FDA Press Release: October 29, 2021 – Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.Continue reading
Author Archive: AZBio
UArizona Health Sciences Researchers Weaponizing Copper as Potential Antibiotic
Researchers identified a compound that acts as a Trojan horse for copper, effectively killing pathogens that cause some upper respiratory infections.Continue reading
leanRAQA releases new Business Market Assessment Tool for Life Science Innovators
The Business Market Assessment tool to helps you understand the initial investment and recurring regulatory compliance costs you’ll face. The guide walks you through the revenue vs cost modeling calculations to help you judge the market viability of your product and see if a specific market makes sense.
Arizona’s Launch of the NAM Pharma Manufacturing Report
Learn about the biopharmaceutical industry’s footprint in the state of Arizona as we discuss the National Association of Manufacturers’ report:
Ensuring a Health Future: The Impact and Importance of Pharmaceutical Manufacturing.
Speakers:
Shawn DuBravac, PhD, CFA, President, Aviro Institute and New York Times Best Selling Author
Garrick Taylor, EVP, Arizona Chamber of Commerce & Industry
Moderator: Joan Koerber-Walker, president & CEO, Arizona Bioindustry Association (AZBio)
Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
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
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