Drug Development
Safety and dosing are likely to be “key differentiators” for Arrowhead Pharmaceuticals as it looks to challenge Ionis Pharmaceuticals’ lead in the severe hypertriglyceridemia market.
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Biopharmas developing CAR T therapies for autoimmune indications face major barriers to maximizing the market. Advances in the provider ecosystem and clinical infrastructure, as well as access and education, will be key to launching at scale.
Current leaders Eli Lilly and Novo Nordisk have cornered the early market for weight loss therapeutics, but several other players, large and small, are bidding for a piece of the potential $200 billion pie.
Twenty-five biotechs have used the IPO route to go public this year—with five of those debuts occurring this month alone. It’s the most IPOs since 2021, when the industry recorded 78 during the height of the COVID-19 pandemic.
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Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
AstraZeneca and Amgen co-develop and co-commercialize Tezspire under an April 2012 agreement. The partners are now planning another FDA submission for the asthma drug, which received an expansion into chronic rhinosinusitis last year.
In this episode of Denatured, you’ll hear from Hilary Rosselot, executive director at the National Fragile X Foundation and Jordi Fàbrega, co-founder & CEO at CONNECTA Therapeutics. From trial endpoints and placebo effects to neuroplasticity modulation, we explore what it will take to build a sustainable path to the first approved therapy.
The FDA granted the approval of Revolution Medicines’ daraxonrasib, now to be known as Rasonque, in pancreatic adenocarcinoma 6.5 months ahead of deadline.
The Phase 3 readout is the first for ivonescimab beyond non-small cell lung cancer to show a significant overall survival benefit, according to Summit Therapeutics and China-based partner Akeso.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.
While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.
While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient.
The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new target action date for the therapy is November 22.