New EU Filings Include First-Of-Its-Kind MS Drug Tolebrutinib & HIV Prophylaxis Lenacapavir

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.

Neurodegenerative disease concept 3d illustration
Tolebrutinib is an oral, brain-penetrant and bioactive BTK inhibitor for treating multiple sclerosis (Shutterstock)

Tolebrutinib, Sanofi’s investigational treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS), is among the latest products that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

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Newest HHS Staff Cuts Could Stymie CMS Health Plan Oversight

 
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.

Oncology Center Of Excellence Deputy Directors Kluetz, Theoret Join US FDA Exodus

 

The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.

Pink Sheet Podcast: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

 

Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.