Industry News
Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma If approved by the European Medicines Agency, KIMMTRAK will be the first and only treatment option approved in Europe to treat patients with unresectable or metastatic uveal melanoma KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months Excerpt from the…
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Excerpt from the Press Release: ROTTERDAM, Netherlands and SAN DIEGO, Feb. 24, 2022 /PRNewswire/ — Today, SkylineDx announced that their Merlin Test for melanoma patients would have been able to reduce over 59% of surgery-related complications by means of deselecting patients for surgery [2]. The commercially available Merlin Test identifies melanoma patients that can safely forgo a sentinel lymph node…
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Epic Sciences scales its workflow for ctDNA testing with Next Generation Sequencing Leader Fulgent Fulgent Genetics’ expertise in high-volume testing powers Epic’s Comprehensive Cancer Profiling Excerpt from the Press Release: SAN DIEGO, Feb. 24, 2022 /PRNewswire/ –Epic Sciences, Inc. today announced it has partnered with Fulgent Genetics (NASDAQ:FLGT) to deliver DefineMBC comprehensive profiling results for metastatic breast…
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Recent independent Data Safety Monitoring Board (DSMB) review recommended the INTEGRIS-IPF Phase 2a trial continue without modification and proceed to evaluate dosing at 320mg Trial initiation follows the FDA authorization of evaluation of long-term dosing of PLN-74809 at doses up to 320 mg in IPF patients Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Feb.…
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38-month median follow-up data from the Phase III JAVELIN Bladder 100 trial demonstrated prolonged median OS of 23.8 months with BAVENCIO plus best supportive care (BSC) in the first-line maintenance setting versus a median OS of 15.0 months with BSC alone BAVENCIO continues to be the first and only immunotherapy to improve survival in the…
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OVATION 2 Study is Over 75% Enrolled; Full Enrollment Expected by Mid-2022 Novel Gene-Mediated Immunotherapy is Safe and Demonstrates an Acceptable Risk/Benefit When Administered Over a Six-Month Period Excerpt from the Press Release: LAWRENCEVILLE, N.J., Feb. 17, 2022 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that following a pre-planned interim safety review of 81 as treated patients…
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Electroencephalography data (EEG) demonstrate enhancement of brain activity specific to attention function in children 8-12 with ADHD following AKL-T01 (EndeavorRx) treatment Data show correlation between targeted activity in the brain and objective improvements in attention function Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics…
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EDP-938 is Currently Being Evaluated in Phase 2 Studies in Pediatric Patients and Hematopoietic Stem Cell Transplant Recipients With RSV On Track to Report Topline Data from RSVP, a Phase 2b Study in Adults with Community-Acquired RSV Infection, in the Second Quarter of 2022 Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA),…
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Evelo Biosciences Announces Dosing of First Patient in Phase 2 Trial of EDP1815 in Atopic Dermatitis
Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 17, 2022 (GLOBE NEWSWIRE) — Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing SINTAX™ medicines as a new modality of orally delivered treatments for inflammatory disease, today announced that the first patient has been dosed in EDP1815-207, its Phase 2 randomized clinical trial of EDP1815…
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Neumora to develop and commercialize M4-selective muscarinic receptor positive allosteric modulator program for schizophrenia and other neuropsychiatric disorders Neumora gains two novel series of M4 receptor modulator compounds in late preclinical development Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Neumora Therapeutics, Inc. (Neumora), a clinical-stage biotechnology company pioneering precision medicines for brain diseases through the…
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