UK to Start World’s First COVID-19 Human Challenge Trial
A specially convened UK clinical trial ethics committee has given the go-ahead for a COVID-19 human challenge study that is slated to start within weeks to help inform further vaccine…
Zients Fronts Biden Administration’s Restructured Operation Warp Speed
Created by the prior administration to accelerate development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics, Operation Warp Speed (OWS) is an initiative in search of a new name,…
Report Shows 7.9 Percent of Drugs Ultimately Won Regulatory Approval Over Last Decade
The number of clinical trials that make it through to regulatory approval over the past decade is less than 8 percent, according to a new report on clinical success rates.…
EU Launches Vaccine Incubator to Take on Coronavirus Variants
The EU yesterday unveiled a plan to speed up regulatory approvals and manufacturing of vaccines against emerging strains of the SARS-CoV-2 virus that causes COVID-19. Source: Drug Industry Daily
GSK and Vir Biotechnology Expand Monoclonal Antibody Partnership
GlaxoSmithKline (GSK) and Vir Biotechnology have teamed up to develop monoclonal antibodies for respiratory viruses, building off an existing agreement struck last year to develop COVID-19 therapies. Source: Drug Industry…
Woodcock Rebuffs Proposed ‘Firewall’ Between FDA Staff Following Aducanumab Dispute
Acting FDA Commissioner Janet Woodcock rejected a proposal to put up a “firewall” between FDA staff involved in pre-submission interactions and staff working on post-submission drug and biologic reviews and…
European Commission Signs New Supply Deals With Pfizer and Moderna
The EU has struck new supply agreements with Moderna and Pfizer, boosting its total COVID-19 vaccine arsenal to up to 2.6 billion doses, enough to inoculate the bloc’s 446 million…
New York Contract Manufacturer Hit for Repeat Observations
Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct.…
FDA Issues Final Guidance on New Review Path for Safer Technologies
The FDA is introducing a new review program for medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition…
TGA Investigates COVID-19 Tests and Emerging Variants
Australia’s Therapeutic Goods Administration is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in the Australian Register of Therapeutic Goods to ensure that they can detect…