BioSpace News Archive

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy.

Calyxt, Inc. (NASDAQ:CLXT) and Cellectis S.A. (NASDAQ:CLLS – EURONEXT GROWTH: ALCLS) announced today the appointment of James A. Blome, former President and CEO of Bayer CropScience LP (North America), as Chief Executive Officer of Calyxt, effective October 1, 2018.

Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the second and third of three planned Phase 3 clinical trials for sulopenem, Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections.

The safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities.

MILabs is pleased to announce that its new VECTor6 with Broadband Photon Tomography technique has received the Commercial Innovation Award at the World Molecular Imaging Congress (WMIC) in Seattle September 12th-15th, 2018.

Leading researchers in emergency medicine will present nearly 500 studies during the Research Forum at ACEP18-Scientific Assembly, the annual meeting of the American College of Emergency Physicians (ACEP) at the San Diego Convention Center from October 1-3, 2018.

CloudLIMS is hosting a live webinar on September 25, 2018, on Biospecimen Quality for Precision Medicine.

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA).

CryoLife, Inc. announced today that it will participate in the upcoming Deutsche Bank 26th Annual Leveraged Finance Conference on Tuesday, October 2, 2018 at The Phoenician in Scottsdale, AZ.

Presentation to Highlight UNITE technology application to oncology