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Business
Jazz CEO calls on industry to help rebuild momentum for leadership diversity
The first-time CEO says her own sponsors took chances on her—and that industry leaders need to do the same to rebuild momentum for gender equity.
October 14, 2026
·
4 min read
·
Gabrielle Masson
Press Releases
OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis
• Recent U.K. MHRA Scientific Advice Meeting (SAM) that resulted in full alignment to initiate confirmatory Phase 3 trial in U.K. with existing Phase 2 drug product paved the way Conditional Marketing Authorisation Application (CMAA) submission in the coming weeks and Phase 3 trial initiation in mid Q4/'26 following Phase 2b drug product requalification • MHRA’s SAM participants’ recommendation to Project Orbis U.K. leadership to take the global regulatory leadership mantle with U.S. FDA and EMA, coupled with granting the Company access to U.K. national patient registry, the UK Clinical Practice Research Datalink (CPRD) to strengthen comparator data while Phase 3 is ongoing to further improve interpretability of data during early market access phase • Since 2021, 29 MHRA-led products have been approved by U.S. FDA via Project Orbis • Company continues to engage with U.S. FDA on the non-Orbis Accelerated Approval route after successful Type C Statistical Methods Meeting that resulted in alignment on amended Phase 3 study design as buildout of OST-400 natural history database expands to include U.K. national patient registry data and Company awaits FDA decisions on RMAT, Rolling Review and CNPV ahead of the pending Q4/'26 completion of its ongoing BLA filing initiated in Q1/'26 • BLAs granted via Project Orbis are eligible to receive Priority Review Vouchers (PRVs) and may also be granted via the Accelerated Approval Program • Patient previously reported as lost to follow-up confirmed to be alive
September 21, 2026
·
7 min read
Press Releases
Kairos Pharma Reports Positive, Statistically Significant Interim Efficacy Data from Phase 2 Trial of ENV-105 in Metastatic Prostate Cancer
October 6, 2026
·
3 min read
Press Releases
OS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma
• Meeting to occur in mid-September 2026 • Interim 3-year Overall Survival data expected early September, 2026 • Decisions on appropriate comparator arm to interpret OST-HER2 clinical efficacy, RMAT designation and Rolling Review expected following this meeting • Sustained overall survival benefit observed between 2-year and 2.5-year timepoints • U.K. MHRA Statistical Methods Scientific Advice Meeting granted in parallel
August 13, 2026
·
6 min read
Press Releases
Celea Therapeutics Presents SURPASS-IPF Phase 3 Trial Design and Statistical Considerations for Evaluating Clinical Trials in Idiopathic Pulmonary Fibrosis at the IPF Summit 2026
September 30, 2026
·
5 min read
Press Releases
Ansa Biotechnologies to Showcase Breakthrough DNA Synthesis Technology Backed by Industry’s Only On-Time Guarantee at SynBioBeta 2026 Conference
April 29, 2026
·
3 min read
Press Releases
OS Therapies Achieves Statistically Significant Final Three-Year Overall Survival Benefit for Herlystic(TM)-Treated Patients in Phase 2b Pulmonary Metastatic Osteosarcoma Trial
October 6, 2026
·
1 min read
Press Releases
Caliway Announces Positive Phase 2 Results of CBL-514 in Dercum’s Disease, Achieving Primary Endpoint with Statistically Significant and Sustained Pain Reduction
September 23, 2026
·
7 min read
Press Releases
Genmab and AbbVie Announce Epcoritamab in Combination with R-CHOP Demonstrates Statistically Significant Improvement in Progression-Free Survival in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma
October 5, 2026
·
13 min read
Press Releases
Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials
September 8, 2026
·
11 min read
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