European Notebook: Pricing Mistrust Needs Open Debate; Rasi Nears EMA Return; Market Turmoil Affects IPOs
The EU’s Health Commissioner called for an open debate on pharmaceutical pricing with industry, while Guido Rasi prepares for part two of helming the European Medicines Agency and German big pharmas Bayer and Merck KGaA completed business restructuring. More developments in this month's column.
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Acacia Pharma’s long-term aim, once its go-it-alone US strategy is in hand, is to turn its attention to ex-US partnering possibilities for its lead product for post-operative nausea and vomiting. It will also develop a Phase II candidate for chemotherapy-induced nausea and vomiting.
European Notebook: All Change In The C-Suites; EMA PRIME Starts; French Experts Recommend Phase I Changes
Once-in-a-decade leadership changes stack up in Europe’s big pharma companies as the region aims for quicker and more certain drug development, although following a recent fatality an expert committee is advising caution during dose-escalation in Phase I studies.
European Notebook: Clinical Trial Fatality; Affordable Medicines Debate; Physician Payment Disclosure
One death and five healthy volunteers hospitalized in a Phase I study in France; EU Council looks set to debate patient access to medicines; and the two Mercks set to continue litigation in Europe and the US over use of the Merck word, straining their 60-year-old agreement. Generics/biosimilar trade group adopts physician payment disclosure policy.