BioSpace News Archive

Assistek , a leader in delivering eSource solutions to collect data, electronically, from patients and clinicians in clinical trials t oday announced the release of its novel web-based electronic clinical outcome assessments (eCOA) solution to support remote data collection for patients and sites during these times of challenge d

Information on the progress of our subsidiary ViralClear Pharmaceuticals and Vicromax(tm) – a broad-spectrum orally administered anti-viral candidate for COVID-19 Upon receipt of FDA approval, Phase II clinical trial is planned to be conducted at Mayo Clinic and is set to commence within the next several weeks under the leadership of Andrew D. Badley, M.D., Chair of the COVID-19 Task Force Update on the PURE EP(tm) System comme

Today, as part of Project Orbis , the U.S. Food and Drug Administration approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body,

Statement attributable to: Carmen L. Wiley , PhD President, American Association for Clinical Chemistry “The federal guidelines for the reopening of the United States released yesterday by the Tr

FDA Continues Effort to Protect Public Health from Fraudulent and Potentially Harmful Products

Approved for Patients with HER2-Positive Metastatic Breast Cancer Who Have Received One or More Prior Anti-HER2 Therapies in the Metastatic Setting- -First HER-2 Tyrosine Kinase Inhibitor in Combination to Improve Overall and Progression-Free Survival in Patients with Metastatic HER2-Positive Breast Cancer With or Without Brain Metastases- -Application Approved Four Months Prior to Action Date Under FDA’s Real-Time Oncology Review (RTOR)-

This is a trying time the world is going through together. Stress levels (mental and physical) are at a peak.

COVID-19 is and continues to be a threat to Canada’s drug supply say Canada’s pharmacists, and they are concerned about dramatic increases and volatility in the number of reported drug shortages.

Pangea Laboratory, LLC, a clinical testing facility in Orange County, announced its COVID-19 testing capacity of 1,000 samples per day. Pangea’s SARS-CoV-2 testing service is validated for both throat swabs and sputum specimens, and test results are available within 24 hours of sample arrival.

Expanded Access Program allowing additional eligible patients with COVID-19 associated cytokine storm to receive ruxolitinib is also open for enrollment in the United States