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Canan Schuman, PharmD/PhD
Posts
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...
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...
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...
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...
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...
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...
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...
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...
Canopy Growth Sues GW Pharma for Using Their Patent
Most of us immediately think of cannabis oil when we see the CBD- and THC-rich super sticky sludge usually found in vaporizer cartridges. Yet, do...
DECENTRALIZED TRIALS & RESEARCH ALLIANCE (DTRA) LAUNCHES TO DEMOCRATIZE AND ACCELERATE CLINICAL TRIALS
December 10, 2020 – An historic alliance of life sciences and healthcare organizations seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research....