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Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a draft reflection paper released for stakeholder comment.
Pfizer’s appeal for a second patent on Lyrica (pregabalin) has been denied by the UK’s highest court, ending the pharma giant’s long-running fight against drug companies marketing generic versions of its blockbuster pain treatment.