BioCentury | Jul 7, 2020
Politics, Policy & Law

FDA credibility on the line with White House pressure on hydroxychloroquine

Demands from President Donald Trump that FDA issue a second Emergency Use Authorization for the use of hydroxychloroquine to treat COVID-19 test agency chief Stephen Hahn’s commitment to public health again, and pose challenges to...
BioCentury | Jun 23, 2020
Regulation

FDA pilot project aims to provide symptom data to cancer patients

FDA Tuesday launched a pilot version of Project Patient Voice, a website that will give patients and physicians information that isn’t on labels about patient-reported symptoms for cancer drugs. Project Patient Voice will present sponsor-provided...
BioCentury | Jun 19, 2020
Politics, Policy & Law

House lawmakers call for transparency, independent review for COVID-19 vaccine program

A trio of Democrats on the House Oversight Committee are asking FDA for more information on how the agency plans to evaluate and deploy COVID-19 vaccines, in an effort to ensure the process is transparent,...
BioCentury | Jun 19, 2020
Regulation

FDA guidance aims to help sponsors salvage trials disrupted by COVID-19

As COVID-19 safety concerns and social distancing measures continue to disrupt clinical trials around the U.S., FDA has released guidance to help investigators adapt the design and analysis of affected studies. By the end of...
BioCentury | Jun 19, 2020
Product Development

BEATing COVID-19 from home

As knowledge regarding the natural history of COVID-19 continues to evolve, biopharmas are looking to real-world data generated from the BEAT19 initiative to inform clinical trial design for COVID-19 therapies. Behavior, Environment and Treatments for...
BioCentury | Jun 17, 2020
Product Development

Trump administration lays out path to 300M COVID-19 doses by January, safety questions linger

The Trump administration Tuesday presented a high-level road map to its plans to produce 300 million COVID-19 vaccine doses by January. In a briefing for reporters, senior administration officials involved with Operation Warp Speed stressed...
BioCentury | Jun 17, 2020
Regulation

International regulators concerned by poor COVID-19 trials, advocate master protocols

Regulators around the world are concerned that small, underpowered and discontinued trials of COVID-19 therapies are crowding out studies that could provide definitive results, according to a readout provided by EMA from a June 12...
BioCentury | Jun 15, 2020
Regulation

Asserting its independence, FDA revokes chloroquine authorizations

FDA took more than six weeks to rescind the EUA for hydroxychloroquine and chloroquine after the agency first raised concerns over the safety of the malaria drugs to treat COVID-19. The move reverses a decision...
BioCentury | Jun 12, 2020
Product Development

AZ, BioNTech continue to build capacity to manufacture COVID-19 vaccines

Manufacturing deals for COVID-19 vaccine candidates continued to gain momentum Thursday, with two of the most advanced companies entering deals that will help them expand capacity to make their products. Emergent BioSolutions Inc. (NYSE:EBS) announced...
BioCentury | Jun 11, 2020
Regulation

FDA planning to work with sponsors to salvage trials damaged by COVID-19

COVID-19 has disrupted clinical trials around the world, causing sponsors to wrap up studies sooner than anticipated, modify protocols to allow for remote collection of data, and in some cases contemplate methods to compensate for...
Items per page:
1 - 10 of 1137
BioCentury | Jul 7, 2020
Politics, Policy & Law

FDA credibility on the line with White House pressure on hydroxychloroquine

Demands from President Donald Trump that FDA issue a second Emergency Use Authorization for the use of hydroxychloroquine to treat COVID-19 test agency chief Stephen Hahn’s commitment to public health again, and pose challenges to...
BioCentury | Jun 23, 2020
Regulation

FDA pilot project aims to provide symptom data to cancer patients

FDA Tuesday launched a pilot version of Project Patient Voice, a website that will give patients and physicians information that isn’t on labels about patient-reported symptoms for cancer drugs. Project Patient Voice will present sponsor-provided...
BioCentury | Jun 19, 2020
Politics, Policy & Law

House lawmakers call for transparency, independent review for COVID-19 vaccine program

A trio of Democrats on the House Oversight Committee are asking FDA for more information on how the agency plans to evaluate and deploy COVID-19 vaccines, in an effort to ensure the process is transparent,...
BioCentury | Jun 19, 2020
Regulation

FDA guidance aims to help sponsors salvage trials disrupted by COVID-19

As COVID-19 safety concerns and social distancing measures continue to disrupt clinical trials around the U.S., FDA has released guidance to help investigators adapt the design and analysis of affected studies. By the end of...
BioCentury | Jun 19, 2020
Product Development

BEATing COVID-19 from home

As knowledge regarding the natural history of COVID-19 continues to evolve, biopharmas are looking to real-world data generated from the BEAT19 initiative to inform clinical trial design for COVID-19 therapies. Behavior, Environment and Treatments for...
BioCentury | Jun 17, 2020
Product Development

Trump administration lays out path to 300M COVID-19 doses by January, safety questions linger

The Trump administration Tuesday presented a high-level road map to its plans to produce 300 million COVID-19 vaccine doses by January. In a briefing for reporters, senior administration officials involved with Operation Warp Speed stressed...
BioCentury | Jun 17, 2020
Regulation

International regulators concerned by poor COVID-19 trials, advocate master protocols

Regulators around the world are concerned that small, underpowered and discontinued trials of COVID-19 therapies are crowding out studies that could provide definitive results, according to a readout provided by EMA from a June 12...
BioCentury | Jun 15, 2020
Regulation

Asserting its independence, FDA revokes chloroquine authorizations

FDA took more than six weeks to rescind the EUA for hydroxychloroquine and chloroquine after the agency first raised concerns over the safety of the malaria drugs to treat COVID-19. The move reverses a decision...
BioCentury | Jun 12, 2020
Product Development

AZ, BioNTech continue to build capacity to manufacture COVID-19 vaccines

Manufacturing deals for COVID-19 vaccine candidates continued to gain momentum Thursday, with two of the most advanced companies entering deals that will help them expand capacity to make their products. Emergent BioSolutions Inc. (NYSE:EBS) announced...
BioCentury | Jun 11, 2020
Regulation

FDA planning to work with sponsors to salvage trials damaged by COVID-19

COVID-19 has disrupted clinical trials around the world, causing sponsors to wrap up studies sooner than anticipated, modify protocols to allow for remote collection of data, and in some cases contemplate methods to compensate for...
Items per page:
1 - 10 of 1137