BioCentury | Feb 6, 2021
Regulation

The variables shaping FDA’s guidance for new SARS-CoV-2 strains

While FDA has made it clear that efficiency is a priority in adapting authorized COVID-19 products to new viral variants, questions remain about what circumstances would require a new vaccine launch, the...
BioCentury | Jan 29, 2021
Product Development

Novavax data sets benchmark for protein vaccines, bolsters South African variant’s status as bigger risk to first-wave products

Novavax’s efficacy readout suggests protein vaccines against SARS-CoV-2 could rival leading modality mRNA, and provides more evidence that among the two most watched viral variants, the South African strain poses the bigger resistance threat for...
BioCentury | Jan 20, 2021
Politics, Policy & Law

Exit interview: Hahn departs after tumultuous tenure, advocating greater independence for FDA

FDA Commissioner Stephen Hahn presided over the most tumultuous era in FDA’s history, one that will be remembered for the agency’s failure to take aggressive actions at the start of the COVID-19 outbreak,...
BioCentury | Jan 16, 2021
Politics, Policy & Law

Woodcock’s appointment as acting FDA commissioner could be audition for permanent position

Politics, Policy & Law When Janet Woodcock moves into the FDA commissioner’s office next week, she will take charge, at least on an acting basis, of an agency that has been pummeled for months. President...
BioCentury | Jan 15, 2021
Finance

Investors’ picks & access to capital in 2021: a BioCentury podcast

Targeted cancer programs are catching the eyes of buysiders as they kick off the New Year with a positive outlook for the capital markets. On the latest BioCentury This Week podcast, BioCentury editors discuss investor...
BioCentury | Jan 14, 2021
Politics, Policy & Law

Calls to make Woodcock permanent FDA commissioner

News that President-elect Joe Biden plans to ask Janet Woodcock to run FDA on an interim basis in the weeks or months after his inauguration is being celebrated by biopharma companies and patient advocates, who...
BioCentury | Jan 12, 2021
Deals

Jan. 11 Quick Takes: Inmagene gains options to four Chi-Med immunology programs; plus Zai-Turning Point, Mirati-Resolution, GSK-Eligo, Biogen-Apple, Adaptive-AZ and more

Chi-Med, Inmagene partner on immunological indicationsHutchison China MediTech Ltd. (NASDAQ:HCM; LSE:HCM) granted Inmagene Biopharmaceuticals Co. Ltd. exclusive options to four immunological diseases programs for up to $95 million in development milestones, $135 million in commercial...
BioCentury | Jan 9, 2021
Finance

Targeted oncology is having a moment, again

The pandemic has only deepened the already heavily-weighted oncology focus of many portfolios, and it’s targeted oncology opportunities that are catching the eyes of buysiders in 2021. A combination of...
BioCentury | Jan 8, 2021
Product Development

Caplan sees a host of bioethical turning points coming out of the pandemic

The reckoning that will come after the pandemic will see broad if not tectonic shifts in drug development, from clinical trial conduct to scientific publishing, according to bioethicist Arthur Caplan....
BioCentury | Jan 8, 2021
Deals

ArsenalBio reaches next stage of maturity with BMS deal

In its first deal with a major pharma, ArsenalBio will put its synthetic biology toolkit to the test in creating programmable T cell therapies against solid tumor targets chosen by BMS. ArsenalBio as among the...
Items per page:
1 - 10 of 1611
BioCentury | Feb 6, 2021
Regulation

The variables shaping FDA’s guidance for new SARS-CoV-2 strains

While FDA has made it clear that efficiency is a priority in adapting authorized COVID-19 products to new viral variants, questions remain about what circumstances would require a new vaccine launch, the...
BioCentury | Jan 29, 2021
Product Development

Novavax data sets benchmark for protein vaccines, bolsters South African variant’s status as bigger risk to first-wave products

Novavax’s efficacy readout suggests protein vaccines against SARS-CoV-2 could rival leading modality mRNA, and provides more evidence that among the two most watched viral variants, the South African strain poses the bigger resistance threat for...
BioCentury | Jan 20, 2021
Politics, Policy & Law

Exit interview: Hahn departs after tumultuous tenure, advocating greater independence for FDA

FDA Commissioner Stephen Hahn presided over the most tumultuous era in FDA’s history, one that will be remembered for the agency’s failure to take aggressive actions at the start of the COVID-19 outbreak,...
BioCentury | Jan 16, 2021
Politics, Policy & Law

Woodcock’s appointment as acting FDA commissioner could be audition for permanent position

Politics, Policy & Law When Janet Woodcock moves into the FDA commissioner’s office next week, she will take charge, at least on an acting basis, of an agency that has been pummeled for months. President...
BioCentury | Jan 15, 2021
Finance

Investors’ picks & access to capital in 2021: a BioCentury podcast

Targeted cancer programs are catching the eyes of buysiders as they kick off the New Year with a positive outlook for the capital markets. On the latest BioCentury This Week podcast, BioCentury editors discuss investor...
BioCentury | Jan 14, 2021
Politics, Policy & Law

Calls to make Woodcock permanent FDA commissioner

News that President-elect Joe Biden plans to ask Janet Woodcock to run FDA on an interim basis in the weeks or months after his inauguration is being celebrated by biopharma companies and patient advocates, who...
BioCentury | Jan 12, 2021
Deals

Jan. 11 Quick Takes: Inmagene gains options to four Chi-Med immunology programs; plus Zai-Turning Point, Mirati-Resolution, GSK-Eligo, Biogen-Apple, Adaptive-AZ and more

Chi-Med, Inmagene partner on immunological indicationsHutchison China MediTech Ltd. (NASDAQ:HCM; LSE:HCM) granted Inmagene Biopharmaceuticals Co. Ltd. exclusive options to four immunological diseases programs for up to $95 million in development milestones, $135 million in commercial...
BioCentury | Jan 9, 2021
Finance

Targeted oncology is having a moment, again

The pandemic has only deepened the already heavily-weighted oncology focus of many portfolios, and it’s targeted oncology opportunities that are catching the eyes of buysiders in 2021. A combination of...
BioCentury | Jan 8, 2021
Product Development

Caplan sees a host of bioethical turning points coming out of the pandemic

The reckoning that will come after the pandemic will see broad if not tectonic shifts in drug development, from clinical trial conduct to scientific publishing, according to bioethicist Arthur Caplan....
BioCentury | Jan 8, 2021
Deals

ArsenalBio reaches next stage of maturity with BMS deal

In its first deal with a major pharma, ArsenalBio will put its synthetic biology toolkit to the test in creating programmable T cell therapies against solid tumor targets chosen by BMS. ArsenalBio as among the...
Items per page:
1 - 10 of 1611