BioCentury | Feb 27, 2021
Product Development

Feb. 26 COVID Quick Takes: FDA wants more data from Merck; plus ‘clear efficacy’ for Regeneron and updates from GSK, Lilly, Novavax

Merck & Co. Inc. (NYSE:MRK) no longer expects to supply the U.S. with COVID-19 therapy MK-7110 by June 30 after FDA told the company additional data would be needed to support emergency use authorization. MK-7110,...
BioCentury | Feb 27, 2021
Distillery Therapeutics

Trastuzumab-RNA polymerase inhibitor conjugate for breast cancer with low HER2 expression

DISEASE CATEGORY: Cancer INDICATION: Breast cancer An antibody-drug conjugate comprising anti-HER2 antibody trastuzumab linked to POLR2A inhibitor α-amanitin could treat breast cancer with low HER2 expression and heterozygous loss of chromosome 17p. In a panel...
BioCentury | Feb 26, 2021
Product Development

Zaks’ impending departure but the latest milestone as Moderna charts year ahead

As Moderna prioritizes maximizing the reach of its COVID-19 vaccine, Thursday’s announcement of the impending departure of longtime CMO Tal Zaks caps a transformational 14 months for the mRNA company and comes during a year when...
BioCentury | Feb 26, 2021
Product Development

Actions COVID vaccine makers are taking to tackle variants: Data Byte

COVID-19 vaccine developers are taking multiple approaches to combat emerging SARS-CoV-2 variants, ranging from administering additional booster shots of authorized vaccines to developing variant-specific...
BioCentury | Feb 23, 2021
Product Development

Trials testing COVID-19 vaccines in kids: Data Byte

At least seven COVID-19 vaccines are or will soon be tested in pediatric volunteers, according to BioCentury’s COVID-19 Clinical Trials Dashboard. Two of the trials have already produced readouts that included pediatric subjects, but the pediatric cohort...
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 19, 2021
Translation in Brief

mAb reduces amyloid plaques without hemorrhage; plus Dyno and Ally’s AAV technologies and more

Alzheimer’s disease immunotherapy reduces β-amyloid without increasing brain bleedingPublished in Science Translational Medicine, Denali Therapeutics Inc. (NASDAQ:DNLI) and Washington University School of Medicine in St. Louis researchers led by David Holtzman found that an anti-APOE...
BioCentury | Feb 17, 2021
Product Development

AZ-Oxford COVID-19 vaccine authorized by WHO; plus vaccine updates from Novavax-SK, J&J and Pfizer-BioNTech

The WHO has granted emergency use listing (EUL) to the adenoviral vector COVID-19 vaccine developed by AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and the University of Oxford. The authorization covers the versions manufactured by the Serum Institute...
BioCentury | Feb 6, 2021
Product Development

Picking vaccine strategies that could hold up to COVID variants

As new mutations to SARS-CoV-2 emerge faster than many countries can vaccinate their populations,  pressure is mounting on vaccine developers to pre-empt the variants before they take hold, let alone are properly characterized. And while...
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...
Items per page:
1 - 10 of 3175
BioCentury | Feb 27, 2021
Product Development

Feb. 26 COVID Quick Takes: FDA wants more data from Merck; plus ‘clear efficacy’ for Regeneron and updates from GSK, Lilly, Novavax

Merck & Co. Inc. (NYSE:MRK) no longer expects to supply the U.S. with COVID-19 therapy MK-7110 by June 30 after FDA told the company additional data would be needed to support emergency use authorization. MK-7110,...
BioCentury | Feb 27, 2021
Distillery Therapeutics

Trastuzumab-RNA polymerase inhibitor conjugate for breast cancer with low HER2 expression

DISEASE CATEGORY: Cancer INDICATION: Breast cancer An antibody-drug conjugate comprising anti-HER2 antibody trastuzumab linked to POLR2A inhibitor α-amanitin could treat breast cancer with low HER2 expression and heterozygous loss of chromosome 17p. In a panel...
BioCentury | Feb 26, 2021
Product Development

Zaks’ impending departure but the latest milestone as Moderna charts year ahead

As Moderna prioritizes maximizing the reach of its COVID-19 vaccine, Thursday’s announcement of the impending departure of longtime CMO Tal Zaks caps a transformational 14 months for the mRNA company and comes during a year when...
BioCentury | Feb 26, 2021
Product Development

Actions COVID vaccine makers are taking to tackle variants: Data Byte

COVID-19 vaccine developers are taking multiple approaches to combat emerging SARS-CoV-2 variants, ranging from administering additional booster shots of authorized vaccines to developing variant-specific...
BioCentury | Feb 23, 2021
Product Development

Trials testing COVID-19 vaccines in kids: Data Byte

At least seven COVID-19 vaccines are or will soon be tested in pediatric volunteers, according to BioCentury’s COVID-19 Clinical Trials Dashboard. Two of the trials have already produced readouts that included pediatric subjects, but the pediatric cohort...
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 19, 2021
Translation in Brief

mAb reduces amyloid plaques without hemorrhage; plus Dyno and Ally’s AAV technologies and more

Alzheimer’s disease immunotherapy reduces β-amyloid without increasing brain bleedingPublished in Science Translational Medicine, Denali Therapeutics Inc. (NASDAQ:DNLI) and Washington University School of Medicine in St. Louis researchers led by David Holtzman found that an anti-APOE...
BioCentury | Feb 17, 2021
Product Development

AZ-Oxford COVID-19 vaccine authorized by WHO; plus vaccine updates from Novavax-SK, J&J and Pfizer-BioNTech

The WHO has granted emergency use listing (EUL) to the adenoviral vector COVID-19 vaccine developed by AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and the University of Oxford. The authorization covers the versions manufactured by the Serum Institute...
BioCentury | Feb 6, 2021
Product Development

Picking vaccine strategies that could hold up to COVID variants

As new mutations to SARS-CoV-2 emerge faster than many countries can vaccinate their populations,  pressure is mounting on vaccine developers to pre-empt the variants before they take hold, let alone are properly characterized. And while...
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...
Items per page:
1 - 10 of 3175