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Sana Biotechnology Reports Clinical Data on UP421 in Type 1 Diabetes
Shots: Sana has reported 14mos. follow-up data from a FIH study of UP421, a hypoimmune-engineered allogeneic islet cell therapy, transplanted into a patient with Type 1 Diabetes without immunosuppression  Results showed sustained survival & function of pancreatic β cells. At 14mos., fasting & MMTT C-peptide levels matched the first 6mos. & exceeded in mos. 9-12,…
5 hours ago
Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa
Shots: The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…
10 hours ago
Samsung Bioepis and Epis NexLab Collaborate with G2GBIO on Long-Acting Semaglutide Development
Shots: Samsung Bioepis & Epis NexLab have entered a research collaboration & license agreement with G2GBIO to develop novel therapeutics using proprietary microsphere-based sustained-release technology As per the deal, Samsung Bioepis will receive full licensing rights to a long-acting Semaglutide asset, an option to license another asset, & first negotiation rights for three additional assets,…
11 hours ago
GSK
GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease
Shots: The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing immune response & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was…
3 days ago
Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria
Shots: OLE study assessed repinatrabit (JNT-517) in adolescents with PKU. Early time-point data remain embargoed to preserve parent-study blinding, with additional randomized-period results to be presented later First cohort receiving repinatrabit (75mg, PO, BID) showed a 67% mean reduction in Phe from baseline (Day 56/OLE Month 1), with responses seen in all pts, incl. prior…
3 days ago
Enodia Acquires Kezar’s Sec61 Program to Advance Targeted Protein Degradation Pipeline
Shots: Enodia has acquired Kezar’s Sec61-based discovery & development program assets, strengthening its understanding of Sec61 selectivity mechanisms & expanding translational insights to accelerate progress toward key clinical milestones As per the deal, Kezar will receive a $1M upfront, ~$127M in development, regulatory, & commercial milestones, plus tiered royalties on future net sales Enodia’s platform…
3 days ago
PRISM BioLab and Receptor.AI Partner to Develop a Drug Discovery Platform
Shots: PRISM has partnered with Receptor.AI to develop an AI-navigated, physics-guided platform for discovering orally available small molecules targeting intracellular protein–protein interactions (PPIs), membrane proteins & complex receptor systems Collaboration will combine PRISM’s PepMetics Tech, 3D small molecules designed to mimic α-helix & β-turn motifs, with Receptor.AI’s AI-driven molecular design engine to identify hit, lead, &…
3 days ago
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