FDA
Further data from Phase 1 study in healthy older adults demonstrate improved tolerability profile of LYT-100 compared to pirfenidone Data support the planned LYT-100 dose-ranging registration-enabling studies in idiopathic pulmonary fibrosis, with topline results expected in 2023 Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage…
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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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The ELI-002 and Libtayo® combination will be studied in KRAS-driven tumors including Stage III and IV non-small cell lung cancer (NSCLC), Stage IV colorectal cancer (CRC) and unresectable, locally advanced or oligometastatic pancreatic ductal adenocarcinoma (PDAC) Excerpt from the Press Release: BOSTON, May 16, 2022 (GLOBE NEWSWIRE) — Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline…
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SP-102 (SEMDEXATM) is the first non-opioid novel injectable corticosteroid gel formulation product in development for the treatment of lumbar radicular pain, and it contains no preservatives, surfactants, solvents, or particulates. The study met its primary endpoint with a highly statistically significant reduction in average daily leg pain in patients receiving SEMDEXATM compared to placebo (p<0.001).…
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Excerpt from the Press Release: NEWTOWN, Pa., May 5, 2022 /PRNewswire/ — Sen-Jam Pharmaceuticals and KVK Tech are collaborating to develop a Covid-19 oral therapy. The companies will operate in parallel while they complete the Phase II clinical trials in Nepal. KVK Tech will offer formulation and chemistry, manufacturing and controls (CMC) for the oral therapy. Furthermore, KVK…
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Based on positive feedback provided by FDA on key clinical design details Jasper plans to initiate registrational studies in AML and MDS patients Excerpt from the Press Release: REDWOOD CITY, Calif., April 28, 2022 (GLOBE NEWSWIRE) — Jasper Therapeutics, Inc., (NASDAQ: JSPR) a biotechnology company focused on hematopoietic stem cell therapies, today announced that after…
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Peer-reviewed results from the two-level multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF Excerpt from the Press Release: SAN DIEGO, April 21, 2022 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Disc (Simplify Disc) two-level U.S. Food…
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— Executive appointments position the company for continued growth and expansion — Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Truvian Sciences (“Truvian”) today announced four executive appointments that bring expanded industry and commercialization experience to the company as it advances toward submitting for U.S. Food and Drug Administration (FDA) clearance of its automated benchtop blood testing…
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Pre-exposure prophylaxis (prevention) trial reduced risk of symptomatic COVID-19, with no severe disease or COVID-19-related deaths in EVUSHELD group Data published in the New England Journal of Medicine Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s EVUSHELD™(tixagevimab and cilgavimab), formerly AZD7442, reduced…
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CMS I-neb® is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients with NCFB colonized with P. aeruginosa; NCFB is a chronic, progressive, and irreversible respiratory disease Breakthrough designation validates registrational path for CMS I-neb® in NCFB and facilitates potentially expedited development and review Excerpt from the Press Release: MILAN and BOSTON, April 21, 2022 /PRNewswire/ — Zambon, a…
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