Industry

Sensorion Receives Positive Opinion for Orphan Drug Designation for OTOF-GT for the Treatment of Otoferlin Gene-Mediated Hearing Loss From the European Medicine Agency

MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News: Sensorion (FR0012596468 – ALSEN) (Paris:ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion on Sensorion’s application … [Read more…]

Triumvira Immunologics Presents Initial HER2-Positive Solid Tumor Clinical Data at ESMO

Early signals of clinical activity observed in second dosing cohort with one partial response TAC01-HER2 was safe and well-tolerated in the first two dosing cohorts of TACTIC-2 Phase 1/2 clinical trial AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics (“Triumvira”), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural … [Read more…]

Cellusion and Celregen, a member of Fosun Pharma, Enter into Exclusive License Agreement of CLS001 for a Corneal Endothelial Cell Regenerative Therapy in the Greater China Region

Celregen Obtains the Exclusive Rights to Develop, Manufacturing and Commercialize CLS001 in Greater China Region; Cellusion Retains Other Regional Rights. The Deal is Worth up to over $100 Million, including Upfront, Development and Sales Milestone Payments, and Tiered Royalties. TOKYO & HANGZHOU, China & SHANGHAI–(BUSINESS WIRE)–Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., “Cellusion”), a Japanese … [Read more…]

Edgewise Therapeutics Announces Positive 4-Month Interim Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker Muscular Dystrophy (BMD)

– Remarkable North Star Ambulatory Assessment scale (NSAA) improvements relative to BMD natural history trajectories – – Significant decrease in levels of serum creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), enzyme biomarkers strongly associated with muscle damage caused by BMD – – EDG-5506 continues to be well-tolerated with no serious adverse events observed – – … [Read more…]

CORRECTING and REPLACING GRAIL Announces Final Results From the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022

  MENLO PARK, Calif.–(BUSINESS WIRE)–Please replace the release with the following corrected version. A multimedia asset accompanying this release and paragraph seven have been removed. The updated release reads: GRAIL ANNOUNCES FINAL RESULTS FROM THE PATHFINDER MULTI-CANCER EARLY DETECTION SCREENING STUDY AT ESMO CONGRESS 2022 Adding Multi-Cancer Early Detection (MCED) Screening to Standard of Care … [Read more…]

Homelessness: AHF Uncovers Thousands of Vacant SRO Hotel Rooms Across L.A.

In a new L.A. Times ad (Sunday, September 11), AHF’s Housing Is A Human Right highlights results of its recent investigation and tally revealing 4,612 hotel rooms throughout Los Angeles that could be repurposed as housing for homeless and extremely-low-income individuals An average of 1,500 unsheltered or homeless individuals die on the streets of Los … [Read more…]

GRAIL Announces Final Results From the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022

Adding Multi-Cancer Early Detection (MCED) Screening to Standard of Care Screening More Than Doubled the Number of Cancers Detected 71% of Participants With MCED-Detected Cancers Had Cancer Types With No Routine Screening Tests Available Approximately Half of the MCED-Detected New Cancers Were Stage I or II MCED-Predicted Cancer Signal Origin Had 97.1% Accuracy and Enabled … [Read more…]

Clovis Oncology’s Rubraca® (Rucaparib) as First-Line Maintenance Treatment Improves Progression-Free Survival in Women with Advanced Ovarian Cancer Across Disease Risk Subgroups

Subgroup analysis from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented in a Mini Oral session at the ESMO Congress 2022 Results reinforce potential of Rubraca as a first-line maintenance treatment option in a broad population of patients with ovarian cancer irrespective of molecular characteristics, with or without high risk factors … [Read more…]

ENHERTU® (fam-trastuzumab deruxtecan-nxki) Continues to Demonstrate Clinically Meaningful Tumor Response in Patients with HER2-mutant Metastatic Non-small Cell Lung Cancer

DESTINY-Lung02 Phase II trial shows clinically meaningful efficacy and favorable safety at 5.4mg/kg vs. 6.4mg/kg dose of AstraZeneca and Daiichi Sankyo’s ENHERTU in HER2-mutant disease Updated results from DESTINY-Lung01 Phase II trial demonstrate continued durable activity across patient subtypes WILMINGTON, Del.–(BUSINESS WIRE)–Detailed positive results from an interim analysis of the DESTINY-Lung02 Phase II trial showed … [Read more…]

IMFINZI® (durvalumab) and tremelimumab with chemotherapy demonstrated sustained survival benefit in metastatic non-small cell lung cancer, nearly doubling the number of patients alive after three years vs. chemotherapy

Exploratory analysis from POSEIDON Phase III trial also showed trends for overall survival benefit with a limited course of tremelimumab added to IMFINZI and chemotherapy in subgroups with high unmet need WILMINGTON, Del.–(BUSINESS WIRE)–Updated results after approximately four years of follow-up of the POSEIDON Phase III trial showed a limited course of tremelimumab when added … [Read more…]