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What’s in Today’s Brief? (July 25th Preview)
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EU orphan-drug guidance and regulatory pushback
The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued two notable decisions on orphan drugs, backing Minoryx’s cALD therapy while rejecting a separate proposal for Niemann-Pick disease type C. In a process that included multiple positive opinions, Minoryx’s cALD program won CHMP support after prior regulatory hurdles.
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FDA peptide compounding debate accelerates access
An FDA advisory panel narrowly recommended allowing compounding pharmacies to manufacture some unapproved peptides, setting up a pivotal next step for the agency’s final decision. Panelists supported epitalon while recommending against compounding emideltide, following Thursday’s discussion on additional peptides that would expand access.
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EU rejects arimoclomol for NPC despite US approval
Zevra Therapeutics’ Niemann-Pick disease type C strategy took another hit in Europe as the EMA CHMP adopted a negative opinion on arimoclomol. The decision came after the CHMP concluded efficacy for the MAA was not sufficiently demonstrated.
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Sanofi abruptly ends atopic dermatitis filings for amlitelimab
Sanofi said it will not seek approval of amlitelimab in atopic dermatitis, citing the OX40-ligand antibody’s lack of meaningful improvement versus standard of care. The move reverses earlier expectations that amlitelimab could succeed as a next major franchise following Regeneron’s Dupixent.
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CAR-T toxicity genomics flags emerge from Yescarta trials
A new analysis using data from Kite Pharma’s Zuma-1 and Zuma-7 trials linked patient genetics to CAR-T toxicity risk in Yescarta (axi-cel). Published in Science Immunology, the study highlighted mutations in STXBP2 in Zuma-1 patients that corresponded with toxicity after treatment.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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