The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
Once high-flying Bluebird Bio Inc. has found a way out of its financial squeeze, as funds managed by global investment firms Carlyle and SK Capital Partners LP, along with a team of biotech executives, will be taking over the company.
As the flurry of executive orders continues to flow from the White House, leaving in its wake chaos and confusion across the overall health care sector, Tim Opler, managing director of the global health care group at investment firm Stifel, is taking the long view and urging the biopharma sector to continue focusing on innovation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Arctic Vision, Biorestorative, Clearside, CSL, Genmab, Irlab, Polaritybio, Signet, Sobi.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptose, Assembly, Medivir, Novadip, Sellas, Thetis.
Gene therapy specialist Meiragtx Holdings plc is heading for its first marketing approval following the successful treatment of 11 children with Leber amaurosis, a severe form of congenital retinal dystrophy that rendered them blind at birth. The 11 children, aged between 1 and 4 years old, all gained visual acuity following a single delivery of a correct version of the AIPL1 (aryl-hydrocarbon interacting protein-like1) gene, which codes for a photoreceptor protein in the cones and rods.
The lung and thrombosis may play a key role in cancer and metastasis progression, according to a collaborative study led by Cornell University scientists.
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