On the cusp of US approval, Amarin must wait until late 2020 for EMA judgement
Amarin’s blockbuster-in-waiting cardiovascular treatment Vascepa is on the path to EU approval with a filing at the European Medicines Agency.
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Chief medical officer Eliav Barr, responsible for overseeing clinical development, talked to Scrip in an interview at Merck’s headquarters about the company’s pipeline diversification.
Over the past few months, Chinese developers of CNS and cardiometabolic therapies have attracted the interest of domestic investors, amid generally modest funding activity.
The agency loosened requirements for echocardiograms and removed contraindications for a number of commonly used drugs.
BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.
Abeona plans to offer an outcomes-based payment model for Zevaskyn, which likely will see complementary use with Krystal’s Vyjuvek in recessive dystrophic epidermolysis bullosa patients.
The AKT inhibitor proves ineffective for metastatic castration-resistant disease in a Phase III trial.
The companies will co-develop the drug for additional indications beyond Huntington’s disease, while Prilenia retains rights in key global markets.
