NGM’s closely-watched NASH prospect flops, cutting shares in half and spurring R&D rethink

A phase 2b trial of NGM Biopharmaceuticals’ aldafermin in nonalcoholic steatohepatitis (NASH) has missed its primary endpoint, sending shares in the biotech tumbling. NGM has pulled plans to enter phase 3 in light of the midstage failure of the FGF19 analog. California-based NGM ramped up expectations for aldafermin last year when it delivered midphase data linking […]

Russia’s Sputnik V nabs first Twitter-verified vaccine handle, but is it PR or propaganda?

A blue check for Sputnik V—and a cautionary marketing tale for the pharma industry? The Russian-developed coronavirus vaccine nabbed verified status from Twitter last week, doubling down on its broadcasting wave of tweets, retweets and plenty of American-style attitude. But is the now-authenticated social media account a pharma influencer case study or a cautionary tale of disinformation? While […]

Woman of the Week: A 2020 Anthology

A full-year of amazing women leaders — 53 unique career journeys and 53 lessons in courage, perseverance, and strength. This e-publication features healthcare and life-science industry executives and their stories of leadership, lessons learned, and wow moments. Each profile includes a link to the original WoW podcast and full manuscript. In honor of International Women’s […]

Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus

STAMFORD, Conn, and ST. GALLEN, Switzerland, March 08, 2021 (GLOBE NEWSWIRE) — Cara Therapeutics (Nasdaq:CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The […]

FDA APPROVES FIRST-IN-CLASS EVKEEZA™ (EVINACUMAB-DGNB) FOR PATIENTS WITH ULTRA-RARE INHERITED FORM OF HIGH CHOLESTEROL

Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C) In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 weeks, compared to placebo Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. […]