BioCentury | Feb 20, 2021
Product Development

More evidence it’s okay to delay second dose of COVID vaccines

New findings reported for COVID vaccines from partners Pfizer and BioNTech and AstraZeneca could better inform public health decisions on vaccine schedules by supporting the spacing out of first and second doses. One study, reported Friday by Chaim Sheba...
BioCentury | Feb 16, 2021
Regulation

Emerging immunotherapies need harmonization on definitions and monitoring

Turning CAR T cell therapies and T cell engaging bispecific antibodies into cornerstones of cancer immunotherapy will require standardizing the definitions and monitoring systems for the novel toxicities they bring, according to panelists at a...
BioCentury | Feb 9, 2021
Product Development

South African AZ vaccine halt marks start of variant-guided policies

Facing a challenging viral variant gone dominant, South Africa is pioneering a phased approach to COVID-19 vaccine distribution focused on preventing hospitalizations caused by the new strain.  South Africa’s new strategy was announced at a...
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 30, 2021
Politics, Policy & Law

Largely aspirational, Biden’s COVID-19 strategy hints at chance for long-term impact on drug development

The Biden administration’s strategy for COVID-19 and long-term pandemic preparedness is in large part a plan for a plan, but it contains kernels of concepts that if fully developed could transform how...
BioCentury | Jan 30, 2021
Product Development

How NCI is becoming COVID-19 serology’s unlikely hero

Charged with evaluating COVID-19 antibody responses and serological tests, NCI has bolstered the case for the protective role of antibodies using real-world data, and developed a standard that can be used to harmonize results across...
BioCentury | Jan 26, 2021
Politics, Policy & Law

Warp Speed reflections, master protocols & Biden’s COVID plan: a BioCentury podcast

On the latest edition of the BioCentury this Week podcast, BioCentury editors discuss the successes and limitations of Operation Warp Speed, proposals for streamlining master protocol trials and highlights for industry from the Biden administration’s COVID-19...
BioCentury | Dec 31, 2020
Politics, Policy & Law

Innovations forged in the COVID crucible will reshape medicine

The fight against COVID-19 is far from finished, but victory is close enough to start considering how the tools created to tame SARS-CoV2 will reshape the post-war world. As with World War II and the...
BioCentury | Dec 19, 2020
Regulation

EUA for second COVID-19 mRNA vaccine underscores the modality’s rapid response potential

FDA’s emergency use authorization for Moderna’s COVID-19 vaccine underscores the promise of mRNA to respond rapidly to viral outbreaks.  Moderna Inc. (NASDAQ:MRNA) plans to deliver about 20 million doses of mRNA-1273 by year-end, followed by 80...
BioCentury | Dec 18, 2020
Regulation

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

The discussion at Thursday’s FDA advisory committee meeting on a COVID-19 vaccine from Moderna and NIH highlighted the increasing difficulties of conducting trials as more vaccines become authorized and...
Items per page:
1 - 10 of 459
BioCentury | Feb 20, 2021
Product Development

More evidence it’s okay to delay second dose of COVID vaccines

New findings reported for COVID vaccines from partners Pfizer and BioNTech and AstraZeneca could better inform public health decisions on vaccine schedules by supporting the spacing out of first and second doses. One study, reported Friday by Chaim Sheba...
BioCentury | Feb 16, 2021
Regulation

Emerging immunotherapies need harmonization on definitions and monitoring

Turning CAR T cell therapies and T cell engaging bispecific antibodies into cornerstones of cancer immunotherapy will require standardizing the definitions and monitoring systems for the novel toxicities they bring, according to panelists at a...
BioCentury | Feb 9, 2021
Product Development

South African AZ vaccine halt marks start of variant-guided policies

Facing a challenging viral variant gone dominant, South Africa is pioneering a phased approach to COVID-19 vaccine distribution focused on preventing hospitalizations caused by the new strain.  South Africa’s new strategy was announced at a...
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 30, 2021
Politics, Policy & Law

Largely aspirational, Biden’s COVID-19 strategy hints at chance for long-term impact on drug development

The Biden administration’s strategy for COVID-19 and long-term pandemic preparedness is in large part a plan for a plan, but it contains kernels of concepts that if fully developed could transform how...
BioCentury | Jan 30, 2021
Product Development

How NCI is becoming COVID-19 serology’s unlikely hero

Charged with evaluating COVID-19 antibody responses and serological tests, NCI has bolstered the case for the protective role of antibodies using real-world data, and developed a standard that can be used to harmonize results across...
BioCentury | Jan 26, 2021
Politics, Policy & Law

Warp Speed reflections, master protocols & Biden’s COVID plan: a BioCentury podcast

On the latest edition of the BioCentury this Week podcast, BioCentury editors discuss the successes and limitations of Operation Warp Speed, proposals for streamlining master protocol trials and highlights for industry from the Biden administration’s COVID-19...
BioCentury | Dec 31, 2020
Politics, Policy & Law

Innovations forged in the COVID crucible will reshape medicine

The fight against COVID-19 is far from finished, but victory is close enough to start considering how the tools created to tame SARS-CoV2 will reshape the post-war world. As with World War II and the...
BioCentury | Dec 19, 2020
Regulation

EUA for second COVID-19 mRNA vaccine underscores the modality’s rapid response potential

FDA’s emergency use authorization for Moderna’s COVID-19 vaccine underscores the promise of mRNA to respond rapidly to viral outbreaks.  Moderna Inc. (NASDAQ:MRNA) plans to deliver about 20 million doses of mRNA-1273 by year-end, followed by 80...
BioCentury | Dec 18, 2020
Regulation

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

The discussion at Thursday’s FDA advisory committee meeting on a COVID-19 vaccine from Moderna and NIH highlighted the increasing difficulties of conducting trials as more vaccines become authorized and...
Items per page:
1 - 10 of 459