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Sorrento Announces FDA Authorization to Proceed With Phase 1 Study Of Intranasal STI-9199 (COVISHIELD), a Potent Neutralization Antibody Against Covid-19 Viruses

03/14/2022

FDA granted IND clearance today for STI-9199 (COVISHIELD™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers. Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients. STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the…

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BeiGene Announces Health Canada Approval for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Marginal Zone Lymphoma

03/11/2022

Follows U.S. approval for relapsed or refractory marginal zone lymphoma in 2021 Third approved indication for BRUKINSA in Canada, following mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia (WM) Excerpt from the Press Release: MISSISSAUGA, Ontario & CAMBRIDGE, Mass. & BEIJING & BASEL, Switzerland–(BUSINESS WIRE)–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company…

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ProMIS Neurosciences’ PMN310 antibody demonstrates significant cognitive benefit in a mouse model of Alzheimer’s disease

03/11/2022

Transgenic mouse model reflects latest scientific understanding of disease – toxic oligomers of amyloid create cognitive deficit Excerpt from the Press Release: ORONTO, Ontario and CAMBRIDGE, Mass., March 02, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as…

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ALX Oncology Announces First Patient Dosed in ASPEN-06, a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Cancer

03/11/2022

Phase 2/3 study initiated in collaboration with Eli Lilly and Company Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., March 02, 2022 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the first patient has been dosed…

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AmMax Bio Announces Positive Phase 2 Results Demonstrating Proof-of-Concept for the Novel Local Delivery of AMB-05X in Patients with Tenosynovial Giant Cell Tumor (TGCT)

03/10/2022

Intra-Articular Injection Strategy Shows Efficacy Across Multiple Clinical Endpoints and Favorable Safety Profile After 12 Weeks of Therapy   Data From the Phase 2 Study Support the Potential of AMB-05X as a Best-in-Class Therapy for Treatment of TGCT Excerpt from the Press Release: REDWOOD CITY, Calif., March 02, 2022 (GLOBE NEWSWIRE) — AmMax Bio, Inc. (“AmMax”),…

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PURIFY Investigators Announce First Patient Enrolled in a US Randomized Controlled IDE Trial Evaluating Seraph 100 for the Treatment of Septic Shock

03/10/2022

Excerpt from the Press Release: MARTINEZ, Calif.–(BUSINESS WIRE)–Investigators today announced the first patient enrollment in the Blood Purification for the Treatment of Pathogen Associated Shock (PURIFY-RCT) trial. PURIFY-RCT is a prospective interventional multicenter randomized controlled trial, sponsored by the Department of Defense in collaboration with the Henry M. Jackson Foundation and the Uniformed Services University of Health…

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HeartBeam Partners with Phoebe Putney Health System for First Pilot Study of Emergency Department Myocardial Infarction Software

03/10/2022

Business Associate Agreement and Clinical Trial Agreement with Additional Planned Studies and Commercial and Scientific Collaboration 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 Business Associate Agreement (BAA) and Clinical…

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Artelo Biosciences Receives Notice of Allowance for Method-of-Use Patent in the United States for ART12.11, a Proprietary Cocrystal of Cannabidiol

03/09/2022

Excerpt from the Press Release: SOLANA BEACH, Calif., March 02, 2022 (GLOBE NEWSWIRE) — Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, announced that the Company received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for…

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FDA Grants Breakthrough Device Designation for Dexcom Hospital CGM System

03/09/2022

Dexcom CGM to be evaluated for performance in the hospital and for the potential of more effective glycemic management and improved patient outcomes in the hospital setting Breakthrough Device Designation from the FDA is a critical milestone for in-patient Dexcom CGM use This designation provides a more efficient and streamlined review pathway so innovative Dexcom…

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Dragonfly Therapeutics Announces Achievement of Phase 1 Clinical Development Milestone for IL-12 Investigational Immunotherapy Program with Bristol Myers Squibb

03/09/2022

Dragonfly receives a milestone payment from Bristol Myers Squibb for progression of its Phase 1 DF6002-001 study with a PK profile and peripheral PD consistent with preclinical models Excerpt from the Press Release: WALTHAM, Mass., March 1, 2022 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly”) today announced the achievement of a Phase 1 clinical development milestone for the…

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