Industry News

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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DICE Therapeutics Announces Completion of Enrollment in Phase 1 Clinical Trial of Lead Oral IL-17 Antagonist, DC-806, for the Treatment of Psoriasis

07/27/2022

Topline proof-of-concept data in healthy volunteers and psoriasis patients expected in 2H 2022 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., July 21, 2022 (GLOBE NEWSWIRE) — DICE Therapeutics, Inc. (Nasdaq: DICE), a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in…

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Revelation Biosciences Inc. Completes Database Lock for its Phase 1b CLEAR Clinical Study of REVTx-99b for the Treatment of Allergic Rhinitis

07/26/2022

-Topline Data expected in the last week of July- Excerpt from the Press Release: SAN DIEGO, July 14, 2022 (GLOBE NEWSWIRE) — Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on the development of immunologic‑based therapies for the prevention and treatment of disease, today announced data…

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Dialysis machine inspired by juice dispenser wins UK engineering prize

07/26/2022

Royal Academy of Engineering MacRobert award-winner could transform lives of kidney disease patients, say experts Excerpt from the Press Release: A home dialysis machine inspired by technology used in fruit juice dispensers has won the UK’s most prestigious engineering prize. The device, made by Quanta, is currently used by about 50 patients in the UK,…

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