Cladribine is back in the running to be the first oral multiple sclerosis therapy to market. EMD Serono, the U.S. affiliate of Merck KGaA, announced that FDA has accepted a refiling of the NDA it rejected in Novmeber and given it a priority six-month review with an action date in the fourth quarter. Competitor Biogen Idec's candidate Gilena has an action date in September.
Astellas Pharma has extended its non-exclusive license agreement under which it uses Regeneron’s Velocimmune technology platform to discover fully human monoclonal antibody candidates. Under the revised deal, Astellas will pay $165 million upfront to extend the license through 2018 and then, if it does not terminate the deal, will pay another $130 million in 2018 to extend the agreement through 2023.
FDA’s Cardiovascular and Renal Drugs Advisory Committee weighs whether use of high-dose aspirin caused AstraZeneca’s antiplatelet drug Brilinta to appear ineffective in U.S. patient population.
The UK is behind other countries in its use of innovative cancer drugs and the government says it is determined to change this. The pharmaceutical industry says the UK prices are amongst the lowest in Europe and that it will work with the government to make cancer drugs more readily available.
