Industry News

Adamis Pharmaceuticals Provides Update on Clinical Study Assessing Tempol for the Treatment of COVID-19

08/03/2022

Interim DSMB review expected in late September Excerpt from the Press Release: SAN DIEGO, July 29, 2022 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an update on the Company’s ongoing U.S. Phase 2/3 clinical trial to evaluate the safety and efficacy of Tempol as a treatment for COVID-19. The next Data Safety Monitoring Board…

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National Cancer Institute Prostate Cancer Screening Study Indicates QTscan® Has Equal or Better Sensitivity Than MRI

08/03/2022

Excerpt from the Press Release: NOVATO, Calif., July 28, 2022 /PRNewswire/ — QT Imaging, Inc., a medical device company focused on the development and clinical adoption of novel products for body imaging, today announced results of a National Cancer Institute study comparing the QTscan with 7-Tesla MRI for prostate cancer screening. In an initial series of 10 patients,…

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Ionis announces enrollment completion of Phase 3 Lp(a) HORIZON cardiovascular outcomes study of pelacarsen

08/02/2022

Pelacarsen is a potentially first-in-class treatment specifically targeting elevated lipoprotein(a) (Lp(a)), an independent, inherited and causal risk factor for cardiovascular disease There are currently no approved pharmacological therapies to effectively lower Lp(a), which cannot be effectively addressed by diet and other lifestyle changes Topline results expected 2025 Excerpt from the Press Release: CARLSBAD, Calif., July 20, 2022 /PRNewswire/ — Ionis Pharmaceuticals,…

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Belite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease

08/02/2022

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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HyBryte™ Phase 3 FLASH Study for the Treatment of Cutaneous T-Cell Lymphoma Published in JAMA Dermatology

08/01/2022

Published findings demonstrate that HyBryte™ treatment statistically significantly reduced CTCL lesion size HyBryte™ has potential to address a critical gap in treatment of early-stage CTCL Excerpt from the Press Release: PRINCETON, N.J., July 20, 2022 /PRNewswire/ — Soligenix, Inc. (NASDAQ: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where…

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Bristol Myers Squibb Teams Up with Jack and Jill of America Inc. to Expand Tomorrow’s Innovators Program to Increase Black Representation in the Healthcare Industry

08/01/2022

Collaboration to kick off at “The Power of a Dream” National Convention in Orlando, Fla. to bridge professional diversity gaps to emphasize importance of health equity for communities of color Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb NYSE (BMY) announced the first biopharma three-year exclusive collaboration with the premier African American Family Organization,…

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Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for LAG-3-Blocking Antibody Combination Opdualag (nivolumab and relatlimab) for Treatment of Patients with Unresectable or Metastatic Melanoma

07/28/2022

Approval recommended for first-line treatment of advanced melanoma patients with tumor cell PD-L1 expression < 1% Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled median progression-free survival compared to nivolumab monotherapy If approved, it would…

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Vericel Announces Publication of Positive Results from Retrospective Study by the Burn and Reconstructive Centers of America (BRCA) of Patients with Large Posterior Trunk Burns Treated with Epicel

07/28/2022

Data published in the Journal of Burn Care & Research show 83% of patients with posterior burns (mean total body surface area of 56%) had successful engraftment of Epicel after one or two applications 90% survival rate following Epicel and/or Epicel plus split thickness skin graft Study demonstrates that standardized treatment protocols and surgical plans for…

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MediciNova Initiates Clinical Evaluation of a New Parenteral Formulation of MN-166 (ibudilast)

07/27/2022

Excerpt from the Press Release: LA JOLLA, Calif., July 21, 2022 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the initiation of a first-in-human clinical study to evaluate the pharmacokinetics and bioavailability of…

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CHMP Adopts Positive Opinion Recommending Veklury® (Remdesivir) Receive Full Marketing Authorization for the Treatment of Patients With COVID-19

07/27/2022

— If Granted by the European Commission, Veklury will Become the Only Direct-Acting Antiviral with Full Marketing Authorization in the EU — Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Commission (EC) adopted a positive…

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