BioSpace News Archive

Ikerian AG (“Ikerian”) a leader in developing software solutions for medical image and data management and artificial intelligence (AI) in healthcare, today announced the registration as Class IIa medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) of 4 devices.

Trinity Biotech plc a commercial stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, announced steps to advance its next generation continuous glucose monitoring solution towards market launch.

eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR) today announced that the Company has terminated its employees and will wind down it operations, including seeking potential strategic alternatives for the Company’s development programs.

Axogen, Inc. announces the launch of its newest product, Avive+ Soft Tissue Matrix™. Avive+™ is intended for use as a soft tissue barrier and is a resorbable, multi-layer amniotic membrane allograft that provides temporary protection and tissue separation during the critical phase of peripheral nerve healing.

Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.

Oncolytics Biotech ® Inc. today announced that Matt Coffey, PhD, President and Chief Executive Officer of Oncolytics will take a medical leave of absence, effective immediately. Wayne Pisano, Chair of Oncolytics’ Board of Directors, will serve as the interim CEO during Dr. Coffey’s absence.

Adicet Bio, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to evaluate ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric antigen receptor (CAR) T cell therapy candidate targeting CD70+ cancers, for the treatment of relapsed/refractory renal cell carcinoma (RCC).

Castle’s TissueCypher test has been shown to improve the risk stratification of patients with Barrett’s esophagus (BE) 1,2.

Orthofix Medical Inc . (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the appointment of Michael Finegan as Chair of the Board of Directors.

Eyam is pleased to announce the appointment of Nicholas Franco to its Board of Advisors.