The CDC’s Advisory Committee on Immunization Practices again took up the matter of risk vs. benefit with the COVID-19 vaccine made by Johnson & Johnson, and proved significantly less skeptical at its second meeting. The FDA and CDC swiftly determined that the recommended pause should be lifted and use of the vaccine should resume.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Cloud Dx, Dhl Holdings, Emed, Illumina, Inter Medico, Jolly Good, Kartos Therapeutics, McKesson, Premier, Quidel, Sight Diagnostics, Spacelabs Healthcare, Teijin Pharma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, ADC, Biogen, BMS, Calliditas, Eisai, Gilead, Glaxosmithkline, Hua, Leo, Medicago, Merck, Protara, Roche, Shanghai Henlius, Shorla.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Courage, E-therapeutics, Ethypharm, Galapagos, Inovio, Life.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Arena, Avillion, Boehringer Ingelheim, Brickell, Bristol Myers Squibb, Eli Lilly, EMD Serona, Incyte, Janssen, Nicox, Novartis, Novavax, UCB, Verona.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Better Therapeutics, Diacarta, Elixir Medical, Solace Therapeutics.
HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.
The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biostable Science & Engineering, Cerus Endovascular, Empowered Diagnostics, Enzo Biochem, Johnson & Johnson Vision, Medtronic.
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