United Therapeutics' pulmonary arterial hypertension therapy Remodulin (treprostinil) clears FDA May 21 via accelerated approval. The company's Phase IV confirmatory study will assess safety and efficacy of the drug in approximately 100 PAH patients who were stable on GlaxoSmithKline's Flolan (epoprostenol). Subjects will be withdrawn from Flolan and randomized to Remodulin or placebo for eight weeks. Remodulin is indicated for use in PAH "patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise." The drug is given as a continuous subcutaneous infusion via a portable infusion pump, while Flolan, indicated for PAH patients with NYHA Class III and IV symptoms, requires intravenous administration through a central venous cathete
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
