BioSpace News Archive

AI Medical Service Inc., one of the world’s first real-time endoscopic artificial intelligence (AI) developers, today announced the Company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its AI programs that analyze endoscopy images for potential diagnosis of gastric cancer.

Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for damage or transection to peripheral nerves, today announced that Karen Zaderej, chairman, CEO, and president, will present at the Jefferies London Healthcare Conference.

Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to discover breakthrough medicines for patients, today announced the company will present new preclinical data showing its first-in-class selective and potent oral IRAK4 degraders demonstrate broad and robust in vitro and in vivo inhibition of the toll-like receptor (TLR) and Interleukin-1 receptor (IL-1R) pathways underlying the pathogenesis of many inflammatory and autoimmune diseases.

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib.

MyoKardia, Inc. (Nasdaq: MYOK) today announced new data from the company’s PIONEER open-label extension (OLE) study of mavacamten for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM).

Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients and families affected by complement-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug Application (IND) for ACH-5228, the Company’s second-generation oral factor D inhibitor.

Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI; OTCQX:NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that the United States District Court for the District of New Jersey has denied a motion for summary judgment filed by Dr. Reddy’s Laboratories Inc. (DRL)

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that three preclinical posters on EDP-305, Enanta’s lead Farnesoid X receptor (FXR) agonist, will be presented today at The Liver Meeting® 2019, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 8-12, 2019 in Boston.

Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, today reported financial results for the three and nine months ended September 30, 2019 and provided a business update.

Aerami Therapeutics, a clinical-stage company reimagining the treatment of chronic diseases with inhaled therapies, today announced that it will present two posters on its Dance 501 inhaled human insulin product candidate for type 1 and type 2 diabetes, at the 19th Diabetes Technology Meeting taking place on November 14-16, 2019 in North Bethesda, Maryland.