News & Updates

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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VERACYTE ANNOUNCES NEW CLINICAL VALIDATION DATA FOR RNA SEQUENCING-BASED AFIRMA MEDULLARY THYROID CANCER CLASSIFIER PUBLISHED IN THYROID

07/29/2022

The Genomic Test Demonstrated 100 Percent Sensitivity and 100 Percent Specificity for MTC Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Jul. 20, 2022– Veracyte, Inc. (Nasdaq: VCYT) today announced that new clinical validation data published online in Thyroid show that the company’s RNA sequencing-based Afirma Medullary Thyroid Cancer (MTC) Classifier demonstrated high sensitivity and specificity in identifying…

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New Collaborative Research Study Between nference and the NIH Identifies Which Mutations Enable Highly Transmissible Viruses, Like SARS-CoV-2, to Persist in Human Circulation

07/29/2022

Published in PNAS Nexus, this study has the ability to impact future research and inform more proactive and sustainable pandemic preparedness Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–nference, an AI-driven health technology company, today announced a new research partnership following the publication of a study demonstrating the value of characterizing SARS-CoV-2 viral sequences using…

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Blue Lake Biotechnology Announces First Participant Dosed in a Phase 1 Clinical Trial of Its BLB-201 Intranasal RSV Vaccine

07/29/2022

Excerpt from the Press Release: ATHENS, Ga. and LOS GATOS, Calif., July 21, 2022 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced the enrollment of the first participant in a Phase 1 clinical trial of their intranasal BLB-201 vaccine for RSV (respiratory syncytial virus)…

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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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