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CHMP meeting highlights: April 2024

European Pharmaceutical Review

CHMP biosimilar recommendations A positive opinion for Tofidence (tocilizumab) was adopted by the committee, indicated for rheumatoid arthritis, COVID-19, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. This covers paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.

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CHMP meeting highlights – June 2024

European Pharmaceutical Review

The committee gave a positive opinion for the biosimilar Steqeyma (ustekinumab). Additionally, approval was recommended two generic medicines: Enzalutamide Viatris (enzalutamide) to treat prostate cancer, and Nilotinib Accord (nilotinib) was also recommended to treat Philadelphia chromosome positive chronic myelogenous leukaemia.

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CHMP meeting highlights: February 2024

European Pharmaceutical Review

At its February 2024 meeting, the EMA’s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines. These products were designated as an orphan medicine during their development.

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CHMP meeting highlights – July 2024

European Pharmaceutical Review

Subject to regulatory approval by the European Commission, Yuvanci ® would be the only single tablet combination therapy in Europe for pulmonary arterial hypertension, Johnson & Johnson Innovative Medicine shared. The post CHMP meeting highlights – July 2024 appeared first on European Pharmaceutical Review.

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Indian pharma industry in 21st century – What has changed for domestic supply?

Express Pharma

We are basking in the glory of NDAs, ANDAs, new molecules, biosimilars, and technological advances coupled with quality optimisation and training at the global level at par with Europe, the US, and Japan, doubling and trebling international trade in the next five years.

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Regulatory convergence is extremely important

Express Pharma

IGBA is the International Generic and Biosimilar Medicines Association. The association is formally set up in Switzerland, and it’s the trade association gathering the associations of generic and biosimilar medicines across the world. What is IGBA’s mandate? The products are getting more complex.