzhen Kangtai Biological Products, Voyager.
Sense Biodetection Ltd. closed a $65 million series B investment round on a high note with an additional $15 million pouring in from previous investors. The Abingdon, England-based company raised $50 million in a first tranche of the round in April. Koch Disruptive Technologies LLC, a subsidiary of Koch Industries Inc., led both parts of the round.
Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Biogen, Biohaven, Cytodyn, Eisai, Mirati, Moderna, Novavax, Owp, Pfizer, Prilenia, Santhera, Serum Institute, Zentalis.
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