BioSpace News Archive

The U.S. Food and Drug Administration is issuing a Safety Communication to inform patients and health care providers that devices claiming to clean, disinfect or sanitize continuous positive airway pressure devices or accessories using ozone gas or ultraviolet light are not legally marketed for this use by the FDA in the U.S., and as such, their safety and effectiveness for use with CPAP devices and accessories is unknown.

Medidata, a Dassault Systèmes company, and the global leader in creating end-to-end solutions supporting the entire clinical trial process, announced the launch of a research partnership between the Medidata Institute and Project ALS.

President & CEO Nick Westfall of VITAS® Healthcare, the nation’s leading provider of end-of-life care, has been named one of seven new members of the board of directors of the National Hospice and Palliative Care Organization, effective January 22, 2020.

TRACON Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and utilizing a product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced financial results for the fourth quarter and year ended December 31, 2019.

Nephros, Inc. (Nasdaq:NEPH), a commercial stage company that develops and sells high performance water purification products and pathogen detection systems to the medical and commercial markets, today announced financial results for the fourth quarter and full year ended December 31, 2019.

Collegium Pharmaceutical, Inc. reported its financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update.

Coherus BioSciences, Inc., reviewed corporate events and reported financial results for the quarter and full year ended December 31, 2019.

Codexis, Inc., a leading protein engineering company, announces financial results for the three and 12 months ended December 31, 2019, provides a business update and introduces 2020 financial guidance.

GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA).

- Datavant has hired Aden Fine as General Counsel and Chief Privacy Officer - Datavant has hired Dongting Yu, PhD, as Head of Security Engineering - David Shulkin (former Secretary of Veterans Affairs) and Andrew von Eschenbach (former FDA Commissioner and NCI Director) appointed to Datavant Advisory Board