Janet Woodcock and AstraZeneca

Selected healthcare news for the person - Janet Woodcock, and the company - AstraZeneca. We have 15 shared news items for this connection to-date.

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7/1/2021 FDA includes warning of rare heart inflammation risk on Pfizer, Moderna vaccines ... AstraZeneca, Pfizer vaccines effective against Delta variants ‚Ai STUDYIn a statement, acting FDA commissioner, Janet Woodcock, said ‚AuThe risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered.‚AuThe benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications,‚Au she said.The FDA update follows a ...
4/28/2021 Biden's economic plan leaves health policy fights behind - POLITICO Politico ... AstraZeneca vaccines abroad stunned some senior officials, who'd spent the past month sparring over when to share doses with the rest of the world.‚Ai The FDA is considering restricting the sale of three cancer therapies, in an early test for acting agency chief Janet Woodcock.WELCOME TO WEDNESDAY PULSE ‚Ai We‚Aod never ask you your favorite PULSE cat , they‚Aore all great, but if you have opinions and ...
4/21/2021 FDA Finds Poor Conditions at Contractor's Plant for Making J&J's Covid-19 Vaccine - WSJ The Wall Street Journal ... redacted, but people familiar with the matter have said they are the Covid-19 vaccines from J&J and from AstraZeneca AZN -0.85% PLC.The U.S. Food and Drug Administration, which inspected the plant owned ... meets our expectations for quality,‚Au said FDA Acting Commissioner Janet Woodcock and Peter Marks, who heads the FDA department overseeing vaccines.The Emergent plant recently had a contamination-related mishap that ruined a batch ...
4/20/2021 Inoculating the Government - WSJ The Wall Street Journal ... AstraZeneca ‚Aos vaccine, which uses similar technology.The agencies said the pause was necessary to notify health-care providers how to treat the unusual clots and give regulators time to review cases. Fair enough. FDA Acting Commissioner Janet Woodcock said the pause would only be days, and the White House assured the public it wouldn't frustrate vaccinations. That‚Aos not what happened.The CDC convened a meeting of its Advisory ...
4/14/2021 Info on the Johnson and Johnson shot ... Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots.The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca‚Aos COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.J&J ...
4/13/2021 U.S. Recommends Pausing Use of J&J COVID Vaccine over Rare Blood Clots ... Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots.The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca‚Aos COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.FDA official ...
4/13/2021 U.S. pauses J&J COVID-19 vaccine over rare blood clots Yahoo News ... Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots.The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca's COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.FDA official Peter ...
4/13/2021 U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe ... Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots.The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca‚Aos COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.FDA official ...
4/13/2021 U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe Yahoo News ... Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots.The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca's COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.FDA official Peter ...
4/13/2021 US pauses use of J&J vaccine, rollout delayed in Europe ... Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots. The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca‚Aos Covid-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths. J&J ...
3/29/2021 5 FDA approval decisions to watch in the second quarter | BioPharma Dive ... have a new full-time commissioner. But whoever fills the seat in the coming months ‚Ai be it acting chief Janet Woodcock or another candidate ‚Ai could start the job with some tough decisions to ... agency will likely soon begin reviewing a coronavirus vaccine from AstraZeneca that has been the subject of an unusual public dispute between the drugmaker and its independent trial review board.Within the next three months ...
3/17/2021 FDA's toughness towards AbbVie, FibroGen and Acadia raise worries of more stringent drug reviews: analyst FiercePharma ... Geoffrey Porges warned investors that may be the case. The FDA issued last-minute notices to FibroGen and its partner AstraZeneca on their anemia candidate roxadustat, and to Acadia for a label expansion on its ... House, ‚Auraise questions about whether the FDA under acting commissioner Janet Woodcock, who is effectively auditioning for the permanent role, is adopting a more stringent approach to drug reviews, at least for the time being ...
7/23/2020 Opinion: Using a global network of adaptive clinical trials to fight Covid-19 STAT ... already gaining traction in oncology and other areas before Covid-19 struck. They’re a subset of master protocol trials that Janet Woodcock, the Food and Drug Administration’s long-serving director for drug evaluation and research ... with outbreaks raging on three continents, research heads at Amgen, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Novartis, and Takeda began exchanging information. We were soon joined by R&D heads of other major biopharma ...
7/14/2020 Coronavirus vaccine development at ‘warp speed pace,’ officials say Washington Examiner ... even faster, and we believe we will have options for saving American lives as soon as early fall.” But Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research, admitted that though ... millions of dollars to improve manufacturing capabilities for companies including AstraZeneca, Moderna, Johnson & Johnson, and Emergent BioSolutions to be able to scale up to the millions quickly. Recently, OWS also announced a $450 million investment ...
4/28/2020 4 top drugmakers are studying the body's own efforts to fight off viruses as they race to find a COVID-19 treatment that could be ready by the fall Business Insider An antibody therapeutic could land in the sweet spot of the hunt for a coronavirus treatment. Researchers think they could be relatively effective, and they could be available this fall, far sooner than a vaccine. They are likely to work much better against the virus than drugs being tested now in patients, since they are designed to fight the novel coronavirus. There are four major ongoing research efforts for an ...