BioSpace News Archive

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the U.S. Food and Drug Administration (FDA) accepted the Company’s resubmission of the Biologics License Application (BLA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.

RemeGen Co., Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG).

CANbridge Pharmaceuticals, Inc., a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced that it will take part in two upcoming investor conferences.

BrainChip Holdings Ltd, the world’s first commercial producer of ultra-low power neuromorphic AI IP, has extended the breadth and depth of its neuromorphic IP with two new patents granted by the US Patents and Trademarks Office, and the acquisition of previously licensed technology from Toulouse Tech Transfer.

Etiometry , a leader in clinical decision-support software for critical care, announced today that the company has obtained the CE Mark under the European Union’s medical device regulation, marking the second adult and third pediatric market authorization.

$97 million investment enhances bioanalytical services, helping pharma and biotech customers accelerate drug development Thermo Fisher Scientific, the world leader in serving science, expanded its clinical research operations with the opening of a state-of-the art bioanalytical lab in Richmond, Virginia.

T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial results for the third quarter ended September 30, 2022.

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today announced its management team will participate in an Opening Bell Ceremony at the Nasdaq Stock Market on Thursday, October 13, 2022.

Simulations Plus , Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of version 9.8.3 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling platform, GastroPlus®.

Stryker, one of the world’s leading medical technology companies, will feature its suite of procedural solutions for spinal surgery, including its award-winning Q Guidance System with Spine Guidance Software, during the North American Spine Society annual meeting in Chicago, Oct. 12–15.