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{ Category Archives: } Biotech (General)

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….

Novartis’ blockbuster heart med Entresto snags FDA approval in larger patient group

Novartis’ heart failure drug Entresto has been on the ascent after a slower-than-expected debut on the market, and now the drug has an expanded FDA label that could widen its reach to millions of new patients. The FDA on Tuesday endorsed Entresto—which already carried an OK in patients with chronic heart failure and reduced ejection fraction (HFrEF)—in heart failure with…

Horizon inks $3B deal to buy AstraZeneca spinout Viela for autoimmune drugs

Horizon Therapeutics has struck a $3 billion deal to buy AstraZeneca spinout Viela Bio. The takeover will give Horizon a clutch of clinical-phase autoimmune and inflammatory disease drug candidates, R&D capabilities and an approved monoclonal antibody. Viela spun out of AstraZeneca with six drug candidates and $250 million early in 2018. Since then, the biotech has gone…

Vir stock soars on blinded, 8-subject hepatitis B analysis

Shares in Vir Biotechnology rose 74% on the strength of data from a blinded, eight-subject cohort in its phase 1 hepatitis B trial. The analysis suggests the neutralizing monoclonal antibody may be more potent than expected and provides a boost to Vir’s prospects of delivering a functional cure. Investigators enrolled eight patients with chronic hepatitis B virus…