EMA
In Brief This Week: Eisai, Biogen, Carsgen, VolitionRx, Ocugen, Regenxbio, Guardant Health, Avacta
News items for the week of March 3, 2025.
EC Resumes Review of Eisai, Biogen's Leqembi Application After CHMP Reaffirms Positive Opinion
The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.
CHMP Recommends Approval of Krystal Biotech's Gene Therapy Vyjuvek for Wound Skin Condition
Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.
Fondazione Telethon Seeking Approval for Wiskott-Aldrich Syndrome Gene Therapy in Europe
Thirty patients have received the gene therapy within a clinical trial and early-access program, and the foundation also hopes to seek approval in the US.
CHMP Recommends Approval of J&J's Subcutaneous Rybrevant for Certain NSCLC Patients in Europe
The committee recommended the new formulation in two EGFR-mutated advanced NSCLC settings, for which intravenous Rybrevant is already available.