Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB, Abbvie, Acceleron, Alnylam, Altimmune, Azurrx, Bioxcel, Celon, Celsion, Hanx, Kedrion, Leap, Newron, Onconova, Passage, Pfizer, Relmada, Revance, Springworks, Synaptogenix, Synthetic, Yingli.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief:, Agilent Technologies, Alydia, B. Braun, Delfi Diagnostics, Infraredx, Janssen, Komodo Health, Merck, Natera, Nipro, Organon, Oscar A-Co, Premier, Takeda, Tempus, Tesis Labs.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.

“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Aptorum, Athersys, Biontech, Equillium, Flexion, Istari, Kamada, Nascent, Outlook, Pfizer, Pharnext, Regeneron.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Binx Health, Gold Standard Diagnostics, Nines.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AI/ML Innovations, Aspect Biosystems, Beigene, Biomax Informatics, Djo Global, Genial Light, Ginkgo Bioworks, Guardant Health, Henry Schein, Hisense, IBH, Insight Medical Systems, Lantheus Holdings, JSR, Mapkure, Materials and Machines, Mimedx, Noria Therapeutics, Olive Labs, Orasure Technologies, Origo, Osang Healthcare, Personalis, Premier, Proscia, Recuro Health, Sciex, Seer, Stradis Medical, Strategic Solutions Group, Teladoc, Texcell, Think Research, Todos Medical, Toyoda Gosei, Trinity Biotech, Unilabs, Uprise, Zi Medical.

The latest global regulatory news, changes and updates affecting biopharma, including: MRNA vaccine efficacy holds in real world; TGA addressing drug shortages; STIs on the rise in U.S.; CDER firm on Makena withdrawal.