FDA pulls license for chikungunya vaccine

The Food and Drug Administration's Center for Biologics Evaluation and Research has suspended the biologics license for Ixchiq, a live-attenuated chikungunya vaccine made by Valneva that was cleared under accelerated approval less than two years ago. The move follows mounting reports of "serious safety concerns" related to the vaccine, which it says cause chikungunya-like illness in some people who received the vaccine.

The FDA says that there have been 21 hospitalizations and three deaths linked to the vaccine — and that its clinical benefit hasn't been verified in confirmatory clinical studies. In May, the agency recommended pausing use of the vaccine in people aged 60 and over but removed the pause earlier this month.

drug discovery

'Multifunctionality' will drive a new wave of drug development

Drug discovery is shifting from single-target therapies toward multifunctional structures that combine distinct modalities, opine Sasha Ebrahimi, a scientific leader at GSK, and Milan Mrksich, a professor studying such therapies at Northwestern University.

From bispecific antibodies and PROTACs to CRISPR systems packaged in lipid nanoparticles, they say, these hybrid formats can guide drugs to precise locations while delivering therapeutic payloads — which could mean more effective and precise treatments, opportunities for repurposing, and even solutions for "undruggable" diseases.

But the complexity of these platforms raise fresh scientific and regulatory challenges. Would these sorts of drugs require that each component be tested individually, as well as in combination — or will a new, shortened regulatory pathway be possible?

"Rather than thinking in terms of single targets or isolated therapeutic classes, we now have the opportunity and imperative to think in terms of combinations," they write.

antidepressants

A call for a 24-year-old paper on Paxil to be retracted

More than two decades after a study claimed Paxil was safe and effective for adolescents, the Journal of the American Academy of Child & Adolescent Psychiatry is reviewing whether to retract it amid fresh legal pressure. The 2001 paper, long criticized in part for downplaying suicidal risks, became central to a $3 billion Justice Department settlement with GSK and has since been cited nearly a thousand times.

Attorney George Murgatroyd, representing families of children who died by suicide after taking the drug, argues the article remains a dangerous "promotional piece masquerading as science." At least one researcher who has followed the saga said a retraction is overdue, warning the flawed study continues to shape clinical guidelines despite evidence Paxil is neither safe nor effective in teens.