The Stakes Are High So Get It Right
CHMP Oral Explanations And FDA AdComs
The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. Consultant Kate Dion highlights to In Vivo helpful tips for companies facing this daunting situation.
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The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
The reimbursement deal will allow cystic fibrosis patients as young as two years of age to access Orkambi in France for the first time.
Bristol-Myers Squibb’s newly acquired company Celgene is one of two drug sponsors that this month made it onto the European Medicines Agency’s priority medicines scheme. The other is Achillion Pharmaceuticals, which is developing a treatment for paroxysmal nocturnal hemoglobinuria.