BioSpace News Archive

The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter.

Zealand Pharma A/S announced the annual report for the year ended December 31, 2023, and provided a corporate update.

IRLAB Therapeutics AB announced that the company will present two abstracts at the scientific conference AD/PD™ 2024: 18th International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Lisbon, Portugal, on March 5-9, 2024.

PureTech Health plc, a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, noted that its Founded Entity Akili, Inc. announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare.

Vicore Pharma Holding AB, unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists, announced participation in the following investor conferences.

AlzeCure Pharma AB announced that its Year-end report for the period January - December 2023 is now available on the company’s website.

PENTAX Medical, a division of HOYA Group, have obtained CE marks for new models of PENTAX Medical i20c Video Endoscope Series - PENTAX Medical Video Colonoscope EC34-i20c, PENTAX Medical Video Upper GI Scope EG27-i20c and R/L Knob Adaptor OE-B17.

Allecra Therapeutics, a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced that the U.S. Food and Drug Administration has approved EXBLIFEP®, as a treatment for complicated urinary tract infections, including pyelonephritis, in patients 18 years and older.

Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, reported financial results for the quarter and year ended December 31, 2023, and provided a business update.