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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anthem, Clinical Enterprise, Diversa, Edwards Lifesciences, Eurofins, Grupo Suprimed, Humacyte, Indica Labs, Inspire MD, Inspire Medical Systems, Mdxhealth, Neovasc, Novacyt, Sanuwave, Viracor.
The EMA issued a positive scientific opinion on Glaxosmithkline plc (GSK) and Vir Biotechnology Inc.’s sotrovimab for early COVID-19 treatment. The Committee for Human Medicinal Products (CHMP)’s opinion concerns the monoclonal antibody’s use for adolescents ages 12 and older weighing at least 40 kg (88 pounds), plus adults. All must risk progressing to severe COVID-19 and not require oxygen supplementation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Alexion, Almirall, Astrazeneca, Athenex, Bayer, Bluebird, BMS, Eli Lilly, Genmab, Glaxosmithkline, Janssen, Larimar, Moderna, Myovant Sciences, Rhythm, Takeda, Vir.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biogen, Bostongene, Ginkgo, Kiromic, Nektar, Promis, Recce, Selexis, Therapeutic Solutions.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acupath Laboratories, Advanced Human Imaging, Carestream Health, Caris Life Sciences, Essenlix, Haliodx, Hewlett Packard Enterprise, Labcorp, Max Pharma, Micron Medical, Recuro Health, Roche, Supdoc, Test Today USA, Xphyto.
As infections and deaths continue to surge in some countries so does the demand for unfettered access to the technologies behind COVID-19 vaccines and other medical products. In seeking that access, several countries are stressing the need to develop their own manufacturing capacity as they look beyond the current pandemic.
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