BioCentury | Dec 15, 2020
Regulation

Test of strength: Boehringer says FDA policy tilts playing field against biosimilars

Among the many properties of Humira, one of the most surprising is its use as a probe to uncover a seemingly endless series of legal and regulatory maneuvers that allow its manufacturer, AbbVie, to maintain...
BioCentury | Oct 30, 2020
Distillery Therapeutics

KSP as a neuroblastoma target

DISEASE CATEGORY: Cancer INDICATION: Neuroendocrine tumors Inhibiting the mitotic kinesin KSP could treat neuroblastoma, a pediatric sympathetic nervous system malignancy. In neuroblastoma patients, high KSP expression in tumors was associated with high-risk neuroblastoma, advanced tumor...
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 | Oct 21, 2020
Regulation

Ethics arising from EUAs could disrupt COVID-19 vaccine trials

FDA and its vaccines advisory committee are facing ethical and practical conundrums that, unless they are resolved quickly, threaten to undermine the development of COVID-19 vaccines. The most pressing challenge centers on whether it is...
BioCentury | Oct 17, 2020
Politics, Policy & Law

Getting FDA back on track

Regardless of the outcome of the elections, FDA is likely to have a new commissioner next year, one who will step into a leadership vacuum that is exhausting the agency’s supply of credibility and...
BioCentury | Sep 18, 2020
Product Development

Harmonizing limits of detection for FDA-authorized COVID-19 diagnostics

...in September.FDA’s analysis revealed a test from PerkinElmer Inc....
...standing. Like the majority of COVID-19 diagnostics, PerkinElmer...
...involving different PCR primers. Karen Tkach Tuzman Abbott Laboratories Quidel Corp. PerkinElmer Inc. U.S...
BioCentury | Jun 20, 2020
Product Development

China offers forward-thinking biotechs much more than an opportunity to get delayed clinical trials back on track

Weiji (危机), the Chinese term for crisis, combines the characters for “danger” and “opportunity,” an apt description of the challenge posed by COVID-19. While most of the world struggles with pandemic containment and ‘re-opening,’ China,...
BioCentury | Apr 23, 2020
Finance

Venrock closes new evergreen fund at $447M

With its new $446.8 million evergreen fund, Venrock has become at least the sixth life sciences VC to close a new fund in April. Venrock Healthcare Capital Partners (VHCP) EG was oversubscribed and raised solely...
BioCentury | Mar 25, 2020
Product Development

Bruker-Novacyt, PerkinElmer launch COVID-19 diagnostics; plus Nuclein speeds development its PCR test

...test, which has a CE-IVD mark. Stateside, FDA granted an emergency use authorization (EUA) to PerkinElmer Inc....
...2020. Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus . Sandi Wong, Assistant Editor PerkinElmer Inc. COVID-19 Nuclein...
BioCentury | Mar 24, 2020
Regulation

FDA facilitating compassionate use of convalescent plasma for COVID-19

FDA Tuesday released guidance to help physicians provide convalescent plasma to COVID-19 patients on a compassionate use basis, outside of a clinical trial. The presidents of the U.S. National Academy of Sciences, National Academy of...
Items per page:
1 - 10 of 733
BioCentury | Dec 15, 2020
Regulation

Test of strength: Boehringer says FDA policy tilts playing field against biosimilars

Among the many properties of Humira, one of the most surprising is its use as a probe to uncover a seemingly endless series of legal and regulatory maneuvers that allow its manufacturer, AbbVie, to maintain...
BioCentury | Oct 30, 2020
Distillery Therapeutics

KSP as a neuroblastoma target

DISEASE CATEGORY: Cancer INDICATION: Neuroendocrine tumors Inhibiting the mitotic kinesin KSP could treat neuroblastoma, a pediatric sympathetic nervous system malignancy. In neuroblastoma patients, high KSP expression in tumors was associated with high-risk neuroblastoma, advanced tumor...
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 | Oct 21, 2020
Regulation

Ethics arising from EUAs could disrupt COVID-19 vaccine trials

FDA and its vaccines advisory committee are facing ethical and practical conundrums that, unless they are resolved quickly, threaten to undermine the development of COVID-19 vaccines. The most pressing challenge centers on whether it is...
BioCentury | Oct 17, 2020
Politics, Policy & Law

Getting FDA back on track

Regardless of the outcome of the elections, FDA is likely to have a new commissioner next year, one who will step into a leadership vacuum that is exhausting the agency’s supply of credibility and...
BioCentury | Sep 18, 2020
Product Development

Harmonizing limits of detection for FDA-authorized COVID-19 diagnostics

...in September.FDA’s analysis revealed a test from PerkinElmer Inc....
...standing. Like the majority of COVID-19 diagnostics, PerkinElmer...
...involving different PCR primers. Karen Tkach Tuzman Abbott Laboratories Quidel Corp. PerkinElmer Inc. U.S...
BioCentury | Jun 20, 2020
Product Development

China offers forward-thinking biotechs much more than an opportunity to get delayed clinical trials back on track

Weiji (危机), the Chinese term for crisis, combines the characters for “danger” and “opportunity,” an apt description of the challenge posed by COVID-19. While most of the world struggles with pandemic containment and ‘re-opening,’ China,...
BioCentury | Apr 23, 2020
Finance

Venrock closes new evergreen fund at $447M

With its new $446.8 million evergreen fund, Venrock has become at least the sixth life sciences VC to close a new fund in April. Venrock Healthcare Capital Partners (VHCP) EG was oversubscribed and raised solely...
BioCentury | Mar 25, 2020
Product Development

Bruker-Novacyt, PerkinElmer launch COVID-19 diagnostics; plus Nuclein speeds development its PCR test

...test, which has a CE-IVD mark. Stateside, FDA granted an emergency use authorization (EUA) to PerkinElmer Inc....
...2020. Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus . Sandi Wong, Assistant Editor PerkinElmer Inc. COVID-19 Nuclein...
BioCentury | Mar 24, 2020
Regulation

FDA facilitating compassionate use of convalescent plasma for COVID-19

FDA Tuesday released guidance to help physicians provide convalescent plasma to COVID-19 patients on a compassionate use basis, outside of a clinical trial. The presidents of the U.S. National Academy of Sciences, National Academy of...
Items per page:
1 - 10 of 733