Month: February 2022

Ra Medical Systems Provides an Update on Enrollment in Its Pivotal Atherectomy Clinical Trial

02/28/2022

Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focused on developing its excimer laser system to treat vascular diseases, announces enrollment has reached 95 subjects in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy…

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Long-Term Follow-Up Data Reinforce Continued Overall Survival Benefit of BAVENCIO® (avelumab) First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma

02/28/2022

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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Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

02/28/2022

The percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142 Zeposia is the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved to treat patients with ulcerative colitis Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced interim results from the…

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Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

02/25/2022

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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PureTech Founded Entity Akili Announces PLOS ONE Publication of Clinical Study Results and EEG Data Showing Akili Digital Therapeutic EndeavorRx® Activates Systems in Brain Key to Attentional Functioning

02/25/2022

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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Enanta Pharmaceuticals Announces Publication in The New England Journal of Medicine of Data from the Phase 2a Human Challenge Study of EDP-938 for the Treatment of Respiratory Syncytial Virus (RSV)

02/25/2022

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

02/24/2022

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 Expands Precision Neuroscience Pipeline with Novel M4 Receptor Modulator Program Through Exclusive License Agreement with Vanderbilt University

02/24/2022

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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Repertoire® Immune Medicines Enters Research Collaboration With UMass Chan Medical School to Identify the Underlying Immune Causes of Vitiligo

02/24/2022

Research collaboration will utilize Repertoire’s DECODE™ platform to identify specific T cell receptors and antigens causing onset and progression of autoimmune disease vitiligo, with goal of developing targeted immunotherapy Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Repertoire Immune Medicines, Inc. today announced it has entered a sponsored research agreement with UMass Chan Medical School (UMass Chan)…

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U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Supplemental Biologics License Application for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma

02/23/2022

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years U.S. FDA has assigned a target action date of June 24, 2022 Excerpt from the…

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