Scrip 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
UsernamePublicRestriction

US NIH studies find high response with one dose of H1N1 vaccine

This article was originally published in Scrip

Executive Summary

Early data from US National Institutes of Health-sponsored studies of two A/H1N1 influenza vaccines show a high immunogenic response with only one dose, similar to results seen in vaccine manufacturers' own tests, US government officials announced on September 11th.

You may also be interested in...



Cyramza First-Line Lung Cancer Bid Raises Clinical Practice Questions

Lilly is positioning the ramucirumab/erlotinib combination as a first-line alternative for EGFR-positive non-small cell lung cancer that preserves AstraZeneca’s Tagrisso for second-line use; advisory committee members vote 6-5 for expanded indication but express skepticism about adoption.

US FDA Divided On Expanded Access Requests For Off-Label Use Of Approved Drugs

Agency’s clinical experts favor granting access under regulations intended for investigational drugs but ‘lawyers want consistency under the law,’ FDA’s Woodcock says; use of the expanded access pathway for approved agents is generally unnecessary but may provide sponsors with some regulatory cover, external experts say.

Rare Disease Gene Therapy Guidance Gives More Flexibility On Placebo-Controlled Trials

US FDA declined stakeholder requests to remove recommendation for placebo controls from a final guidance but added qualifying language on their use ‘when feasible.’ While the agency excised language on biomarker validation from the final guidance, it reaffirmed the need for early establishment of critical quality attributes and critical process parameters.

Topics

Related Companies

UsernamePublicRestriction

Register

SC004472

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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