Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ambiopharm, Axonics Modulation Technologies, CEM, De Novo Software, Dermtech, Ginkgo Bioworks, Insightful Science, Medtronic, Twist Bioscience, Vitalconnect, Waters.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
While privately held Calcimedica Inc. posted positive top-line results from a phase II study of its lead candidate in treating patients with severe COVID-19 pneumonia, Redhill Biopharma Inc. took a tumble as preliminary top-line data from a phase II/III study of opaganib in treating hospitalized COVID-19 patients showed the endpoints failed to achieve statistical significance.
LONDON – The U.K. government has accepted the recommendation of medical experts and will begin the rollout of COVID-19 boosters from next week, using mRNA vaccines only. That follows data from the U.K. Cov-Boost trial, looking at combinations of initial and booster doses. The results showed Pfizer Inc./Biontech SE’s and Moderna Inc.’s products generated the best immune responses, regardless of which vaccine was administered initially.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivamab, Celonic, Celyn, Chemdiv, Compass, Convergent, Cresset, Curevac, Defence, Eleva, Gwynant, IO, Jupiter, Merck, Mihkal, Molsoft, Novartis, Point, Rentschler, Teva, Wacker.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Alnylam, Beigene, Chiesi, Hummingbird, Hutchmed, Instil, Mirum, Monopar, Redhill, Relief, Scynexis, Tonix, Y-Mabs.
The Biden administration may have jumped ahead of the FDA review when it announced last month that it planned to roll out COVID-19 boosters by Sept. 20, but that’s not likely to happen when it comes to the timing of vaccines for young children.