A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products.
Libtayo (cemiplimab-rwlc) became the first PD-1 therapy to score a phase III win in cervical cancer, a pleasing development not only for investors in Regeneron Pharmaceuticals Inc. and partner Sanofi SA but for patients with the stubborn disease.
LONDON – Targeted protein degradation (TPD) specialist Amphista Therapeutics Ltd. has delivered yet another demonstration of investor interest in the field, closing a $53 million series B.
HONG KONG –Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization.
DUBLIN – Immatics NV reported unexpected signs of efficacy in a first cut of data from several phase I trials of its autologous engineered T-cell therapies in heavily pretreated patients with recurrent or refractory solid tumors.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Algernon, Ambrx, Merck.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alessa, Erx, Eyenovia, GT, Harmony, Sage, Spruce, Versantis.
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