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{ Category Archives: } Biotech (General)

Amazon kicks off new role as diagnostics provider by making COVID test available online

Amazon has already changed the way we shop and filled our homes with “smart” gadgets, and now, the tech giant is looking to change the way we manage our health, both in the face of a pandemic and beyond. Amid the launch of its own wellness-tracking smartwatch and the expansion of the Amazon Care telehealth service,…

Provention Bio brought back down to earth as FDA panel narrowly backs diabetes prevention drug

Provention was flying high on Tuesday when an FDA advisory panel seemed to back the efficacy of its diabetes prevention drug, even after the agency flagged some issues with the data package supporting the therapy’s application a month earlier. But the company is not out of the woods yet, with the final vote only narrowly…

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…

Lilly’s phase 2 Alzheimer’s win marred by missed secondaries, questions about clinical significance

Eli Lilly has shared full data from a phase 2 clinical trial it hailed as showing a “significant slowing of decline” in Alzheimer’s disease patients. The donanemab data are a mixed bag, with a slight win on one disease scale undermined by a failure on a more widely used measure of Alzheimer’s. In January, Lilly…

Donanemab in Early Alzheimer’s Disease

Abstract BACKGROUND A hallmark of Alzheimer’s disease is the accumulation of amyloid-β (Aβ) peptide. Donanemab, an antibody that targets a modified form of deposited Aβ, is being investigated for the treatment of early Alzheimer’s disease…. … RESULTS A total of 257 patients were enrolled; 131 were assigned to receive donanemab and 126 to receive placebo….

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…

Takeda takes full control of drug for rare epilepsies

Takeda, the world’s largest developer of rare disease drugs, said Tuesday that it has reclaimed full rights to an experimental medicine being tested against uncommon forms of epilepsy. The deal inked with New York-based Ovid Therapeutics carries an almost $200 million upfront payment and could be worth as much as $856 million provided the medicine,…

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….