• 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.
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.
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
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
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.
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.
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
In the pandemic’s 17th month, we live in a world of vivid contrast between early-vaccinating countries that appear to be approaching an end to their epidemic and those falling rapidly into the abyss. Brazil and India are suffering escalating COVID caseloads exhausting health care resources. The long haul with the virus in the US and the current situation in Brazil and India have clearly underscored the importance of a strong, coordinated, and sustained public health response.