February 25, 2021
Aon Life Sciences Advisor
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Top Stories
The Biden administration plans to ship 3 million to 4 million doses of Johnson & Johnson's single-dose COVID-19 vaccine to states, community health centers and pharmacies as early as next week once the vaccine receives authorization from the FDA, according to Jeff Zients, the White House's COVID-19 response coordinator. An FDA analysis released Wednesday indicates the vaccine is safe, effective and meets requirements for an emergency use authorization, and the agency's Vaccines and Related Biological Products Advisory Committee is set to meet Friday to consider whether to recommend authorization.
Full Story: Reuters (2/24),  The Hill (2/24),  CNN (2/24) 
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Liability and Safety
A second Class I recall has been issued by the FDA for Boston Scientific's Emblem implantable cardioverter defibrillator due to a manufacturing error that could prevent or delay the device from giving a person in cardiac arrest an electrical shock.
Full Story: Medical Design & Outsourcing (2/22) 
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A worldwide voluntary recall was issued by Medtronic for all unused Medtronic Valiant Navion thoracic stent graft systems to investigate possible safety concerns as three people treated with the device experienced stent fractures during a global clinical trial, with one patient death reported.
Full Story: FDAnews (2/18) 
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Business and Market Trends
The price of Pfizer's COVID-19 vaccine likely will increase after the pandemic ends to bring it more in line with prices for other vaccines, said Frank D'Amelio, Pfizer's chief financial officer. The company also plans to ramp up production, D'Amelio said.
Full Story: FiercePharma (2/23) 
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Government and Regulatory
Health Care and Policy
The US FDA updated guidance on its website for drugmakers that aim to adapt their COVID-19 products, such as vaccines, diagnostics and therapeutics, to emerging coronavirus variants. The agency will not require extensive clinical testing of modified products, but it will require data demonstrating safety and efficacy similar to reference products.
Full Story: CNBC (2/22),  CNN (2/22) 
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Company and Financial News
Icon announced it will buy PRA Health for $12 billion in cash and stocks. "The combined company will create a new paradigm for accelerating clinical research and bringing new medicines and devices to market," said Icon CEO Steve Cutler.
Full Story: FierceBiotech (2/24) 
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News from Aon
The evolution of technology in the transportation industry: Thought leadership from across the spectrum
Advances in technology have made the world more efficient and much smaller. This webinar explores how the evolution of technology has benefited the transportation industry.
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Leveraging an intelligent data-driven approach to incident response and threat hunting
In this webinar, Aon's Cyber Solutions colleagues are joined by Forrester analyst Brian Kime to discuss the intersection of threat intelligence, incident response and threat hunting through use of dark web analysis and threat actor research to identify vulnerabilities, detect threats faster and respond quickly.
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Today is only one day in all the days that will ever be. But what will happen in all the other days that ever come can depend on what you do today.
Ernest Hemingway,
writer, journalist, Nobel Prize winner
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About Aon Life Sciences Practice
Aon provides Life Sciences companies with end-to-end risk solutions, supporting organizations from the initial discovery phase to final product launch. The practice provides solutions across the Life Sciences for pharmaceutical manufacturers; generic and OTC pharmaceutical companies; biotechnology and biopharmaceutical companies; genomic and proteomic companies; drug delivery system; diagnostic substance companies; and medical device and equipment manufacturers.

Contact Aon
Aon Risk Solutions – Life Sciences
James Walters, Global Practice Leader
+1.215.255.1795
james.walters@aon.com
www.aon.com

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About Aon
Aon plc (NYSE:AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance.
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