BioCentury | Oct 31, 2020
Regulation

Expanding access to COVID-19 vaccines

As lightning-quick vaccine development comes close to catching up with a runaway pandemic, FDA must quickly decide how it will respond to the first clear signs that a vaccine candidate may be effective.  ...
BioCentury | Oct 6, 2020
Politics, Policy & Law

Trump treatment resurfaces compassionate use quandaries

President Donald Trump’s treatment with an investigational drug from Regeneron resurfaces long-standing ethical quandaries involving compassionate use and the allocation of scarce drugs. The REGN-COV2...
BioCentury | Sep 9, 2020
Product Development

Roche’s Anderson wants industry to keep its foot on the gas for infectious disease, post-pandemic: a BioCentury audio interview

There will be no turning back to business as usual for drug developers and regulators after COVID-19, according to Bill Anderson, CEO of Roche Pharmaceuticals. But while he’s optimistic about speeding up timelines and changing...
BioCentury | Aug 4, 2020
Product Development

Warp Speed, decentralized trials & SPACs: a BioCentury podcast

After pledging up to $2.1 billion to a preclinical vaccine from Sanofi and GSK, the U.S. government’s total commitment for COVID-19 vaccine candidates now stands at $8.3 billion across seven vaccines based on four different...
BioCentury | Jun 26, 2020
Product Development

21st century pandemic, prehistoric clinical trials

The U.S. is trying to fight a 21st century pandemic with prehistoric clinical trials -- and achieving the kind of efficiency you might expect. In the last six months, tens of thousand of patients have...
BioCentury | May 21, 2020
Product Development

With AZ deal, Operation Warp Speed takes first step to train guns on coronavirus

Operation Warp Speed, along with its promises and dangers, is coming into sharp focus. Its investment of up to $1.2 billion in a COVID-19 vaccine candidate is testimony to the risks it is prepared to...
BioCentury | Sep 27, 2019
Politics, Policy & Law

Trump administration to modernize flu vaccines via government buying power

The U.S. government is laying plans to harness its buying power and applied research capabilities to pull influenza vaccine development and manufacturing into the 21st century. The goals are to enhance protection against seasonal flu,...
BioCentury | Aug 31, 2019
Product Development

Digital tech meets the patient: first movers are bringing digital to biopharma

At the leading edge of drug development, digital health is starting to make waves, bringing products and tools that offer patients a new level of personalized medicine. At the same time, these technologies give the...
BioCentury | Jun 14, 2019
Company News

bluebird prices β thalassemia gene therapy, first to put majority of revenues at risk

bluebird bio could be the first company to test an outcomes-based pricing model for a gene therapy where the vast majority of the price is at risk. On Friday, bluebird bio Inc. (NASDAQ:BLUE) announced the...
BioCentury | Jun 5, 2019
Finance

Conflicts over scale, response to foreign threats and espionage against NIH research at Senate hearing

A June 5 Senate Finance Committee hearing saw sparks fly over allegations of spying, with two Republican senators accusing the Chinese government of engaging in large-scale espionage against U.S. taxpayer-funded research, and a Democrat countering...
Items per page:
1 - 10 of 99
BioCentury | Oct 31, 2020
Regulation

Expanding access to COVID-19 vaccines

As lightning-quick vaccine development comes close to catching up with a runaway pandemic, FDA must quickly decide how it will respond to the first clear signs that a vaccine candidate may be effective.  ...
BioCentury | Oct 6, 2020
Politics, Policy & Law

Trump treatment resurfaces compassionate use quandaries

President Donald Trump’s treatment with an investigational drug from Regeneron resurfaces long-standing ethical quandaries involving compassionate use and the allocation of scarce drugs. The REGN-COV2...
BioCentury | Sep 9, 2020
Product Development

Roche’s Anderson wants industry to keep its foot on the gas for infectious disease, post-pandemic: a BioCentury audio interview

There will be no turning back to business as usual for drug developers and regulators after COVID-19, according to Bill Anderson, CEO of Roche Pharmaceuticals. But while he’s optimistic about speeding up timelines and changing...
BioCentury | Aug 4, 2020
Product Development

Warp Speed, decentralized trials & SPACs: a BioCentury podcast

After pledging up to $2.1 billion to a preclinical vaccine from Sanofi and GSK, the U.S. government’s total commitment for COVID-19 vaccine candidates now stands at $8.3 billion across seven vaccines based on four different...
BioCentury | Jun 26, 2020
Product Development

21st century pandemic, prehistoric clinical trials

The U.S. is trying to fight a 21st century pandemic with prehistoric clinical trials -- and achieving the kind of efficiency you might expect. In the last six months, tens of thousand of patients have...
BioCentury | May 21, 2020
Product Development

With AZ deal, Operation Warp Speed takes first step to train guns on coronavirus

Operation Warp Speed, along with its promises and dangers, is coming into sharp focus. Its investment of up to $1.2 billion in a COVID-19 vaccine candidate is testimony to the risks it is prepared to...
BioCentury | Sep 27, 2019
Politics, Policy & Law

Trump administration to modernize flu vaccines via government buying power

The U.S. government is laying plans to harness its buying power and applied research capabilities to pull influenza vaccine development and manufacturing into the 21st century. The goals are to enhance protection against seasonal flu,...
BioCentury | Aug 31, 2019
Product Development

Digital tech meets the patient: first movers are bringing digital to biopharma

At the leading edge of drug development, digital health is starting to make waves, bringing products and tools that offer patients a new level of personalized medicine. At the same time, these technologies give the...
BioCentury | Jun 14, 2019
Company News

bluebird prices β thalassemia gene therapy, first to put majority of revenues at risk

bluebird bio could be the first company to test an outcomes-based pricing model for a gene therapy where the vast majority of the price is at risk. On Friday, bluebird bio Inc. (NASDAQ:BLUE) announced the...
BioCentury | Jun 5, 2019
Finance

Conflicts over scale, response to foreign threats and espionage against NIH research at Senate hearing

A June 5 Senate Finance Committee hearing saw sparks fly over allegations of spying, with two Republican senators accusing the Chinese government of engaging in large-scale espionage against U.S. taxpayer-funded research, and a Democrat countering...
Items per page:
1 - 10 of 99