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If secured, AbbVie will add Apogee’s IL-23 blocker to its current immunology stalwarts Skyrizi and Rinvoq, which have helped the pharma ride out the steep patent cliff left behind from mega-blockbuster drug Humira.
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While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Eli Lilly, with a busier-than-ever business development team, has made a major vaccine play‚ months after hiring veteran vaccine regulator Peter Marks following his FDA departure.
Eli Lilly is the first pharma company to take first place in both categories in the eight years that intelligence firm IDEA Pharma has put out its analysis. Skyrocketing sales and multiple FDA approvals helped the company shoot to the top.
A single 1-mg/kg dose of Eli Lilly’s base editor can lower LDL cholesterol levels by 62% in patients with a heritable form of hypercholesterolemia. The pharma acquired the asset last year in the $1.3 billion Verve Therapeutics buy.
Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
Treatment with the TROP2 ADC sac-TMT led to a 70% objective response rate and progression-free survival was “significantly improved” as compared to placebo—the second positive readout for the asset this week.
Going private could give Recordati strategic flexibility and a stable source of capital, according to CVC Capital Partners and Groupe Bruxelles Lambert, which are offering to take the Italian pharma private for a 13% premium.
The agreement is the largest in a series of deals that Gilead Sciences has penned with Korea’s Yuhan.
Biogen and Denali’s Parkinson’s disease drug failed to significantly slow disease progression in a Phase 2b study, missing both primary and secondary endpoints.