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EC approves argenx’s efgartigimod alfa for CIDP treatment

Pharmaceutical Technology

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years. The 505(j) pathway is how you get a multisource generic.

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DoH – Abu Dhabi and Sanofi link for vaccine development

Pharmaceutical Technology

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CNS innovator oligonucleotide licensing value up 339% from £2bn in 2024

Pharmaceutical Technology

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Harbour BioMed partners Otsuka on new T-cell therapy

Pharmaceutical Technology

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Madrigal poised to enter European MASH market after CHMP endorsement

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Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

Pharmaceutical Technology

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