Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Dearth Of Seasonal Flu Adds Uncertainty To Vaccine Strain Selection For Next Season

Executive Summary

Low influenza activity in the face of COVID-19 mitigation measures has made it more difficult to predict which strains may become predominant, but US FDA advisory committee unanimously endorses WHO recommendations for influenza A and B strains to be included in US trivalent and quadrivalent vaccines.

You may also be interested in...



Global Regulatory Harmonization Discussions Ongoing About COVID-19 Vaccine Boosters

US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.

Nagoya Protocol Complicates Seasonal Flu Vaccine Manufacturing And Could Slow Future Pandemic Responses

Industry experts contrast the multilateral response to COVID-19, which included rapid disclosure of the SARS-CoV-2 genetic sequence, with delays and complexities in accessing seasonal influenza viruses and other pathogens originating in countries that have adopted the Nagoya Protocol and implemented access and benefit-sharing legislation.

Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’

Topics

Related Companies

UsernamePublicRestriction

Register

PS143948

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel