BioCentury | Mar 15, 2021
Product Development

Alzheimer’s data from Lilly and Biogen converge on small effect for amyloid targeting

...getting any hint of benefit across multiple metrics...
BioCentury | Mar 13, 2021
Product Development

Long COVID therapies are starting to populate a sparse pipeline

...as defined by four different symptom scoring metrics...
...for its study; CytoDyn is using patient-reported metrics...
BioCentury | Mar 12, 2021
Politics, Policy & Law

PDUFA VII to feature $4M fee, focus on cell, gene therapies

...application review process.” FDA officials have “discussed a proposal to establish formal timelines and reporting metrics...
BioCentury | Mar 12, 2021
Product Development

Vir’s mAb on par with Lilly combo in early stage patients

Vir’s COVID mAb has produced some of the strongest data to date in high-risk outpatients, reducing hospitalization or death by 85% (p=0.002). Vir Biotechnology Inc. (NASDAQ:VIR) and partner GlaxoSmithKline...
BioCentury | Mar 6, 2021
Product Development

Cue’s OTC home molecular test opens the door to routine self-screening

...marks a turning point for COVID-19 screening via a system that encourages repeat home testing.Performance metrics...
BioCentury | Mar 5, 2021
Product Development

Lilly’s tirzepatide more potent than Novo’s semaglutide, but higher discontinuation: Data Byte

...Senior Editor Head-to-head and cross-trial comparisons indicate Lilly’s tirzepatide bests Novo’s semaglutide on multiple efficacy metrics...
BioCentury | Feb 6, 2021
Politics, Policy & Law

Biotech isn’t tech; M&A isn’t all the same

Rep. Katie Porter (D-Calif.) released a report last week that crystallized two urgent tasks for the biopharma industry: to prevent misconceptions about M&A from becoming accepted as facts, and more broadly, to forge a bipartisan...
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 13, 2021
Politics, Policy & Law

BIO, PhRMA ‘pause’ political giving

In the wake of the storming of the U.S. Capitol, BIO and PhRMA have joined other trade associations and U.S. companies in reassessing their criteria for making political contributions. The biopharma trade associations have not...
BioCentury | Jan 12, 2021
Regulation

HHS imposes new review timeline report policy on FDA

...require FDA to collect and report data about the length of new drug reviews using metrics...
Items per page:
1 - 10 of 419
BioCentury | Mar 15, 2021
Product Development

Alzheimer’s data from Lilly and Biogen converge on small effect for amyloid targeting

...getting any hint of benefit across multiple metrics...
BioCentury | Mar 13, 2021
Product Development

Long COVID therapies are starting to populate a sparse pipeline

...as defined by four different symptom scoring metrics...
...for its study; CytoDyn is using patient-reported metrics...
BioCentury | Mar 12, 2021
Politics, Policy & Law

PDUFA VII to feature $4M fee, focus on cell, gene therapies

...application review process.” FDA officials have “discussed a proposal to establish formal timelines and reporting metrics...
BioCentury | Mar 12, 2021
Product Development

Vir’s mAb on par with Lilly combo in early stage patients

Vir’s COVID mAb has produced some of the strongest data to date in high-risk outpatients, reducing hospitalization or death by 85% (p=0.002). Vir Biotechnology Inc. (NASDAQ:VIR) and partner GlaxoSmithKline...
BioCentury | Mar 6, 2021
Product Development

Cue’s OTC home molecular test opens the door to routine self-screening

...marks a turning point for COVID-19 screening via a system that encourages repeat home testing.Performance metrics...
BioCentury | Mar 5, 2021
Product Development

Lilly’s tirzepatide more potent than Novo’s semaglutide, but higher discontinuation: Data Byte

...Senior Editor Head-to-head and cross-trial comparisons indicate Lilly’s tirzepatide bests Novo’s semaglutide on multiple efficacy metrics...
BioCentury | Feb 6, 2021
Politics, Policy & Law

Biotech isn’t tech; M&A isn’t all the same

Rep. Katie Porter (D-Calif.) released a report last week that crystallized two urgent tasks for the biopharma industry: to prevent misconceptions about M&A from becoming accepted as facts, and more broadly, to forge a bipartisan...
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 13, 2021
Politics, Policy & Law

BIO, PhRMA ‘pause’ political giving

In the wake of the storming of the U.S. Capitol, BIO and PhRMA have joined other trade associations and U.S. companies in reassessing their criteria for making political contributions. The biopharma trade associations have not...
BioCentury | Jan 12, 2021
Regulation

HHS imposes new review timeline report policy on FDA

...require FDA to collect and report data about the length of new drug reviews using metrics...
Items per page:
1 - 10 of 419