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AdvaMed Calls for Renewed Effort to Sustain and Strengthen COVID Test Manufacturing
Today, AdvaMed President and CEO Scott Whitaker issued a statement following the White House’s announcement that the federal government’s COVID-19 response would be reduced in the coming weeks without additional funding from Congress.
AdvaMed Statement on White House Request for Information on COVID-19 Test Manufacturing
Today, AdvaMed President and CEO Scott Whitaker applauded the White House’s Request for Information on policies to sustain diagnostic test manufacturing for COVID-19. This comes as AdvaMedDx, a division of AdvaMed that represents more than 75 diagnostic companies, and other partners have encouraged the Biden Administration to do more to maintain COVID-19 test manufacturing capacity and implement public-private agreements to shore up supply.
BD Collaborates with U.S. Government on Development of COVID-19 Combination Diagnostic Tests
BARDA to Invest $24.7 Million for BD to Develop New Tests for Core Labs, Hospitals and Point-of-Care Locations
BD Unveils Nebraska-Based Manufacturing Capacity to Support U.S. Vaccination Agility and Preparedness
New Manufacturing Lines Will Provide U.S. Government with Priority Access to Hundreds of Millions of Needles and Syringes; Bolster Supply Readiness
COVID-19 mRNA Vaccine that Uses Fundamental Penn Technology Receives FDA Approval
The U.S. Food and Drug Administration (FDA) has given the first full approval to a COVID-19 mRNA vaccine, which uses modified mRNA technology invented and developed by scientists in the Perelman School of Medicine at the University of Pennsylvania, whose years of research in mRNA science laid a critical piece of the foundation for the largest global vaccination campaign in history. A research partnership between Drew Weissman, MD, PhD, the Roberts Family Professor in Vaccine Research, and Katalin Karikó, PhD, an adjunct professor of Neurosurgery at Penn and a senior vice president at BioNTech, dating back two decades led to the development of modified mRNA technology that has been licensed as a key foundational component of the highly effective Pfizer/BioNTech mRNA COVID-19 vaccine being deployed worldwide.
MedTech POV Podcast with Scott Whitaker | FDA’s Dr. Jeff Shuren Says Agency Should “Re-envision” Medical Device Regulatory Framework
Dr. Jeff Shuren, the head of FDA’s medical device division, told a medtech audience on a podcast released this week that the agency should “re-envision” the medical device regulatory framework. Dr. Shuren recently appeared on the newly launched MedTech POV podcast hosted by AdvaMed President and CEO Scott Whitaker.
Johnson & Johnson Statement on Supply of its Single-shot COVID-19 Vaccine
Johnson & Johnson confirms the United States Food & Drug Administration (FDA) has authorized two batches of drug substance, manufactured at the Emergent BioSolutions, Inc. Bayview facility, under the Emergency Use Authorization (EUA) for its single-shot COVID-19 vaccine.
USA Swimming Partners with BD to Provide COVID-19 Screening for the Olympic Trials and Other Competitive Swimming Events
USA Swimming and BD (Becton, Dickinson and Company), a leading global medical technology company, have partnered to provide COVID-19 testing at USA Swimming events. Specifically, rapid antigen tests using the BD Veritor™ Plus System will be conducted at the U.S. Olympic Team Trials – Swimming as an additional safety measure beyond the polymerase chain reaction (PCR) testing that will also be a part of USA Swimming’s COVID-19 mitigation efforts. These tests will also be utilized at 2021-2022 USA Swimming events where testing is required.
New collaboration tackles COVID-19 ‘infodemic’ in real time
Damage from the COVID-19 pandemic has been amplified by the accompanying “infodemic” of false and misleading online information. To date, most efforts to mitigate the spread of COVID-19 misinformation have been largely unsuccessful as they retroactively attempt to correct false narratives only after they have extensively spread online. A new collaborative effort between Battelle, the Ohio State University, and Northwestern University, sponsored by a $1 million grant from the Intelligence Advanced Research Projects Activity (IARPA), aims to address this problem by assessing the risk of COVID-19 misinformation in near real time.