BioSpace News Archive

PhaseV announced today it has partnered with oncology- and hematology-focused clinical research organization (CRO) iOMEDICO to launch a new virtual analytical framework solution for pharma and biotech companies that seek to optimize and de-risk phase 3 oncology clinical trials.

Lumicell, Inc today announced the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and Drug Administration (FDA) voted in support of the benefit-risk profile of LUMISIGHT™ (pegulicianine) during the March 5, 2024 meeting.

The current federal regulatory process to develop monoclonal antibodies to treat mutating strains of COVID-19 imposes unnecessary hurdles that hinder the creation and approval of effective treatments for the immunocompromised, finds a new brief released by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute.

Precision BioSciences, Inc. today announced that its partner iECURE has received approval from the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) for the company’s Clinical Trial Authorization (CTA) application to expand the Phase 1/2 OTC-HOPE study evaluating ECUR-506 into the U.K.

MAIA Biotechnology, Inc. today announced positive efficacy data for third-line treatment in its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment of venous disease, today announced the presentation of positive topline efficacy data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve at the 2024 American Venous Forum (AFV) Annual Meeting in Tampa, Florida.

Femasys Inc. announces the first commercial procedure using its FemaSeed intratubal insemination product.

ARS Pharmaceuticals, Inc. today announced its participation in the Leerink Partners Global Biopharma Conference 2024 being held March 11-13, 2024 in Miami, Florida.

ResMed announced the U.S. launch of the AirFit F40, an ultra-compact, full-face mask offering the comfort of smaller masks without sacrificing performance in order to help improve sleep apnea therapy compliance.

BIOXYTRAN, INC. announced the preprint in ResearchGate entitled “Association of Rapid Shingles Lesion Clearance and Regression of Herpes Zoster Neuralgia in Case Study Using Topical Galectin-3 Antagonism” showed a time lapsed clearance of the shingles lesions using a topical Galectin-3 antagonist.