Global regulatory activity in 2021 has risen by 25% over this time last year, but the proportion of the activity associated with COVID-19 has dropped in recent months.
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Ascletis, Asklepios, Idorsia, Janssen, Optimus, Pharmather, Provention, Sandoz, Scholar Rock, TG, Therapeuticsmd, TLC.
PARIS – Biosynex SA signed a binding offer to acquire 100% of the stock in Avalun SAS, a company developing the Labpad in vitro diagnostic device that provides rapid biological test results from small sample volumes. In Europe, Avalun is currently marketing a follow-up test for patients on anticoagulation therapy using antivitamin K agents, and a test for automated antigen detection for COVID-19.
In seeming opposition to U.S. Trade Representative Katherine Tai’s support of a proposed compulsory World Trade Organization intellectual property (IP) waiver on COVID-19-related medical products, U.S. Vice President Kamala Harris signed onto the G20’s May 21 Rome Declaration that commits the member countries to work to defeat the pandemic within the current flexibilities of the TRIPS agreement by promoting voluntary IP licensing agreements, technology and knowledge transfers, and patent pooling on mutually agreed terms.
With the intense focus on developing COVID-19 diagnostics, sequencing tools, vaccines and treatments, the pandemic is having an outsized impact on the global development of drugs and devices to treat other diseases. Recent data show that more than 1,000 clinical trials worldwide remain disrupted by COVID-19, including 60% of the non-COVID-19 trials being conducted in the U.S., as funding and other resources continue to be directed toward ending the pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Biomarin, Boehringer Ingelheim, Bristol Myers Squibb, Cansino, Kancera, Glenmark, J&J, Merck & Co., Regeneron, Scopus, Verastem.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boehringer Ingelheim, Creative Medical Technology, Dicerna, Hepalink, Mindmed, Moderna, Nextage, Novavax, Pulthera, Resverlogix, Samsung, SK Group, Stemedica, Strongbridge, Synairgen, Xeris.
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