Medical device supply chain considerations became especially salient during the COVID-19 pandemic, but the U.S. FDA is interested in ensuring that supply chains do not hamper patient access going forward. However, Clayton Hall of the Medical Device Manufacturers Association (MDMA) said on a recent FDA webinar that device makers are sometimes at the mercy of their suppliers.
Afrigen Biologics (Pty) Ltd. is teaming up with two Belgian firms to co-develop and produce an mRNA-based COVID-19 vaccine intended for distribution throughout Africa. It’s an open question whether the vaccine will actually contribute to the present pandemic response, given the timelines involved in both validating the production facility that will produce the end product and in running the necessary trials in order to gain approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Acepodia, BMS, Eli Lilly, Hepion, Moderna.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABVC, Affinivax, Amniotics, Anixa, Ashvattha, Emercell, Kinarus, Onward.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AOP, Edgewise, Engrail, Kinarus, Pharmaessentia, Ultimovacs, Xbiotech.
Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biontech, Cytokinetics, Excellthera, Kazia, LG Chem, Moderna, Mydecine, Novartis, Obseva, Pfizer, Rhythm, Sierra, Theramex.
Just days after U.S. FDA advisors unanimously backed use of both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines in children 6 months and older, the FDA has expanded emergency use authorizations for the products. Availability could follow as soon as June 21, after a meeting of the CDC’s ongoing Advisory Committee on Immunization Practices, wraps up June 18.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aquestive, Bavarian, Checkpoint, Cytokinetics, Galecto, Moleculin, Plus, Roche, Sirnaomics, Vicore.
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
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