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EMA Thumbs Up For HyQvia As Maintenance Therapy For Rare Neurological Disorder

 
• By Vibha Sharma

The European Medicines Agency has recommended in favor of allowing new uses of four already-approved drugs and suspending the marketing authorization of several generics tested by an Indian-based CRO. 

Businessman showing thumbs up - closeup shot
Four EU Medicines Are On Track For Labeling Changes Following Positive CHMP Opinions • Source: Shutterstock

Takeda/Baxalta Innovations’ immune globulin (IG) treatment HyQvia (human normal immunoglobulin) is on track to secure a new EU-wide indication as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

HyQvia is already approved in the EU as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial

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• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.