BioCentury | Feb 23, 2021
Product Development

FDA’s Marks says time is now to start trials for vaccines against new COVID-19 variants as agency issues guidance

FDA is outlining a streamlined clinical development path for COVID-19 vaccines against emerging variants based on clinical immunogenicity studies, and it’s time for manufacturers to start those trials,...
BioCentury | Feb 22, 2021
Management Tracks

Fresh from $21B Gilead deal, Immunomedics vet Malik to lead newly rebranded precision medicines company Fore

Israeli diagnostics company Novellus has tapped former Immunomedics executive Usama Malik as its new CEO as it moves to the U.S. and rebrands as a precision therapeutics company, the newly named Fore Biotherapeutics....
BioCentury | Feb 10, 2021
Politics, Policy & Law

Congressional Democrats urge FDA to relax restrictions on access to abortion drug

Congressional Democrats who want FDA to relax restrictions on abortion medications aren’t waiting for the confirmation of an HHS secretary or FDA commissioner to press their case. Eleven Democratic members...
BioCentury | Feb 9, 2021
Finance

Illumina unveils latest entrants to accelerator in SF, U.K.

Genomics player Illumina has added nine more start-ups to the stable of genomics newcos residing at its Illumina Accelerator. On Monday, Illumina Inc. (NASDAQ:ILMN) announced the latest round of companies selected in the accelerator’s global...
BioCentury | Jan 29, 2021
Politics, Policy & Law

What we must do to prepare for the next pandemic, a guest commentary

The U.S. is not ready for the next pandemic. Our public health infrastructure and planning process are not up to the challenge, our capacity to treat at-risk citizens is insufficient, and we are not making...
BioCentury | Jan 22, 2021
Product Development

Slaoui on Warp Speed’s successes, limitations and lessons

Having helped create the fastest vaccine development programs in history, Moncef Slaoui has stepped down as scientific adviser and co-leader of Operation Warp Speed, the U.S. government’s initiative to develop, manufacture and distribute countermeasures to COVID-19. Slaoui and...
BioCentury | Jan 20, 2021
Emerging Company Profile

Aulos: Tackling the IL-2 space with computational biology

Apple Tree Partners launched Aulos into the crowded IL-2 space last week with a $40 million series A round and a computationally designed IL-2-binding antibody it thinks could have an edge in efficacy...
BioCentury | Jan 16, 2021
Product Development

Jan. 15 Quick Takes: Darzalex gains first FDA approval for form of amyloidosis; plus Thermo Fisher, Lilly, DBV, Dr. Reddy’s, Alexion, Taiho, Astellas-Actinium

FDA granted accelerated approval to Darzalex Faspro daratumumab/hyaluronidase-fihj from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) to treat newly diagnosed light-chain amyloidosis. It is the first and only therapy for the indication, according to Genmab,...
BioCentury | Jan 15, 2021
Product Development

Delfi and Earli series A rounds show there’s room for new entrants in early cancer detection

The debut of two more venture-backed companies developing early cancer detection tests suggests there is still appetite for new approaches, even as bigger players consolidate via M&A and prepare for commercial launch. Delfi Diagnostics Inc....
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...
Items per page:
1 - 10 of 1725
BioCentury | Feb 23, 2021
Product Development

FDA’s Marks says time is now to start trials for vaccines against new COVID-19 variants as agency issues guidance

FDA is outlining a streamlined clinical development path for COVID-19 vaccines against emerging variants based on clinical immunogenicity studies, and it’s time for manufacturers to start those trials,...
BioCentury | Feb 22, 2021
Management Tracks

Fresh from $21B Gilead deal, Immunomedics vet Malik to lead newly rebranded precision medicines company Fore

Israeli diagnostics company Novellus has tapped former Immunomedics executive Usama Malik as its new CEO as it moves to the U.S. and rebrands as a precision therapeutics company, the newly named Fore Biotherapeutics....
BioCentury | Feb 10, 2021
Politics, Policy & Law

Congressional Democrats urge FDA to relax restrictions on access to abortion drug

Congressional Democrats who want FDA to relax restrictions on abortion medications aren’t waiting for the confirmation of an HHS secretary or FDA commissioner to press their case. Eleven Democratic members...
BioCentury | Feb 9, 2021
Finance

Illumina unveils latest entrants to accelerator in SF, U.K.

Genomics player Illumina has added nine more start-ups to the stable of genomics newcos residing at its Illumina Accelerator. On Monday, Illumina Inc. (NASDAQ:ILMN) announced the latest round of companies selected in the accelerator’s global...
BioCentury | Jan 29, 2021
Politics, Policy & Law

What we must do to prepare for the next pandemic, a guest commentary

The U.S. is not ready for the next pandemic. Our public health infrastructure and planning process are not up to the challenge, our capacity to treat at-risk citizens is insufficient, and we are not making...
BioCentury | Jan 22, 2021
Product Development

Slaoui on Warp Speed’s successes, limitations and lessons

Having helped create the fastest vaccine development programs in history, Moncef Slaoui has stepped down as scientific adviser and co-leader of Operation Warp Speed, the U.S. government’s initiative to develop, manufacture and distribute countermeasures to COVID-19. Slaoui and...
BioCentury | Jan 20, 2021
Emerging Company Profile

Aulos: Tackling the IL-2 space with computational biology

Apple Tree Partners launched Aulos into the crowded IL-2 space last week with a $40 million series A round and a computationally designed IL-2-binding antibody it thinks could have an edge in efficacy...
BioCentury | Jan 16, 2021
Product Development

Jan. 15 Quick Takes: Darzalex gains first FDA approval for form of amyloidosis; plus Thermo Fisher, Lilly, DBV, Dr. Reddy’s, Alexion, Taiho, Astellas-Actinium

FDA granted accelerated approval to Darzalex Faspro daratumumab/hyaluronidase-fihj from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) to treat newly diagnosed light-chain amyloidosis. It is the first and only therapy for the indication, according to Genmab,...
BioCentury | Jan 15, 2021
Product Development

Delfi and Earli series A rounds show there’s room for new entrants in early cancer detection

The debut of two more venture-backed companies developing early cancer detection tests suggests there is still appetite for new approaches, even as bigger players consolidate via M&A and prepare for commercial launch. Delfi Diagnostics Inc....
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...
Items per page:
1 - 10 of 1725