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. […]

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 […]

REGENERON’S ANTIBODY COCKTAIL REGN-EB3 (INMAZEB®) IS FIRST FDA-APPROVED TREATMENT FOR EBOLA (ZAIRE EBOLAVIRUS)

In a large clinical trial, Inmazeb showed superiority compared to other investigational agents (ZMapp and remdesivir) with respect to mortality; treatment was most effective when given early in the course of disease1 Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) is a novel anti-viral antibody medicine developed using the same ‘rapid response’ technologies as Regeneron’s investigational COVID-19 antibody […]

Japan Grants Patent to Brainstorm Covering Technique for NurOwn

The Japan Patent Office has granted a patent to Brainstorm Cell Therapeutics covering the proprietary technique that generates the company’s cell-based therapy NurOwn from mesenchymal stem cells (MSCs). Through this technique, researchers can harness MSCs directly from a patient and mature them into cells that produce high levels of neurotrophic factors, which are compounds that […]

Bausch Health Announces Its Intention To Spin Off Its Eye Health Business Into An Independent Publicly Traded Company

LAVAL, QC, Aug. 6, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”) today announced that it intends to spin off its leading eye health business into an independent publicly traded entity (“Bausch + Lomb – NewCo”) from the remainder of Bausch Health (“BHC”). The spinoff will establish two separate […]