Janet Woodcock and Biotech

Selected healthcare news for the person - Janet Woodcock, and the healthcare topic - Biotech We have 21 shared news items for this connection to-date.

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3/29/2021 5 FDA approval decisions to watch in the second quarter | BioPharma Dive ... Janet Woodcock or another candidate ‚Ai could start the job with some tough decisions to make.At the top of the list is whether the agency should clear an experimental Alzheimer's drug from Biogen. That decision is among the most consequential the FDA has ever faced, as an approval or rejection will have ripple effects on Alzheimer's research, the agency's reputation and the biotech sector for years to come.But ...
3/1/2021 Woodcock's cancer crusade inspires supporters, raises concerns for others STAT Politics Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors By Nicholas Florko March 1, 2021ReprintsJanet Woodcock Tom Williams/CQ Roll Call/APW ... it? STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs ...
2/28/2021 Johnson & Johnson COVID-19 vaccine 3rd to receive emergency use authorization ... Janet Woodcock . ‚AuThe FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency‚Aos rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.‚AuThe FDA said tests on the Janssen Biotech Inc., vaccine was about 67% effective in preventing moderate to severe cases within 14 days after dosing ...
2/27/2021 Johnson (and) Johnson vaccine on track for US emergency approval (Ld) ... Biotech Inc.Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday.The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.Once FDA clears the J (and) J shot for US use, only a ...
2/27/2021 Johnson & Johnson vaccine on track for US emergency approval (Ld) ... Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout. Once FDA clears the J&J shot for US use ...
2/27/2021 Johnson & Johnson Vaccine On Track For US Emergency Approval ... Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.Once FDA clears the J&J shot for US use ...
2/27/2021 Johnson & Johnson vaccine on track for US emergency approval ... Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout. Once FDA clears the J&J shot for US use ...
2/27/2021 US expert's panel recommends authorizing single shot of Johnson & Johnson covid vaccine ... Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.Once FDA clears the J&J shot for US use ...
2/27/2021 Johnson & Johnson vaccine on track for US emergency approval ... Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.Once FDA clears the J&J shot for US use ...
2/27/2021 FDA to approve J&J vaccine soon ... Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.Once FDA clears the J&J shot for US use ...
2/27/2021 US expert's panel recommends authorizing single shot of Johnson & Johnson covid vaccine | News24 ... Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.Once FDA clears the J&J shot for US use ...
2/27/2021 FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting ... Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and ResearchSILVER SPRING, Md. , Feb. 26, 2021 /PRNewswire/ -- Following today's positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our ...
2/5/2021 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate ... Biotech Inc.‚Au A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.‚Aos COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,‚Au said Acting FDA Commissioner Janet Woodcock , M.D. ‚AuThe ...
2/4/2021 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate | FDA ... Biotech Inc. ‚AuA public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.‚Aos COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,‚Au said Acting FDA Commissioner Janet Woodcock, M.D. ‚AuThe FDA ...
7/17/2020 COVID-19 antibody drugs will be a $9 billion market in 2021, analysts say. Here are the 9 leading research programs, with some aiming to be ready this fall to halt the pandemic. Business Insider ... against the virus than drugs being tested now in patients, since they are designed to fight the novel coronavirus. AllianceBernstein biotech analyst Ronny Gal estimated COVID-19 antibody drugs will be a $9 billion market ... stages of the disease, particularly the earlier stages," said Dr. Janet Woodcock, a longtime US Food and Drug Administration director now leading the US government's coronavirus drug research strategy. There are about 50 ...
6/21/2020 The FBI called a powerful opioid developed for the military a public threat. The company selling the drug says it'll save lives. Yahoo News ... refused, he later recalled. A few weeks later he was working from his home office in Lexington, Ky., when Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, called ... meant leaving a tenured university position, but Silicon Valley’s booming biotech sector beckoned. In 2009, Palmer’s quest for a better postoperative opioid crossed paths with Buckenmaier’s interest in acute pain at a conference of the ...
6/15/2020 10 exec moves affecting the pharma industry Becker's Hospital Review ... Janet Woodcock, MD, and Peter Marks, MD, PhD, recused themselves from the agency's considerations about approving COVID-19 vaccines. The American Pharmacists Association swore in Scott Knoer, PharmD, as its 13th CEO during a virtual ceremony June 1. David Loew, executive vice president of Sanofi's vaccines unit, is leaving July 1 to become the CEO of a French biotech; Thomas Triomphe will assume his role. Alan Main, executive vice president ...
3/13/2020 FiercePharmaAsia—Legend’s U.S. IPO; U.S. reliance on China drugs; Harbour-Mount Sinai team-up FiercePharma China's Genscript Biotech is planning to spin off its cell therapy unit and Johnson & Johnson CAR-T partner Legend Biotech for a U.S. IPO. The FDA is not sure exactly to what extent the U.S ... the coronavirus outbreak. But how dependent is it? According to Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research, the agency doesn’t know how much API Chinese facilities are producing for ...
10/28/2019 STAT Plus: FDA considers a rating system for manufacturing facilities as a way to fight drug shortages STAT Janet Woodcock, head of the FDA Center for Drug Evaluation and Research. Tyrone Eaton S eeking to reduce a rising tide of shortages, the Food and Drug Administration is considering the idea of creating a ... STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs ...
9/19/2019 Innovative Data and Analytics Platform to Accelerate Drug Development for Rare Diseases PR Newswire ... make development of those treatments as efficient, effective and fast as possible," said Center for Drug Evaluation and Research Director Janet Woodcock , MD. "The way to do that is to have all the data we've ... academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland , with additional staff in multiple ...