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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD. The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases.

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Major manufacturing investment to support API production for tirzepatide

European Pharmaceutical Review

billion investment for Eli Lilly and Company ’s manufacturing site in Lebanon, Indiana, US, increases the firm’s total investment there from $3.7 This expansion will expand manufacturing capacity of active pharmaceutical ingredients (APIs) for Zepbound ® (tirzepatide) injection and Mounjaro ® (tirzepatide) injection. This new $5.3

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World-first medicine manufacturing regulatory framework to be implemented

European Pharmaceutical Review

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). Products manufactured at the point of care are eligible for the MHRA ILAP pathway.

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Continuous manufacturing: an evolving technology for drug substance manufacturing

European Pharmaceutical Review

1 There are several reasons why the adoption of continuous manufacturing (CM) for drugs lagged applications elsewhere. 1 There are several reasons why the adoption of continuous manufacturing (CM) for drugs lagged applications elsewhere.

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WuXi Biologics achieves large-scale manufacturing milestone

European Pharmaceutical Review

A combination of four 4,000-litre single-use bioreactors reaching a 16,000-litre scale has resulted in the successful completion of WuXi Biologics’ first manufacturing run at its drug substance facility MFG7 in Ireland. “We are excited to achieve this milestone for the Ireland facility.

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AI startup Leucine raises $7m for drug manufacturing digital twin platform

Pharmaceutical Technology

As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.

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Regeneron's high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

Fierce Pharma

But the company said it has nothing to do with the drug's efficacy or safety. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter.

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