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EMA plans biomarker and drug-matched guidelines

The European Medicines Agency (EMA) is working on guidelines to help drug firms to develop companion diagnostics in parallel with medicines.

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ScinoPharm showcases water treatment tech at Baxdela API plant

ScinoPharm has emphasised its compliance with waste water treatment rules, weeks after being contracted to supply API for Melinta Therapeutics’ antibiotic Baxdela.

GSK opens API facility in Scotland

GlaxoSmithKline has officially opened its aluminium salts facility in Montrose, Scotland.

Germany refuses to renew GMP cert for Dr Reddy's Bachupally FTO 2 plant

German regulators have not renewed the GMP certificate for Dr Reddy’s manufacturing plant in Bachupally, Hyderabad.

EMA bids to clarify API starting material info pharmas should provide

The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.

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