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CHMP meeting highlights – December 2022

European Pharmaceutical Review

A generic medicine, Diethyl fumarate Accord (dimethyl fumarate), received a positive opinion for the treatment of multiple sclerosis (MS), a chronic disease affecting the central nervous system. EMA human medicines committee (CHMP) highlights, November 2022.

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EMA human medicines committee (CHMP) highlights, September 2022

European Pharmaceutical Review

Biosimilar medicine Ximluci (ranibizumab) for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease, causing gradual vision impairment, mainly in the elderly population. The post EMA human medicines committee (CHMP) highlights, September 2022 appeared first on European Pharmaceutical Review.

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EMA human medicines committee (CHMP) highlights, November 2022

European Pharmaceutical Review

New generic medicine Pirfenidone Viatris (pirfenidone), received a positive opinion to treat idiopathic pulmonary fibrosis (IPF), a chronic and progressive condition where the lungs become scarred and breathing becomes increasingly difficult. Read highlights from the CHMP’s September 2022 meeting.

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Reuters Pharma 2022 – a day one overview – part 1

pharmaphorum

The Reuters Pharma event 2022 began as a bustling industry affair yesterday, based out of the Nice Acropolis convention centre on France’s balmy south coast. Indeed, of the 281 WHO-listed essential medicines, 100% of respiratory treatments are Teva’s. NB: Part 2 of ’Reuters Pharma 2022 – a day one overview’ will follow shortly….

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Inflation threatens supply of life-saving generics to Europe

Pharmaceutical Technology

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

In the judgment ‘Pharmacia & Upjohn SA vs Paranova A/S’ (CJEU judgment of 12 October 1999 in case C-379/97) 2 CJEU decided that BMS conditions apply also to the medicinal product rebranding. Four recent rulings on parallel imports In November 2022, the CJEU announced four rulings on the parallel import of medicinal products.

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Sandoz bulks up ahead of possible sale with Coalesce buy

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For Sandoz, the acquisition gives it a technology platform in an area of the generic medicines market with a relatively high barrier to entry, as developing inhaled medicines poses “comparatively high technical complexity,” according to Sandoz chief executive Richard Saynor.