BioSpace News Archive

Neutra Corporation today announced the execution of a binding letter of intent to acquire Mercury Clinical Research, a privately-owned site management organization (SMO) comprised of a network of physicians conducting clinical trials for top-tier pharmaceutical companies.

Evoke Pharma, Inc. today announced that a joint stipulation of dismissal has been filed in the GIMOTI ® patent infringement case (Civil Action No. 1:22-cv-02019) in the United States District Court for the District of New Jersey.

Nanoscope Therapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of Stargardt disease to improve visual function.

NuVasive, Inc. announced today the Company will release its fourth quarter and full-year 2022 results on Wednesday, February 22, 2023 , after the close of the market.

Stemline Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Equilibre Biopharmaceuticals Corp. today reported positive topline results from the Phase 2 clinical trial evaluating the clinical safety, tolerability, and preliminary efficacy of EQU-001 – a novel anti-inflammatory anti-seizure medication - administered as once-daily oral adjunctive therapy for focal seizures in adults with epilepsy.

Guardant Health receives FDA approval for Guardant360 ® CDx as companion diagnostic for Menarini Group’s ORSERDU™ for treatment of patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer.

Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has acquired SAMDI Tech, Inc , a leading provider of high-quality, label-free high-throughput screening (HTS) solutions for drug discovery research.

Xeris Biopharma Holdings, Inc. today announced that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals, Inc., orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative.

Escient Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP262, enabling the initiation of a Phase 1 first-in-human study for the company’s second drug candidate to be advanced into clinical development.