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CSL is advancing clazakizumab for the treatment of cardiovascular events in end-stage kidney disease and will retain rights over the asset in this indication. Lilly will explore other conditions.
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An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer.
Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the agency emphasized that using this technology is optional for its employees.
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
U.K.-based pharmas will not face tariffs as long as Donald Trump is president, according to the agreement.
Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug purchased through LillyDirect. Both pharmas recently struck a deal with the White House for cheaper prices via the yet-to-be-launched TrumpRx.
Protego Biopharma is advancing a small-molecule drug that helps light chain proteins fold correctly, in turn addressing the underlying biological cause of AL amyloidosis.
The centerpiece of the deal is the in vivo editor TSRA-196, which in preclinical studies has shown robust editing at SERPINA1, the locus linked to alpha-1 antitrypsin deficiency.
The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.
If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.
As bispecifics, ADCs, protein degraders, and AI-designed mini-proteins move into the clinic, discovery teams face a new bottleneck: engineering and producing molecules whose complexity challenges conventional workflows.