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EMA human medicines committee (CHMP) highlights, November 2022

European Pharmaceutical Review

Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine. Read highlights from the CHMP’s September 2022 meeting.

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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. Teriparatide SUN (teriparatide) for the treatment of osteoporosis in adults. Safety update.

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Sandoz to become standalone company

European Pharmaceutical Review

Novartis has announced that it intends to separate Sandoz , its generics and biosimilars division into a new publicly traded standalone company. The 100 percent spin-off aims to establish Sandoz as the premier European generics company and a global leader in biosimilars, maximising shareholder value.

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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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Waters, as a strategic partner to the pharma industry, can help India become a world leader in biosimilars

Express Pharma

For decades, Waters has been a trusted partner to many pharma and generics companies operating in India, particularly for small molecule QA/QC. India is known as the ‘Pharmacy of the World’, as the generic medicine supplier for over 200 countries, both developed and emerging markets. How poised are you to leverage them?

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Sandoz bulks up ahead of possible sale with Coalesce buy

pharmaphorum

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.

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CHMP meeting highlights – March 2023

European Pharmaceutical Review

The CHMP adopted a positive opinion for Epysqli (eculizumab), a biosimilar medicine for paroxysmal nocturnal haemoglobinuria. CHMP’s January 2023 meeting highlights… Read the EMA’s human medicines highlights 2022 report. It is a rare disorder that results in premature destruction and impaired production of blood cells.