MORRISTOWN, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) -- The Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) met today to discuss Intercept’s supplemental New Drug Application (sNDA) for OCALIVA® (obeticholic acid, OCA) for the treatment of primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. The sNDA was submitted to support full approval of OCALIVA and to satisfy post-marketing requirements confirming a clinical benefit in patients with PBC.

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Company Statement on FDA Advisory Committee Meeting  

- Clinically meaningful objective response rate (ORR) of 63.3-76.7% observed with belrestotug + dostarlimab combinations, with confirmed ORR (cORR) at ~60% for every dose- >30% cORR difference between belrestotug + dostarlimab vs dostarlimab monotherapy- Belrestotug + dostarlimab safety profile broadly consistent with known safety profile of checkpoint inhibitor combinations- GALAXIES Lung-301, global Phase 3 registration study, enrolling in same indication and setting- iTeos to host a conference call on Monday, September 16, 2024 at 8:00am ET

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iTeos Announces Clinically Meaningful Objective Response Rate Observed at Every Dose in Follow-up Interim Analysis of GALAXIES Lung-201 Study of...

-- Study Meets Overall Response Rate Primary Endpoint, Encouraging Secondary Endpoint Progression-Free Survival Data in Squamous Cell Carcinoma of the Head and Neck Cohort ---- No New Safety Signals or Added Systemic Safety Concerns Observed --

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IO Biotech Announces Positive Results from Phase 2 Trial of IO102-IO103 in the First-line Treatment of Advanced Head and Neck Cancer

Giralt on MDS Transplant Timing and Candidacy  Targeted Oncology

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Giralt on MDS Transplant Timing and Candidacy - Targeted Oncology

Aging is associated with functional and molecular changes in distinct hematopoietic stem cell subsets  Nature.com

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Aging is associated with functional and molecular changes in distinct hematopoietic stem cell subsets - Nature.com

A practical guide to therapeutic drug monitoring in busulfan: recommendations from the Pharmacist Committee of the European Society for Blood and Marrow Transplantation (EBMT)  Nature.com

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A practical guide to therapeutic drug monitoring in busulfan: recommendations from the Pharmacist Committee of the European Society for Blood and...

ISU researcher blown away by blood cell replication discovery  Radio Iowa

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ISU researcher blown away by blood cell replication discovery - Radio Iowa

Pausing biological clock could give boost to lab-produced blood stem cells  Phys.org

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Pausing biological clock could give boost to lab-produced blood stem cells - Phys.org

9-year-old gets successful bone marrow transplant  The Times of India

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9-year-old gets successful bone marrow transplant - The Times of India

Dr. Crandall: Stem Cell Treatment Heals the Heart  Newsmax

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Dr. Crandall: Stem Cell Treatment Heals the Heart - Newsmax

Company announcement – No. 42 / 2024

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Total number of shares and voting rights in Zealand Pharma on August 30, 2024

- Based on a per-protocol interim analysis of safety and efficacy data, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue without modifications- No new safety signals observed at interim analysis- Primary endpoint of progression free survival projected to be reached in the first half of 2025

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IO Biotech Updates on Pivotal Phase 3 Trial of IO102-IO103 in Combination with KEYTRUDA® (pembrolizumab) as a First-Line Treatment for Patients with...

All dollar amounts reflected in Canadian dollars unless otherwise stated.

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Rakovina Therapeutics Announces 2024 Q2 Financial Results and Provides Corporate Update

August 30, 2024

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Receipt of Nasdaq Delisting Determination - Plans to Appeal

Proceeds to be used for development of lead compound tuspetinib in combination therapy as frontline treatment for newly diagnosed AML patients Proceeds to be used for development of lead compound tuspetinib in combination therapy as frontline treatment for newly diagnosed AML patients

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Aptose Receives $10 Million Through a Facility Agreement with Hanmi; Negotiating Future Collaboration Agreement with Hanmi to Jointly Develop...

SHANGHAI, Aug. 30, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its 2024 interim financial results and provided corporate updates.

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Junshi Biosciences Announces 2024 Interim Financial Results and Provides Corporate Updates

George Medicines demonstrates potential of novel, low-dose, triple combination pill to transform management of hypertension in Hot Line Session at ESC Congress 2024

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George Medicines demonstrates potential of novel, low-dose, triple combination pill to transform management of hypertension in Hot Line Session at ESC...

SAN DIEGO, Sept. 01, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that its board of directors has appointed Hendrik P. N. Scholl, MD, MA, as the Chief Medical Officer of the Company, effective immediately. Dr. Scholl is the foremost globally recognized authority on Stargardt disease and age-related macular degeneration (AMD), bringing decades of expertise in treating retinal diseases, including the two key indications targeted by Belite Bio's lead drug candidate, Tinlarebant.

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Belite Bio Announces Appointment of Hendrik P. N. Scholl, MD, MA, as Chief Medical Officer

Tokyo, Japan and Cambridge, UK, 2 September 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – announces that it will receive a US$35 million payment from Neurocrine Biosciences (‘Neurocrine’), triggered by the successful completion of the Phase 2 trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia, as announced on 28 August 2024. Receipt of the US$35 million payment will be recognized as one-time revenue in the third quarter of 2024.

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Nxera Pharma to Receive US$35 Million from Neurocrine Biosciences upon Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568

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Press Release: Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in...