Archive for February 2021
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 and treatment research. Source: Drug Industry Daily
Read MoreZients 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, but it already has a new lineup of prominent individuals chosen by the Biden administration, including a new front man, Jeffrey Zients. Source: Drug Industry…
Read MoreReport 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. Source: Drug Industry Daily
Read MoreEU 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
Read MoreGSK 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 Daily
Read MoreWoodcock 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 decisions, defending the agency’s collaboration with sponsors as critical to the development process. Source: Drug Industry Daily
Read MoreEuropean 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 citizen many times over, but it is promising to share with “neighbors and partners.” Source: Drug Industry Daily
Read MoreNew 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. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Source: The GMP Letter
Read MoreFDA 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 deemed less serious than those eligible for the breakthrough devices program. Source: The GMP Letter
Read MoreTGA 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 emerging SARS-CoV-2 genetic variants. Source: The GMP Letter
Read More