Biotechnology

Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy

05/23/2022

Pre-IND meeting request granted by FDA’s Division of Neurology I Excerpt from the Press Release: BOSTON, May 12, 2022 /PRNewswire/ — Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that the US Food and Drug Administration (FDA) Office of Orphan…

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Protagonist Therapeutics Announces Topline Data from Phase 2 IDEAL Study of PN-943 in Ulcerative Colitis

05/05/2022

PN-943 achieved 27.5% clinical remission with a delta of 13% versus placebo, with strong concordance across all key proxies including histological and endoscopic endpoints for efficacy, in the twice daily 150 mg dose arm Achieved clinical proof-of-concept and validation for oral, gut-restricted approach for ulcerative colitis via blockade of the alpha-4-beta-7-integrin pathway  Plans underway for…

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DCN Dx Acquires Microbiological Testing Products Company Biomed Diagnostics

05/04/2022

Excerpt from the Press Release: CARLSBAD, Calif., April 25, 2022 /PRNewswire/ — DCN Dx, a global leader in the end-to-end development, manufacture, and commercialization of point-of-use tests, today announced it has completed its acquisition of Biomed Diagnostics, Inc., a microbiological testing products company based in White City, Oregon. The acquisition expands DCN Dx’s footprint in the point-of-use testing…

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BeiGene Provides Grant to Crossroads4Hope to Fund Psychosocial Support Programs for Cancer Patients and Communities in New Jersey

04/29/2022

Excerpt from the Press Release: HOPEWELL, N.J. & CAMBRIDGE, Mass. & BASEL, Switzerland & BEIJING–(BUSINESS WIRE)–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, and Crossroads4Hope, A Network of Cancer Support, a 501(c)(3) organization committed to transforming the cancer experience for patients and their families…

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OncXerna Therapeutics Announces Journal of Clinical Oncology Publication Featuring Phase 1b Data of Navicixizumab Plus Paclitaxel in Ovarian Cancer

04/26/2022

Overall response rate (ORR) of 43% and median duration of response of 6 months seen with navicixizumab-paclitaxel combination in heavily pretreated platinum-resistant ovarian cancer patients Xerna™ TME Panel shows enhanced response in biomarker positive (62%) vs. biomarker negative patients (25%) Results support co-development of navicixizumab and Xerna TME Panel in ovarian cancer Excerpt from the…

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Oncolytics Biotech® Announces Publication of Preclinical Data Demonstrating the Synergistic Anti-Cancer Activity of Pelareorep Combined with CAR T Cell Therapy in Solid Tumors in Science Translational Medicine

04/25/2022

– Pelareorep-CAR T combination may expand the commercial potential of CAR T cells to solid tumors – Combining CAR T cells with pelareorep prevented antigen escape by creating CAR T cells with dual specificity through a novel mechanism – Loading CAR T cells with pelareorep led to dramatic improvements in their persistence and anti-cancer activity as…

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T-knife Therapeutics Announces New TCR-T Program Targeting KRAS G12V and Presents Data at the American Association for Cancer Research (AACR) Annual Meeting

04/18/2022

Excerpt from the Press Release: SAN FRANCISCO, April 08, 2022 (GLOBE NEWSWIRE) — T-knife Therapeutics, Inc., a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, today announced it is advancing its second TCR-T program, TK-2504, toward the clinic and presented preclinical data on its ability to generate novel TCRs targeting the KRASG12V antigen. The…

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Akston Biosciences Doses First Volunteers in Phase II/III Clinical Trial of Low Cost, Shelf Stable COVID-19 Vaccine

04/15/2022

1,500 healthy volunteers to participate in a Phase II/III double-blind placebo-controlled study in India Study results to be submitted for Emergency Use Authorization (EUA) Vaccine is shelf stable for over six months at room temperature at 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit) Excerpt from the Press…

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Proof Diagnostics Submits Request For Emergency Use Authorization Seeking First Approval Of Crispr-based Molecular Point-of-care Covid-19 Test

04/14/2022

If authorized by the FDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for COVID-19 (SARS-CoV-2) in as little as 18 minutes Excerpt from the Press Release: CAMBRIDGE, Mass., April 7, 2022 /PRNewswire/ — Proof Diagnostics, Inc., an innovative healthcare technology company delivering innovative solutions in molecular diagnostics, today announced the submission…

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BriaCell advances preparatory work for new Bria-OTS™ breast cancer clinical trial

04/14/2022

Bria-OTS™ would build on BriaCell’s existing clinical trial data with Bria-IMT™, treating each patient with the optimized pre-manufactured Bria-OTS™ formulation based on HLA-type. BriaCell and National Cancer Institute collaborating on Bria-OTS™, BriaCell’s off-the-shelf personalized immunotherapy, as a treatment for cancer. BriaCell to present Bria-OTS™ approach at the American Association for Cancer Research (AACR) Annual Meeting 2022. Excerpt from the…

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