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CHMP meeting highlights – July 2024
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
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plaque psoriasis (PsO)
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J&J reveal long-term data for novel oral peptide
The new data suggests the IL-23 receptor antagonist peptide has potential to address the high unmet need of a durable and convenient oral option in moderate-to-severe plaque psoriasis.
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Sandoz to commercialise mAb biosimilar candidate
A new commercialisation agreement between Sandoz and Samsung Bioepis’ for its ustekinumab biosimilar candidate, means Sandoz now has five potential high-value biosimilars anticipated to launch over the next two years.
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Novel oral therapy shows potential in plaque psoriasis
"Development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm” in moderate-to-severe plaque psoriasis (PsO), stated a Janssen R&D VP.
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First-in-class plaque psoriasis oral therapy approved in EU
Bristol Myers Squibb’s Sotyktu is the only TYK2 inhibitor approved for the treatment of any disease in the European Union.
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First biosimilar to HUMIRA® available in US
AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.
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Citrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
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CHMP meeting highlights – January 2023
Four new medicines were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s January meeting, with positive opinions given to two type 2 diabetes drugs.
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Potential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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Early efficacy of arthritis therapy predicts long-term benefits
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
