BioSpace News Archive

One of the touchstones of medical device safety lies in the authority of the U.S. Food and Drug Administration to order manufacturers to conduct postmarket surveillance studies to address a new and significant health concern.

Immunic, Inc. (Nasdaq: IMUX), today announced the completion of its stock-for-stock exchange transaction with Vital Therapies, Inc. (Nasdaq: VTL, through April 12, 2019).

The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

Multiple new genes involved in hearing loss have been revealed in a large study of mouse mutants by researchers from the Wellcome Sanger Institute and King’s College London, and colleagues.

Great Place to Work and FORTUNE have honored Martin’s Point Health Care as one of the 2019 Best Workplaces in Health Care and Biopharma.

As part of the agency’s ongoing efforts to minimize impacts of medical product shortages, last month, the FDA alerted the public of the potential for medical device shortages to arise from the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, and the future planned closure of a similar facility in Michigan.

Aesculap, Inc., an industry leader in neurosurgical and power system solutions, is pleased to announce its participation at the 2019 annual scientific meeting of the American Association of Neurological Surgeons (AANS.)

Sameer Bhargava, Chief Information Officer and Chief Technology Officer at Caregiver, Inc., is leading the company’s technological transformation to support Caregiver’s core mission of caring for those who qualify as developmentally or intellectually disabled (IDD) or are impacted by related conditions in Texas, Indiana, Ohio and Tennessee service areas.

Further to Health Canada’s advisory on January 28, 2019, warning Canadians that all products sold by A1 Herbal Ayurvedic Clinic were unauthorized and should not be used, Health Canada is updating Canadians that it has identified additional health risks in products manufactured and sold by A1 Herbal.

With the passing of Senate Bill 220 during the Ohio 132nd General Assembly and the signature of Governor Kasich into law, Ohio is positioned as a national policy leader on the use of Blockchain technology