FDA has requested additional data analyses on Pfizer's oral JAK1 inhibitor tofacitinib for rheumatoid arthritis, which will likely push back the agency’s review timeline beyond the August PDUFA date, management warns.
FDA leaves door open to modify label of Amarin’s omega-3 fatty acid therapy Vascepa prior to approval in a healthier population, says company CEO. Per the current label, triglycerides are lowered significantly with no increase in LDL cholesterol, a potential differentiating point from Pronova/Glaxo’s blockbuster EPA/DHA therapy Lovaza.
Merck reported strong 2Q earnings on July 27 but spent its conference call emphasizing the promise of its late-stage pipeline. The company expects to file six drugs for U.S. approval over the next 18 months.
Financings of the fortnight takes note of the rising fortunes for gene therapy, as represented by Bluebird Bio’s third significant venture round since 2010. Plus news on recent financing activity by Ailmera, Durata and CoDa Therapeutics.
Join CHI-California Healthcare Institute, in collaboration with Merrill DataSite, invite you to a complimentary, 75-minute webinar which will address the provisions of the Agency-industry negotiated agreement, potential additional and related provisions...
Amarin's Vascepa May Give Lovaza A Run For Its Money Label for Amarin's EPA-only omega-3 fatty acid therapy notes that in patients with really high triglycerides, triglycerides are lowered significantly with no increase in bad cholesterol, a potential differentiating point from Pronova/Glaxo's blockbuster EPA/DHA therapy Lovaza. But contrary to what Amarin wanted, data from a study in healthier patients doesn't make it into labeling.