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.
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.
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.
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.
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.
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.
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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.
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