Novartis malaria drug Coartem has expanded its approval to include babies. The combination drug, originally formulated as a tablet, has a new dose strength and formulation designed for treating newborns and young infants who develop malarial infections.
KalVista Pharmaceuticals’ Ekterly is now FDA approved for treating acute swelling attacks from hereditary angioedema. The KalVista tablet provides an alternative to injectable or infused HAE medications from companies such as Takeda Pharmaceutical and CSL Behring.
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Novartis’s Cosentyx failed to beat a placebo in a Phase 3 clinical trial in giant cell arteritis. The antibody drug was being developed as an alternative to Roche and AbbVie drugs whose approved uses include treating this autoimmune disorder affecting blood vessels.
Dizal Pharmaceutical’s Zegfrovy is now FDA approved for treating non-small cell lung cancer driven by a particular rare genetic signature. Johnson & Johnson drug Rybrevant already addresses this genetic signature as an earlier line of therapy, but Dizal executives contend their drug offers the potential for better safety and efficacy.
Organon said OG-6219 did not beat a placebo in a mid-stage clinical trial whose main goal was to measure the change in pelvic pain caused by endometriosis. The twice-daily pill came from Organon’s 2021 acquisition of Forendo Pharma.
Instead of an engineered peptide to activate gut receptors to trigger metabolic effects, Syntis’s technology forms a coating in intestines that has the effect of redirecting nutrients, mimicking an effect of gastric bypass surgery. In other obesity medicine news, Protagonist Therapeutics revealed a drug candidate that puts it in competition with Novo Nordisk and Eli Lilly, among others.
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AbbVie is acquiring Capstan Therapeutics, a startup with technology that enables in vivo engineering of immune cells. The University of Pennsylvania spinout’s lead program recently began a Phase 1 test as a potential treatment for B cell-mediated autoimmune disorders.
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Vor Bio is licensing global rights to a fusion protein that inhibits two targets to potentially treat the neuromuscular disorder generalized myasthenia gravis. It’s a pivot for Vor, which last month ceased its cancer R&D and announced it would explore strategic alternatives.
Novavax’s partnership with Sanofi allows the pharma giant to explore potential combinations of assets from both companies, and it’s a blueprint for the kinds of alliances the vaccine developer is pursuing. Rather than commercializing vaccines, Novavax aims to turn its research into business development deals, R&D executive Ruxandra Draghia-Akli said.
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Nektar Therapeutics’ biologic drug rezpegaldesleukin takes a new approach to atopic dermatitis, or eczema, stimulating proliferation of immune cells that tamp down excessive immune responses. The drug met the goals of a Phase 2b study, but analysts note that cross-trial measures show those results are short of the marks achieved by Dupixent, the top biologic for atopic dermatitis.
In Phase 1/2 results for 12 patients at least one year after receiving the cell therapy, zimislecel, Vertex Pharmaceuticals reported all participants achieved blood glucose in the target range and 10 of the 12 were free of exogenous insulin as of the data cutoff. Vertex expects to complete enrollment in the pivotal portion of the study this summer, paving the way for potential regulatory submissions next year.
Draig Therapeutics’ lead drug is designed to safely target the AMPA receptor as a way of mediating the interplay between two neurotransmitters whose imbalance is associated with mood disorders. The startup is one of several that have recently raised mega rounds of financing to support programs in the clinic or entering clinical testing.
Gilead Sciences drug lenacapavir, brand name Yeztugo, is now approved for HIV pre-exposure prophylaxis. The twice injectable medication is hoped to improve uptake and adherence to PrEP.
Like the first death reported in March, Sarepta Therapeutics attributed the fatality to a case of acute liver failure following dosing of the Duchenne muscular dystrophy gene therapy, Elevidys. The company has proposed an immunosuppressive regimen to mitigate the liver injury risk posed by the therapy.