GlaxoSmithKline will continue to defend itself against all claims alleging ranitidine increased the risk of cancer. Four generic firms reach settlements in the first case that had been scheduled for trial. GSK, Sanofi and Pfizer could pay $1bn-$2bn each in potential settlements, an analyst predicts.
The settlements by four generic manufacturers in a single Zantac (ranitidine) product liability case gives some sense of what global resolutions might entail. However, brand companies may opt to go to trial rather than settle, as GlaxoSmithKline plc has indicated.
The first trial in the Zantac litigation had been scheduled to begin 22 August in Illinois state court. Counsel for...
The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
