BioCentury | Feb 15, 2020
Product Development

WHO mapping out COVID-19 vaccines

Scientists from biopharma companies, universities and regulatory agencies met at the WHO Feb. 11-12 to draw a roadmap for the development of vaccines to protect against COVID-19 amid a rapidly shifting terrain. While knowledge about...
BioCentury | Feb 14, 2020
Regulation

Controversy over stretching expanded access to off-label uses

Compassionate use is no exception to the axiom that sooner or later, someone will find an unexpected and controversial way to bend any law or regulation for unanticipated purposes. FDA’s expanded access, or compassionate use,...
BioCentury | Feb 13, 2020
Politics, Policy & Law

Catalyzing controversy: FDA emails challenge its claims that price plays no role in approvals

Over 200 pages of emails released as a result of litigation against FDA and HHS challenge FDA’s claims that it does not consider price when making approval decisions. The emails pull back the curtain on...
BioCentury | Feb 12, 2020
Tools & Techniques

NCATS, FDA meeting shines light on AAV manufacturing innovation

Technologies highlighted at a NCATS-FDA AAV manufacturing workshop could ramp up the production and durability of gene therapies, but questions remain about who will test drive these innovations and where the next wave of them...
BioCentury | Feb 11, 2020
Politics, Policy & Law

Senate bill introduced to close Orphan drug ‘loophole’

Legislation introduced Tuesday in the Senate seeks to tighten the little-used cost recovery pathway to obtaining Orphan Drug designation in the U.S. The Fairness in Orphan Drug Exclusivity Act is identical to a bill, H.R....
BioCentury | Feb 10, 2020
Politics, Policy & Law

Trump budget request claims $135B in drug savings, calls for NIH cut that won’t happen, flatlines FDA

President Donald Trump’s FY21 budget includes provisions the administration says will save $135 billion in drug costs over 10 years. The White House recycled ideas it has proposed over the last two years but did...
BioCentury | Feb 8, 2020
Product Development

Coronavirus update: outbreak has not disrupted drug supplies, vaccine development advancing

The 2019-nCoV outbreak has not adversely affected supplies of drugs or active pharmaceutical ingredients to the U.S., FDA Commissioner Stephen Hahn said Friday. “At this moment we have received no reports from manufacturers of disruptions...
BioCentury | Feb 6, 2020
Product Development

2019-nCoV diagnostics ramp up in China, globally

Companies and government organizations have started large-scale deployment of diagnostics to diagnose and screen for 2019-nCoV. If secondary transmission of the virus occurs on a large scale outside China, diagnostics will be essential for effective...
BioCentury | Feb 5, 2020
Politics, Policy & Law

FDA’s Pazdur supports expanded access for approved drugs

Richard Pazdur, director of FDA’s Oncology Center of Excellence, Wednesday said he supports authorizing expanded access requests for unapproved uses of approved medicines. Although physicians can prescribe drugs for off-label indications, it can be difficult...
BioCentury | Feb 5, 2020
Regulation

Regulatory response: FDA authorizes emergency 2019-nCoV diagnostic, EMA activates emergency plan

FDA and EMA each unveiled measures Tuesday to combat the 2019-nCoV outbreak, with the U.S. agency issuing emergency use authorization for a diagnostic and its European counterpart activating its emerging health threats management plan. Both...
Items per page:
1 - 10 of 1069
BioCentury | Feb 15, 2020
Product Development

WHO mapping out COVID-19 vaccines

Scientists from biopharma companies, universities and regulatory agencies met at the WHO Feb. 11-12 to draw a roadmap for the development of vaccines to protect against COVID-19 amid a rapidly shifting terrain. While knowledge about...
BioCentury | Feb 14, 2020
Regulation

Controversy over stretching expanded access to off-label uses

Compassionate use is no exception to the axiom that sooner or later, someone will find an unexpected and controversial way to bend any law or regulation for unanticipated purposes. FDA’s expanded access, or compassionate use,...
BioCentury | Feb 13, 2020
Politics, Policy & Law

Catalyzing controversy: FDA emails challenge its claims that price plays no role in approvals

Over 200 pages of emails released as a result of litigation against FDA and HHS challenge FDA’s claims that it does not consider price when making approval decisions. The emails pull back the curtain on...
BioCentury | Feb 12, 2020
Tools & Techniques

NCATS, FDA meeting shines light on AAV manufacturing innovation

Technologies highlighted at a NCATS-FDA AAV manufacturing workshop could ramp up the production and durability of gene therapies, but questions remain about who will test drive these innovations and where the next wave of them...
BioCentury | Feb 11, 2020
Politics, Policy & Law

Senate bill introduced to close Orphan drug ‘loophole’

Legislation introduced Tuesday in the Senate seeks to tighten the little-used cost recovery pathway to obtaining Orphan Drug designation in the U.S. The Fairness in Orphan Drug Exclusivity Act is identical to a bill, H.R....
BioCentury | Feb 10, 2020
Politics, Policy & Law

Trump budget request claims $135B in drug savings, calls for NIH cut that won’t happen, flatlines FDA

President Donald Trump’s FY21 budget includes provisions the administration says will save $135 billion in drug costs over 10 years. The White House recycled ideas it has proposed over the last two years but did...
BioCentury | Feb 8, 2020
Product Development

Coronavirus update: outbreak has not disrupted drug supplies, vaccine development advancing

The 2019-nCoV outbreak has not adversely affected supplies of drugs or active pharmaceutical ingredients to the U.S., FDA Commissioner Stephen Hahn said Friday. “At this moment we have received no reports from manufacturers of disruptions...
BioCentury | Feb 6, 2020
Product Development

2019-nCoV diagnostics ramp up in China, globally

Companies and government organizations have started large-scale deployment of diagnostics to diagnose and screen for 2019-nCoV. If secondary transmission of the virus occurs on a large scale outside China, diagnostics will be essential for effective...
BioCentury | Feb 5, 2020
Politics, Policy & Law

FDA’s Pazdur supports expanded access for approved drugs

Richard Pazdur, director of FDA’s Oncology Center of Excellence, Wednesday said he supports authorizing expanded access requests for unapproved uses of approved medicines. Although physicians can prescribe drugs for off-label indications, it can be difficult...
BioCentury | Feb 5, 2020
Regulation

Regulatory response: FDA authorizes emergency 2019-nCoV diagnostic, EMA activates emergency plan

FDA and EMA each unveiled measures Tuesday to combat the 2019-nCoV outbreak, with the U.S. agency issuing emergency use authorization for a diagnostic and its European counterpart activating its emerging health threats management plan. Both...
Items per page:
1 - 10 of 1069