FDA
Data to be Presented at Upcoming Annual ASRA Meeting Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics, today announced positive results from its recently completed pilot Phase 2 clinical trial of vocacapsaicin in patients undergoing open laparotomy for ventral hernia…
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Genentech Provides Update on Phase III SKYSCRAPER-02 Study in Extensive-Stage Small Cell Lung Cancer
SKYSCRAPER-02, the first randomized study of tiragolumab in extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival ES-SCLC is a hard-to-treat disease and Tecentriq plus chemotherapy remains a standard of care Tiragolumab continues to be evaluated in non-small cell lung cancer and other cancer types through additional Phase III…
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– First therapeutic candidate for the treatment of SSc-ILD targeting both key fibrotic and inflammatory pathways – – ATHENA-SSc-ILD Phase 2 topline results expected first-half 2024 – – FDA has granted Fast Track Designation for PRA023 for the treatment of SSc-ILD – Excerpt from the Press Release: SAN DIEGO, March 30, 2022 (GLOBE NEWSWIRE) —…
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Second largest study to date in COVID-19 outpatients (N=1,936) Highly superior compared to placebo, with a probability of superiority of 99.91% on the primary endpoint 60% reduced risk of COVID-19-related death Primary endpoint achieved across multiple SARS-CoV-2 variants, including omicron Eiger plans to submit data to FDA for Emergency Use Authorization (EUA) Management to host…
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Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as a companion diagnostic for a third group of targeted therapies Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, today announced it has received approval from the U.S. Food and Drug…
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Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression Excerpt from the Press Release: SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance…
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-One-Year Final Data Highlights Lead Cell Therapy Asset, CAP-1002, for Safety and Efficacy in Slowing Upper Limb and Cardiac Function Deterioration in Patients- -Data Sets Stage for Pivotal Phase 3 HOPE-3 Clinical Trial- Excerpt from the Press Release: SAN DIEGO, March 11, 2022 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development…
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Company expects to report interim safety and biomarker data for Cohort 1 patients in the global phase 1/ 2 clinical trial, GALax-C, by end of 2022 Excerpt from the Press Release: PHILADELPHIA, March 10, 2022 (GLOBE NEWSWIRE) — Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central…
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ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which Has Broad Potential Application Across a Variety of Solid Tumors and Hematologic Malignancies Phase 1 TRAVERSE Trial of ALLO-316 for the Treatment of Renal Cell Carcinoma (RCC) ongoing Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., March 10, 2022 (GLOBE NEWSWIRE) — Allogene…
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3D Vector ECG Collection Device Slated for FDA 510k Submission in the Fourth Quarter of 2022 Excerpt from the Press Release: SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, today announced it has signed a professional services agreement (the “Agreement”) with…
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