News & Updates

Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

03/07/2024

Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies Follows ongoing clinical study of CLN-619 alone and in combination with pembrolizumab in solid tumors, with anticipated updated clinical data in Q2 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., March 01, 2024…

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BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

03/06/2024

Matching adjusted indirect comparison addresses key questions and limitations associated with previously presented analysis and suggests efficacy advantage of BRUKINSA vs acalabrutinib Excerpt from the Press Release: BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced a new matching adjusted indirect comparison (MAIC)…

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Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC

03/05/2024

– New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients – – Company discontinued the ONSEMBLE trial in August 2023 to shift focus of clinical development program to first-line RAS-mutated mCRC in agreement with the FDA – Excerpt…

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Alumis Presents Preclinical Data for Allosteric TYK2 Inhibitor A-005 at ACTRIMS

03/04/2024

– A-005 is a potential first-in-class, brain penetrant TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases –– Data support planned Phase 1 clinical trial on track to initiate in 1H 2024 – Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., March 1, 2024 – Alumis Inc., a clinical-stage biopharmaceutical company developing oral…

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Charles River and Wheeler Bio Complete Agreement to Accelerate the Journey from Discovery and CMC Development to Manufacturing

03/01/2024

Excerpt from the Press Release: WILMINGTON, Mass. & OKLAHOMA CITY–(BUSINESS WIRE)–Charles River Laboratories International, Inc. (NYSE: CRL) today announced a strategic agreement with Wheeler Bio, Inc., an antibody contract development and manufacturing organization (CDMO) focused on preclinical and early clinical supply of recombinant proteins, providing clients access to Wheeler’s Portable CMC® (Chemistry, Manufacturing and Controls)…

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Cogent Biosciences Announces Positive Part 1b Data from SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis

02/29/2024

Registration-enabling SUMMIT Part 2 initiated and actively enrolling at 40 sites globally; RP2D selected at 100 mg once-daily optimized formulation based on: Excerpt from the Press Release: WALTHAM, Mass. and BOULDER, Colo., Feb. 22, 2024 (GLOBE NEWSWIRE) — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today…

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Ocugen, Inc. Announces Dosing Completion of Subjects with Stargardt in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410ST

02/28/2024

Excerpt from the Press Release: MALVERN, Pa., Feb. 22, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 GARDian clinical trial for…

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A Guide To Selecting The Right Electronic Data Capture (EDC) Technology Vendor

02/27/2024

Selecting the Right EDC: A Critical Decision for Clinical Trial Success In the ever-evolving landscape of clinical trials, the choice of an Electronic Data Capture (EDC) technology vendor is more than a mere procedural step; it’s a pivotal decision that can significantly impact the success of your clinical research. Whether you’re embarking on your first…

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Neuraptive Therapeutics, Inc. Announces Positive 24-Week Data for NTX-001 in the Phase 2 NEUROFUSE Study, Reinforcing Previously Announced Proof of Concept 12-Week Data

02/27/2024

Excerpt from the Press Release: WAYNE, Pa.–(BUSINESS WIRE)–Neuraptive Therapeutics, Inc., a pioneer in nerve repair and regeneration, is proud to announce new 24-week data from the ongoing NEUROFUSE Study for NTX-001, further solidifying the product’s status following the previously announced proof of concept results based on the 12-week data in January 2024. The latest data…

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ProSomnus Reports Successful Pilot Study Validation of Next Generation Remote Patient Monitoring Device for Obstructive Sleep Apnea

02/26/2024

Excerpt from the Press Release: PLEASANTON, Calif., Feb. 22, 2024 (GLOBE NEWSWIRE) — ProSomnus, Inc. (NASDAQ: OSA) (the “Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced results of its pilot study for the Company’s Next Generation Remote Patient Monitoring (RPM) device for Obstructive Sleep Apnea (OSA). Data from the pilot study demonstrated that…

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