|
Marcus' Biotech Briefing
Distilled Bio uses AI to process and generate content for you. Verify important details using the linked sources.
AI-generated briefing: EMA sets evidence standards for blood-disorder drugs, Minaris and Asimov target stronger AAV manufacturing, and REGENXBIO reports durable diabetic retinopathy results.
The top 10 stories from Thu Sep 24, 2026 06:47 AM to Fri Sep 25, 2026 06:47 AM
Generated September 25, 2026 at 6:47 AM
|
|
|
#1 Network Bio: Building disease-specific AI models with biobank data Published 2026-09-25 Palo Alto-based Network Bio uses patient-derived tissue biobank data to develop disease-specific AI models aimed at tracking disease progression and enabling earlier detection and treatment. Covered by: biocentury.com |
#2 Endpoints, Study Duration: EMA Sets Out Evidence Bar For Sickle Cell, Thalassemia Drug Approvals Published 2026-09-24 The EMA outlined evidence requirements, including study endpoints and duration, for approving drugs targeting sickle cell disease and thalassemia. Covered by: insights.citeline.com |
#3 STAT+: Kyverna’s cell therapy shows lasting autoimmune benefit Published 2026-09-24 Kyverna’s cell therapy demonstrated lasting benefits in autoimmune disease, while Elizabeth Holmes may leave prison early, according to the article. Covered by: statnews.com, endpoints.news, biospace.com |
#4 REGENXBIO Presents Positive Three-Year Durability Data for Surabgene Lomparvovec in Diabetic Retinopathy at Retina Society Annual Scientific Meeting Published 2026-09-25 REGENXBIO reported three-year data showing most Dose Level 3 participants with NPDR achieved over two-step DRSS improvement after one-time surabgene lomparvovec treatment, without vision-threatening events or additional retinopathy treatment. Covered by: prnewswire.com |
#5 Sarepta to pay Regenxbio $39M to settle gene therapy claims; Vida eyes fourth fund Published 2026-09-24 Sarepta Therapeutics agreed to pay Regenxbio $39 million to settle gene therapy claims, while Vida Ventures reportedly plans a fourth fund. Covered by: endpoints.news |
#6 ‘Not A Numbers Game’: EMA Pushes Back On US FDA’s Single Pivotal Trial Default Standard Published 2026-09-24 The EMA argues pivotal drug approvals should not default to a single trial when multiple studies address distinct scientific questions. Covered by: insights.citeline.com |
#7 Sobi to present clinical data on Gamifant® at Histiocyte Society 2026 in Rotterdam Published 2026-09-24 Sobi will present new clinical data on Gamifant (emapalumab) for primary haemophagocytic lymphohistiocytosis at the Histiocyte Society’s 2026 meeting in Rotterdam. Covered by: prnewswire.com |
#8 Minaris and Asimov Partner to Advance AAV Manufacturing with OXGENE Technology Published 2026-09-24 Minaris and Asimov will integrate OXGENE technology into Asimov’s AAV Edge producer cell lines to improve manufacturing titers and product quality. Covered by: prnewswire.com |
#9 Alexion Aims To Enter Crowded gMG Space With Convenience Advantage For Gefurulimab Published 2026-09-24 AstraZeneca’s Alexion will present 52-week gefurulimab data next week while awaiting FDA review; the drug has Japanese approval and a positive EMA CHMP recommendation. Covered by: insights.citeline.com |
#10 Altruist Biologics’ Suzhou Site Receives EMA GMP Certification Published 2026-09-24 Altruist Biologics’ Suzhou facility passed its first EMA GMP inspection with zero critical findings, supporting an EU marketing authorization application for a client’s biologics product. Covered by: genengnews.com |
