FDA
Novel Phase 3 Trial Design to Evaluate Bemnifosbuvir as Monotherapy and Combination Antiviral Therapy for COVID-19 Trial to Focus on High-Risk Patients at Greatest Risk for Disease Progression Trial Expected to Initiate in Fourth Quarter 2022 Conference Call at 8:30 a.m. ET Today Excerpt from the Press Release: BOSTON, Sept. 13, 2022 (GLOBE NEWSWIRE) —…
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— Company Expects to Announce Topline Data from Study in Adults 65 Years and Older in the First Half of 2023 — — Vaxcyte Remains on Track to Announce Topline Data from the Phase 1 and Phase 2 Portions of the VAX-24 Proof-of-Concept Study in Adults Aged 18-64 in October or November 2022 — —…
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This study will evaluate Abecma in patients with suboptimal response to transplant Data from KarMMa-3 and KarMMa-2 studies of Abecma will be presented at future medical meeting Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–2seventy bio, Inc. (Nasdaq: TSVT) today announced plans to initiate the KarMMa-9 study to evaluate Abecma (idecabtagene vicleucel) in newly diagnosed…
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mRNA-1273.222 Targets BA.4/BA.5 Strains of Omicron Variant Pending Authorization, Moderna Ready to Ship Bivalent Booster mRNA-1273.222 in September Clinical Data Available for Moderna’s Bivalent COVID-19 Booster Vaccines Have Met All Primary Endpoints and Support Request for Emergency Use Authorization Excerpt from the Press Release: CAMBRIDGE, MA / ACCESSWIRE / August 23, 2022 / Moderna, Inc.…
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Excerpt from the Press Release: BOSTON and ATLANTA, Aug. 26, 2022 /PRNewswire/ — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that the U.S. Food and Drug Administration (FDA)…
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The first-of-its-kind, CRISPR-based therapeutic aims to stop the progression of Duchenne muscular dystrophy in a single-patient dosing Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Cure Rare Disease (CRD) – a Boston-based 501c3 nonprofit biotech – announces the approval from the U.S. Food and Drug Administration (FDA) to administer its very first therapeutic. The drug, named CRD-TMH-001, treats…
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Company to Move Forward with Key U.S. Regulatory Applications – Investigational New Drug and Orphan Drug Designation BOSTON, July 26, 2022 (GLOBE NEWSWIRE) — Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist…
Read More – 200mg and 400mg Once-Daily Doses Achieved Strong Exposure Multiples Over EC90 and Were Generally Safe and Well-Tolerated – Plan to Initiate Phase 2 Study in 4Q 2022 Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections and liver…
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Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital Excerpt from the Press Release: NEWTON, Mass. and GENEVA, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today…
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LBS-008 (a/k/a Tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease (STGD1) There are currently no approved treatments for STGD1 Approximately 30,000 patients in the U.S. suffer from STGD1 A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing The Phase 3,…
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