High-Stakes Meeting With EMA On The Cards For Oncopeptides’ Pepaxto
Executive Summary
Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.
You may also be interested in...
High-Stake Meetings With EMA In Store For Sponsors Of EU Filings
The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA
After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.
BMS & Pfizer Win Funding ‘Firsts’ In England For Migraine & Heart Disease Drugs
Bristol Myers Squibb and Pfizer both asked the health technology assessment body NICE to evaluate their respective drugs, Camzyos and Vydura, for use in indications that are narrower than those for which they are – or will potentially be – approved.