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Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

03/02/2022

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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Merlin Test reduces unnecessary surgeries and associated complications for melanoma patients

03/01/2022

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 AND FULGENT GENETICS COLLABORATE TO DELIVER DefineMBC™ RESULTS FOR METASTATIC BREAST CANCER PATIENTS

03/01/2022

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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Pliant Therapeutics Announces Positive DSMB Safety Review and Commencement of Enrollment of Phase 2a Trial of PLN-74809 at 320 mg Dose in Idiopathic Pulmonary Fibrosis

03/01/2022

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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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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