With the June 9 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee party-line vote of 12-11, Susan Monarez’s nomination is headed to the Senate floor where she could become the first CDC director to go through the confirmation process. That’s thanks to a provision in the bipartisan PREVENT Pandemics Act that was signed into law in 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allurion, Astrazeneca, Denali, Kalvista, Lexeo, Mustang, Nurix.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alembic, Biotx.ai, Brii, Chugai, Gero, Heartbeat, Joincare, Laboratoires Théa, Lenz, Utility.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Apogee, Beyondspring, Blue Lake, Cogent, Cyanvac, Immix, Jasper, Yiviva.
New hires and promotions in the biopharma industry, including: Allarity, Baxter, Biocryst, Genelux, Immunoprecise Antibodies, Immuthera, Nervgen, Nuevocor, Sellas.
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.
Veritas In Silico Inc. (VIS) entered a joint research agreement with Mitsubishi Gas Chemical Co. Inc. to use VIS’s mRNA structural motif analyzing platform technology, called Ibvis, to develop antisense oligonucleotide drug candidates.
In yet another fail for the Duchenne muscular dystrophy (DMD) field, Taiho Pharmaceutical Co. Ltd.’s pizuglanstat (TAS-205) did not meet the primary endpoint in a phase III trial. The phase III Reach-DMD trial, a randomized, placebo-controlled, double-blind and open-label, extension study of pizuglanstat in patients with DMD showed no significant difference in the mean change from baseline to 52 weeks in the primary endpoint of time to rise from the floor in the ambulatory cohort of the study.
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