For Immediate Release:
October 20, 2021
Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:Continue reading
Author Archive: AZBio
Castle Biosciences to Acquire Cernostics
Fuels mid- and long-term growth with TissueCypher® platform enabling GI franchise
Acquisition will expand Castle’s estimated U.S. TAM by approximately $1 billionContinue reading
Overcoming regulatory challenges to licensing new biotherapeutics
Mayo Clinic’s Symposium on Regenerative Medicine and Surgery will explore the challenges and opportunities of bringing next-generation biotherapeutics to patients. Julie Allickson, Ph.D., the Michael S. and Mary Sue Shannon Director of Mayo Clinic’s Center for Regenerative Medicine, will deliver a keynote presentation addressing regulatory hurdles standing between the billions of dollars invested in regenerative therapies and the people who desperately need new options for healing.
“Last year, there was an almost a $20 billion investment in regenerative biotherapeutics. There’s a significant investment, but not many products being licensed and generating commercialized solutions for patients. What are the challenges, and what are the obstacles,” asks Dr. Allickson. “It requires a partnership to move new discoveries to licensure, engaging industry and working with government agencies to facilitate production of biotherapuetics.” Dr. Allickson is also the Otto Bremer Trust Director, Biomanufacturing and Product Development, Center for Regenerative Medicine.Continue reading
Roche announces PathAI collaboration for artificial intelligence-based digital pathology applications for improved patient care
- Artificial Intelligence technology shows promise in advancing pathology imaging, which can benefit cancer patients through more precise diagnosis leading to targeted treatment.
- Collaboration with PathAI expands pathologist access to innovative AI-powered technology to support companion diagnostic and drug development programs.
- Builds on Roche’s Digital Pathology Open Environment, expanding the company’s commitment to improving patient outcomes and advancing personalised healthcare through innovation
Expanding diagnostics business: SCHOTT signs agreement to acquire Applied Microarrays Inc.
- The acquisition of the Arizona-based microarray solutions company extends SCHOTT’s manufacturing presence in the United States and strengthens its bioscience capabilities.
- Customers will benefit from enhanced development and manufacturing capabilities including high-density microarray printing.
Collaboration with AZBio and University of Arizona Law Designed to Expand Arizona’s Life Science Regulatory Talent Base
The University of Arizona James E. Rogers College of Law and AZBio have joined forces to offer a 10% tuition discount to AZBio members for all online degrees and programs offered at the college.Continue reading
Tesis Labs Raises $20 Million in Growth Equity Capital to Expand Clinical Capacity
The funding round bolsters Tesis Labs’ capacity to meet the growing customer demand and clinical research initiativesContinue reading
Francis Collins to step down as director of the National Institutes of Health
Francis S. Collins, M.D., Ph.D., today announced his decision to end his tenure as the director of the National Institutes of Health by the end of the year. Dr. Collins is the longest serving presidentially appointed NIH director, having served three U.S. presidents over more than 12 years.Continue reading
HTG Expands Therapeutics Team
Veteran Drug Developer Stephen Barat, Ph.D. Joins to Head Company’s Therapeutics DivisionContinue reading
SynCardia Systems LLC acquired by Picard Medical, Inc
Tucson, AZ – based SynCardia is the only company in the world with a US FDA-approved temporary Total Artificial Heart (TAH). It is also CE marked in Europe and approved for use in over 30 countries around the world. The SynCardia TAH has been saving and extending lives in Europe and North America, having been implanted over 2,000 times to-date and it has accumulated hundreds of years of proven patient use and safety data.Continue reading