BioSpace News Archive

Orthofix Medical Inc., a leading global spine and orthopedics company, announced that Catherine Burzik has been re-appointed as the Chair of the Company’s Board of Directors.

LumiraDx Limited (Nasdaq: LMDX) today announced that it has received validation for use by the MHRA under the CTDA process for the LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV2 Ag & RSV tests.

Biocept, Inc. (Nasdaq: BIOC) (“Biocept” or the “Company”), a leading provider of molecular diagnostic assays, products and services, has named Antonino Morales as President and Chief Executive Officer, effective immediately.

BioCardia®, Inc. [Nasdaq: BCDA] today announced that FDA Center for Biologics Evaluation and Research (CBER) has completed review of the CardiAMP Cell Therapy System adaptive statistical analysis design supplement for the ongoing pivotal study to treat ischemic heart failure with reduced ejection fraction (HFrEF).

Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes.

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and the University of Oxford today announced that results from the SYMPLIFY study have been published in The Lancet Oncology.

Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”) announced today that its partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) made presentations on data from the NeflgArd Phase 3 Study at the European Renal Association – European Dialysis and Transplant Association Congress (ERA-EDTA), which was held in Milan, Italy, June 15-18.

Jadeite Medicines Inc., a clinical stage biopharmaceutical company headquartered in Tokyo, Japan has received Orphan Drug Designation for odevixibat for the expected indication of PFIC from the Ministry of Health, Labour and Welfare of Japan.