European Pharmaceutical Review

JULY 29, 2024

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.

Generic Medicine 52

Generic Medicine Biosimilars 52

European Pharmaceutical Review

APRIL 30, 2024

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.

Biosimilars 98

Biosimilars Generic Medicine Chemotherapy Hospitals 98

European Pharmaceutical Review

JULY 1, 2024

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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Generic Medicine Vaccines Biosimilars 106

European Pharmaceutical Review

FEBRUARY 26, 2024

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.

Generic Medicine 98

Generic Medicine Vaccines Pharmaceutical Companies Pharmaceutical Companies 98

Express Pharma

MARCH 3, 2025

According to him, Passing the PILLS Act is a necessary first step to reverse this trend, restore American pharmaceutical production, create high-quality jobs, and protect national security by ensuring a safe, reliable domestic supply of high-quality generic medicines, antibiotics, and other essential drugs.” Sounds familiar?

Generic Medicine 94

Generic Medicine Biosimilars 94

European Pharmaceutical Review

FEBRUARY 3, 2025

Biosimilars given a positive opinion Dyrupeg (pegfilgrastim) to reduce the duration of neutropenia and help prevent febrile neutropenia following chemotherapy. The EC questioned whether this would necessitate an update of the CHMPs opinion made in November 2024.

Generic Medicine 52

Generic Medicine Vaccines Chemotherapy Biosimilars 52