Track topics on Twitter Track topics that are important to you
Newron Pharmaceuticals S.p.A. (SIX:NWRN) re-submitted an NDA to FDA for Parkinson's disease candidate Xadago safinamide. In March, FDA issued a complete response letter for Xadago as an add-on therapy for early and mid to late stage PD in patients who are inadequately managed on their current treatments (see BioCentury Extra, March 29).
Newron said last month that FDA will not require it to conduct clinical studies of Xadago's dependence and withdrawal effects or abuse liability. Xadago is an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B (MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity.
Newron gained CHF1 to CHF22.90 on Thursday.
Original Article: Newron re-submits Xadago NDANEXT ARTICLE
Parkinson's is a progressive neurological condition, affecting one person in every 500, 95% of which are over 40. It is caused by degeneration of more than 70% of the substantia nigra, which depletes the dopamine (the neurotransmitter involved in pro...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...