BioCentury | Dec 22, 2020
Politics, Policy & Law

Budget bill extends pediatric priority review vouchers, boosts NIH, FDA

Congress has passed an omnibus spending and pandemic relief bill that increases biomedical research funding, funds FDA’s COVID-19 response activities, extends the pediatric priority review voucher program and closes loopholes in the Orphan Drug Act. ...
BioCentury | Dec 18, 2020
Regulation

FDA panel for mRNA-1273 highlights challenges ahead for COVID vaccine trial recruitment, retention

...the division of clinical innovation at NIH’s National Center for Advancing Translational Sciences, abstained...
BioCentury | Dec 12, 2020
Regulation

As U.S. joins U.K., Canada in authorizing BNT162b2 for COVID-19, all eyes turn to deployment

...the Division of Clinical Innovation at NIH’s National Center for Advancing Translational Sciences...
BioCentury | Dec 11, 2020
Product Development

Pfizer-BioNTech COVID-19 vaccine endorsed at shambolic advisory committee meeting

...the Division of Clinical Innovation at NIH’s National Center for Advancing Translational Sciences...
BioCentury | Oct 24, 2020
Regulation

Advice now, consent later, on COVID-19 vaccines

FDA’s Oct. 22 vaccines advisory committee meeting was principally intended to reassure the public that career staff will make decisions about COVID-19 vaccines and will not be influenced by political preferences or timetables. A second...
BioCentury | Sep 22, 2020
Product Development

NIH expands plasma studies, raising questions about FDA’s emergency authorization

...are being funded by $48 million from Operation Warp Speed, are being overseen by NIH’s National Center for Advancing Translational Sciences...
BioCentury | Sep 10, 2020
Product Development

BioNTech, Pfizer complete exploratory talks with the European Commission for 200M COVID-19 vaccine doses

...0.61, 1.83).NCATS portal for sharing assays, datasetsNIH’s National Center for Advancing Translational Sciences...
...enzyme 2 Sandi Wong BNT162b2 Ampion (AP-013) BioNTech SE Pfizer Inc. University of Washington National Center for Advancing Translational Sciences Verily...
BioCentury | Jun 26, 2020
Product Development

Gilead goes for lung delivery of remdesivir, earlier COVID-19 disease stage

...more drugs that could be repurposed against COVID-19, the Critical Path Institute (C-Path) and the National Center for Advancing Translational Sciences...
...test on June 18. Sandi Wong, Assistant Editor Veklury, remdesivir (GS-5734) Gilead Sciences Inc. Critical Path Institute The Scripps Research Institute National Center for Advancing Translational Sciences Schroedinger...
BioCentury | Jun 17, 2020
Product Development

TransCelerate broadens access to shared COVID-19 trial data

...The COVID R&D consortium has also prioritized data sharing, specifically that of real-world data. The National Center for Advancing Translational Sciences...
BioCentury | Jun 15, 2020
Product Development

NCATS seeks to create hub for COVID-19 data; Regeneron reports preclinical data backing antiviral mAb cocktail

...NCATS has launched a collaborative aimed at facilitating data sharing among COVID-19 countermeasure developers. The National Center for Advancing Translational Sciences...
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1 - 10 of 115
BioCentury | Dec 22, 2020
Politics, Policy & Law

Budget bill extends pediatric priority review vouchers, boosts NIH, FDA

Congress has passed an omnibus spending and pandemic relief bill that increases biomedical research funding, funds FDA’s COVID-19 response activities, extends the pediatric priority review voucher program and closes loopholes in the Orphan Drug Act. ...
BioCentury | Dec 18, 2020
Regulation

FDA panel for mRNA-1273 highlights challenges ahead for COVID vaccine trial recruitment, retention

...the division of clinical innovation at NIH’s National Center for Advancing Translational Sciences, abstained...
BioCentury | Dec 12, 2020
Regulation

As U.S. joins U.K., Canada in authorizing BNT162b2 for COVID-19, all eyes turn to deployment

...the Division of Clinical Innovation at NIH’s National Center for Advancing Translational Sciences...
BioCentury | Dec 11, 2020
Product Development

Pfizer-BioNTech COVID-19 vaccine endorsed at shambolic advisory committee meeting

...the Division of Clinical Innovation at NIH’s National Center for Advancing Translational Sciences...
BioCentury | Oct 24, 2020
Regulation

Advice now, consent later, on COVID-19 vaccines

FDA’s Oct. 22 vaccines advisory committee meeting was principally intended to reassure the public that career staff will make decisions about COVID-19 vaccines and will not be influenced by political preferences or timetables. A second...
BioCentury | Sep 22, 2020
Product Development

NIH expands plasma studies, raising questions about FDA’s emergency authorization

...are being funded by $48 million from Operation Warp Speed, are being overseen by NIH’s National Center for Advancing Translational Sciences...
BioCentury | Sep 10, 2020
Product Development

BioNTech, Pfizer complete exploratory talks with the European Commission for 200M COVID-19 vaccine doses

...0.61, 1.83).NCATS portal for sharing assays, datasetsNIH’s National Center for Advancing Translational Sciences...
...enzyme 2 Sandi Wong BNT162b2 Ampion (AP-013) BioNTech SE Pfizer Inc. University of Washington National Center for Advancing Translational Sciences Verily...
BioCentury | Jun 26, 2020
Product Development

Gilead goes for lung delivery of remdesivir, earlier COVID-19 disease stage

...more drugs that could be repurposed against COVID-19, the Critical Path Institute (C-Path) and the National Center for Advancing Translational Sciences...
...test on June 18. Sandi Wong, Assistant Editor Veklury, remdesivir (GS-5734) Gilead Sciences Inc. Critical Path Institute The Scripps Research Institute National Center for Advancing Translational Sciences Schroedinger...
BioCentury | Jun 17, 2020
Product Development

TransCelerate broadens access to shared COVID-19 trial data

...The COVID R&D consortium has also prioritized data sharing, specifically that of real-world data. The National Center for Advancing Translational Sciences...
BioCentury | Jun 15, 2020
Product Development

NCATS seeks to create hub for COVID-19 data; Regeneron reports preclinical data backing antiviral mAb cocktail

...NCATS has launched a collaborative aimed at facilitating data sharing among COVID-19 countermeasure developers. The National Center for Advancing Translational Sciences...
Items per page:
1 - 10 of 115