BioCentury | Apr 20, 2018
Product Development

Lessons from the ECHO chamber

Lessons from the failure of ECHO-301 go beyond the prospects of combining IDO1 and PD-1 inhibition to treat cancer. The broader concern is for the gamut of Phase I/II trials testing PD-1 combinations, many of...
BioCentury | Feb 4, 2016
Politics & Policy

IOM addresses mitochondrial replacement therapy

The Institute of Medicine division of the National Academies of Sciences, Engineering and Medicine released a report Wednesday addressing ethical, social and policy considerations surrounding the clinical use of mitochondrial replacement therapy (MRT). The report,...
BioCentury | Jan 28, 2016
Strategy

CIRM's endgame

In the latest effort to make good on promises made to the voters who created the California Institute for Regenerative Medicine (CIRM) in 2004, the agency has approved a strategic plan spelling out concrete goals...
BioCentury | Apr 27, 2015
Politics, Policy & Law

Speed trials

The 2014 West Africa Ebola outbreak is stimulating the fastest vaccine development efforts ever attempted, demonstrating the power of an emerging model that combines the expertise, capabilities and resources of experienced pharma companies, government biomedical...
BioCentury | Apr 27, 2015
Politics, Policy & Law

Learning from Ebola

The knowledge that, as bad as Ebola has been, it could have been far worse, is prompting leaders in government, industry and NGOs to discuss the need for new institutions or collaborations to conduct surveillance...
BioCentury | Apr 7, 2015
Politics & Policy

IOM names Hamburg foreign secretary

The National Academy of Sciences' Institute of Medicine appointed former FDA Commissioner Margaret Hamburg as its foreign secretary, a part-time position, effective Monday. Hamburg's term runs through through June 30, 2019. She succeeds Jo Ivey...
BioCentury | Jan 16, 2015
Politics & Policy

IOM publishes guidelines for sharing clinical trial data

A Pfizer Inc. (NYSE:PFE); a GlaxoSmithKline plc (LSE:GSK; NYSE:GSK); and the Yale School of Medicine and Johnson & Johnson (NYSE:JNJ). BC Staff...
BioCentury | Sep 15, 2014
Strategy

Cancer: Cost and quality

Early data from the first of several U.S. experiments with cancer payment reform offer the tantalizing possibility that drug companies could actually benefit from schemes designed to reward oncologists for outcomes as well as cost...
BioCentury | May 23, 2014
Politics & Policy

NIH to reduce RAC's role

NIH Director Francis Collins said the agency will minimize the number of human gene transfer protocols that will be reviewed by the agency's Recombinant DNA Advisory Committee. NIH established RAC in 1974 to provide increased...
BioCentury | May 19, 2014
Regulation

Getting to certain

As FDA moves closer to installing a new risk-benefit framework for drug reviews, it still is grappling with how to address uncertainties in the process. Last week, the agency and the Institute of Medicine concluded...
Items per page:
1 - 10 of 114
BioCentury | Apr 20, 2018
Product Development

Lessons from the ECHO chamber

Lessons from the failure of ECHO-301 go beyond the prospects of combining IDO1 and PD-1 inhibition to treat cancer. The broader concern is for the gamut of Phase I/II trials testing PD-1 combinations, many of...
BioCentury | Feb 4, 2016
Politics & Policy

IOM addresses mitochondrial replacement therapy

The Institute of Medicine division of the National Academies of Sciences, Engineering and Medicine released a report Wednesday addressing ethical, social and policy considerations surrounding the clinical use of mitochondrial replacement therapy (MRT). The report,...
BioCentury | Jan 28, 2016
Strategy

CIRM's endgame

In the latest effort to make good on promises made to the voters who created the California Institute for Regenerative Medicine (CIRM) in 2004, the agency has approved a strategic plan spelling out concrete goals...
BioCentury | Apr 27, 2015
Politics, Policy & Law

Speed trials

The 2014 West Africa Ebola outbreak is stimulating the fastest vaccine development efforts ever attempted, demonstrating the power of an emerging model that combines the expertise, capabilities and resources of experienced pharma companies, government biomedical...
BioCentury | Apr 27, 2015
Politics, Policy & Law

Learning from Ebola

The knowledge that, as bad as Ebola has been, it could have been far worse, is prompting leaders in government, industry and NGOs to discuss the need for new institutions or collaborations to conduct surveillance...
BioCentury | Apr 7, 2015
Politics & Policy

IOM names Hamburg foreign secretary

The National Academy of Sciences' Institute of Medicine appointed former FDA Commissioner Margaret Hamburg as its foreign secretary, a part-time position, effective Monday. Hamburg's term runs through through June 30, 2019. She succeeds Jo Ivey...
BioCentury | Jan 16, 2015
Politics & Policy

IOM publishes guidelines for sharing clinical trial data

A Pfizer Inc. (NYSE:PFE); a GlaxoSmithKline plc (LSE:GSK; NYSE:GSK); and the Yale School of Medicine and Johnson & Johnson (NYSE:JNJ). BC Staff...
BioCentury | Sep 15, 2014
Strategy

Cancer: Cost and quality

Early data from the first of several U.S. experiments with cancer payment reform offer the tantalizing possibility that drug companies could actually benefit from schemes designed to reward oncologists for outcomes as well as cost...
BioCentury | May 23, 2014
Politics & Policy

NIH to reduce RAC's role

NIH Director Francis Collins said the agency will minimize the number of human gene transfer protocols that will be reviewed by the agency's Recombinant DNA Advisory Committee. NIH established RAC in 1974 to provide increased...
BioCentury | May 19, 2014
Regulation

Getting to certain

As FDA moves closer to installing a new risk-benefit framework for drug reviews, it still is grappling with how to address uncertainties in the process. Last week, the agency and the Institute of Medicine concluded...
Items per page:
1 - 10 of 114