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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…

Eli Lilly’s COVID-19 antibody shows it can prevent the disease. But will doctors use it?

Eli Lilly’s bamlanivimab was the first antibody drug the FDA authorized to treat COVID-19. Now, the Indianapolis pharma has data showing the therapy prevents symptomatic infections. The catch? The data are limited to long-term care facilities, where vaccination is now underway—and despite their utility, antibody thereapies are having a tough time catching on. Bamlanivimab cut the…

Larry Goldstein, a well-known stem cell researcher at the University of California, San Diego who has received nearly $22 million in awards from the California stem cell agency, today was named to its governing board. It was the first time in the history of the 16-year-old agency that a scientist who has received agency awards has been appointed to the…

JPM: Regeneron execs say ‘it’s a problem’ how few COVID-19 patients are getting antibody treatments

To Regeneron, there’s no question about it: “We as a society have to do a much better job” of getting antibody therapies—such as the company’s own—to patients, R&D chief George Yancopoulos said Monday at the J.P. Morgan Healthcare Conference. Like Eli Lilly’s single-antibody treatment, Regeneron’s antibody cocktail bears an emergency use authorization in mild-to-moderate COVID-19 patients at…

How brain inflammation and healing is pointing to new glioblastoma targets

Canadian researchers have discovered that the healing process after a brain injury can give rise to the deadly brain tumor glioblastoma. By digging further to better understand that phenomenon, they’ve uncovered potential techniques for treating glioblastoma with precision medicine. Researchers from the University of Toronto, Hospital for Sick Children and the Princess Margaret Cancer Centre…

Issues at Italian CDMO leads to US approval delay for Novartis’ inclisiran

he US FDA has issued a complete response letter for Leqvio (inclisiran) due to ‘unresolved facility inspection-related conditions’ at a third-party site run by Corden Pharma. In October 2020, this publication reported the US approval of Novartis’ small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, Leqvio, was dependent…

Covid-19 roundup: Inovio enlists plasmid manufacturer to replace the one it’s in legal feud with; Cyberattacks spotted targeting vaccine distribution 

With its Phase II trial finally underway, Inovio has enlisted another key manufacturing partner to hit its goal of hundreds of millions of doses of its DNA vaccine — filling the role of a contract manufacturer it’s still in a legal standoff with. Japan’s Kaneka Eurogentec is tasked with plasmid production, for which Inovio has…