TUCSON, Ariz., May 19, 2021 — Critical Path Institute today announced the appointment of Robert M. Califf, MD, MACC, head of Clinical Policy and Strategy for Google parent company Alphabet’s Verily Life Sciences and Google Health divisions, to C-Path’s Board of Directors. Califf served as the U.S. Food and Drug Administration (FDA) Commissioner under President Barack Obama’s administration from 2016-2017.Continue reading→
Category Archives: AZBio News
CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure for etranacogene dezaparvovec
• Etranacogene dezaparvovec (AMT-061) is an investigational gene therapy that may potentially provide people with hemophilia B with years of functional levels of Factor IX, a blood-clotting protein that prevents excessive bleeding.
• uniQure will complete the Phase 3 HOPE-B trial and scale up manufacture for initial commercial supply under an agreed plan with CSL Behring.
TGen-led study of more than 70,000 individuals links dementia to smoking and cardiovascular disease
Significantly, women impaired more by smoking; men impaired more by cardiovascular disease
PHOENIX, Ariz. — May 13, 2021 — In the largest study of the associations between smoking and cardiovascular disease on cognitive function, researchers at the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, found both impair the ability to learn and memorize; and that the effects of smoking are more pronounced among females, while males are more impaired by cardiovascular disease.
Arizona Expands Telehealth Law, Making it Broadest in the Nation
On May 5, 2021, Governor Ducey signed H.B. 2454, legislation which dramatically expands access to telehealth services in Arizona. The legislation—the most expansive in the country—makes telemedicine a permanent fixture of Arizona’s healthcare system.Continue reading
C-Path Announces Accelerated Data Sharing Collaboration with Tufts Medical Center
FDA Grant Supports Use of Real-World Data to Generate Real-World Evidence in Neonates
TUCSON, Ariz., May 12, 2021 — Critical Path Institute (C-Path) and Tufts Medical Center have announced a joint venture to integrate the first patient-level clinical trial data to generate actionable real-world evidence (RWE) for neonatal drug development, from real-world neonate data (RWD). This activity, funded by a grant from the U.S. Food and Drug Administration (FDA), is being executed through a neonatal pilot project within C-Path’s International Neonatal Consortium (INC). The data sharing collaboration and transfer also marks the fastest on record for C-Path — starting with the Data Contribution Agreement negotiations and receipt of the data in three months’ time this March.Continue reading
Bioscience Startup Wins University of Arizona Center for Innovation Sponsored Launch
TUCSON, Ariz. (May 11, 2021) — The University of Arizona Center for Innovation (UACI) is pleased to announce that uPetsia is the winning startup for the UACI Sponsored Launch Fueled by the Oro Valley Chamber of Commerce competition.
Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents
- In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years
- Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks
Clouds Over the Capitol
TRIPS Waiver, MCIT, HR3. If you are not familiar with these policy developments, you probably should be.
The United States medtech and biotech industries make a tremendous impact on people’s lives. When policy makers and Federal Agencies work together, the impact is made even greater. However, some policy decisions can have the opposite effect.
BIO Extends Agreement with Avantor
Collaboration has evolved for more than two decades
BD Announces Intent to Spin Off Diabetes Care Business to Enhance Focus on Innovation and Priority Growth Markets
Standalone Diabetes Care business expected to leverage position as global leader in insulin delivery and expand presence in large and high-growth diabetes marketContinue reading