Industry

Sagimet Biosciences Announces Appointment of David Happel to Chief Executive Officer; Dr. George Kemble to Transition to Executive Chairman Role

SAN MATEO, Calif.–(BUSINESS WIRE)–#Clinicaltrials–Sagimet Biosciences, a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, announced today that it has appointed David Happel as chief executive officer, replacing George Kemble, PhD, who will transition to become executive chairman of the board. “We are pleased to welcome Dave as our new chief executive officer. He … [Read more…]

Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo (TSE: 4568) received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and … [Read more…]

Ferring Presents Seven New Analyses at ACG 2022 for RBX2660, Its Investigational Microbiota-Based Live Biotherapeutic

A new 24-month subgroup analysis looked at sustained clinical response in participants who received up to two doses of RBX2660 across age, sex, race, and number of prior CDI episodes Two post hoc analyses of RBX2660 reviewed physical, mental, and social health-related quality of life (HRQL) data from PUNCH™ CD3 clinical program An oral presentation … [Read more…]

Tricida Reports Topline Results from the VALOR-CKD Phase 3 Trial of Veverimer

Webcast today at 8:00 am Eastern Time SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc. (NASDAQ: TCDA) announced today the top-line results from its VALOR-CKD renal outcomes clinical trial, designed to evaluate veverimer’s ability to slow CKD progression in patients with metabolic acidosis and chronic kidney disease (CKD). Primary Endpoint Analysis The VALOR-CKD trial did not meet … [Read more…]

Novaliq Announces FDA Acceptance of the New Drug Application for CyclASol® for the Treatment of Dry Eye Disease

PDUFA target action date is June 8, 2023 HEIDELBERG, Germany, and CAMBRIDGE, MA, USA–(BUSINESS WIRE)–#cyclasol–Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a … [Read more…]

Castle Biosciences Presents New Data Demonstrating the Impact of DecisionDx®-SCC Test Results on the Management of Medicare-Eligible Patients with Cutaneous Squamous Cell Carcinoma and One or More Risk Factors

Multiple poster presentations at the 2022 Fall Clinical Dermatology Conference share this and other data supporting Castle’s suite of tests for skin cancer FRIENDSWOOD, Texas–(BUSINESS WIRE)–$CSTL #CSTL–Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data from UTILISE (Clinical Utility and Health Outcomes Study), a … [Read more…]

Enveric Biosciences Advances Lead Candidate for the Treatment of Anxiety Disorders to IND-Enabling Studies

— Next Generation Psilocin Prodrug, EB-373, Nominated to Advances to IND-Enabling Studies — —First Generation EVM101 Program for Cancer Related Distress has been discontinued — CAMBRIDGE, Mass.–(BUSINESS WIRE)–Enveric Biosciences Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction … [Read more…]

BioTools Innovator Names GenNext Technologies The 2022 Winner

GenNext Technologies Wins the $250,000 Grand Prize at the BioTools Innovator Capstone Event LOS ANGELES–(BUSINESS WIRE)–#diagnostics—BioTools Innovator, the first-ever accelerator focused on life science tools companies, announced today that GenNext Technologies is the grand prize winner of the BioTools Innovator 2022 Final competition. The winning company was determined by a live audience vote on Thursday, … [Read more…]

G42 Healthcare Strengthens Clinical Genomics Offering with Saphetor’s VarSome Bioinformatics Platform, Strengthens UAE’s Position as a Global Leader in Healthcare Innovation

New solution to empower accurate interpretation of Next-Generation Sequencing data Expanded offerings to make personalized treatment options a reality in UAE and region ABU DHABI, United Arab Emirates–(BUSINESS WIRE)–#genomics–In a step aimed at boosting its clinical genomics capabilities in the region and beyond, G42 Healthcare, Abu Dhabi-based leading AI health-tech company, has announced a partnership … [Read more…]

Ocular Therapeutix™ To Report Third Quarter 2022 Financial Results

BEDFORD, Mass.–(BUSINESS WIRE)–$OCUL #OCUTX–Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report third quarter ended September 30, 2022 financial results after the close on Monday, November 7, 2022. Following distribution of the earnings release … [Read more…]