Adjuvanted H1N1 Vaccine Excites FDA Panel, But Jury Is Still Out

Pending further data on adjuvants from firms and NIH, FDA's Vaccines and Related Biological Products Advisory Committee is comfortable with FDA's plans to license unadjuvanted H1N1 flu vaccines under the strain change process.

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
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During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.