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With the FDA’s approval, Fasenra will compete with GSK’s Nucala, which in December 2017 became the first biologic approved for eosinophilic granulomatosis with polyangiitis.
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The release of early-stage data on three oral weight loss drug candidates hints at which companies have the strongest hand, but the comparisons are rife with confounding variables, leaving analysts unsure about where to place their bets.
Last month, Vertex said sickle cell patients had not yet received infusions of its gene therapy Casgevy. That’s now changed, as the company races with bluebird bio’s Lyfgenia.
Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia.
From Our News Editor
Every week, BioSpace’s Greg Slabodkin offers his take on the biggest stories happening in our industry.
It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.
THE LATEST
The mesothelioma approval for the Keytruda combination regimen potentially unlocks a $12 billion market opportunity, according to a recent report from research firm IMARC Group.
Ahead of a Senate health committee hearing next week with Novo Nordisk CEO Lars Jørgensen, Sen. Bernie Sanders claims he has secured assurances from generics developers that they will charge a significantly lower monthly price than the $969 Americans currently pay for the Danish drugmaker’s diabetes blockbuster.
The FDA’s approval of Kisqali in combination with an aromatase inhibitor allows Novartis to target patients with earlier breast cancer who are at risk of recurrence.
If Johnson & Johnson refuses to scrap its proposed changes to the 340B drug pricing for hospitals, it risks the termination of participation in the program and monetary fines, the Health Resources and Services Administration warned.
Infusions of Vertex and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia have begun; Moderna targets 10 approvals through 2027; more oral obesity drug data; the latest from ESMO and more.
Pharmacy benefit manager Express Scripts announced Tuesday it has filed a lawsuit in federal court in Missouri against the Federal Trade Commission for its “unfair, biased and erroneous” July report on the industry.
Despite meeting the primary endpoint in a Phase III study, two patients treated with Merck and Daiichi Sankyo’s experimental antibody-drug conjugate died in a Phase III non-small cell lung cancer study, though the deaths have not been linked to patritumab deruxtecan.
In metabolic dysfunction-associated steatotic liver disease, a retrospective analysis shows that patients on GLP-1 receptor agonists are 14% less likely to progress to cirrhosis.
Boehringer Ingelheim’s investigational compound nerandomilast, which targets the PDE4B enzyme involved in fibrosis and inflammation in the lungs, met its primary endpoint in a late-stage study.
The newly approved filling line will be able to provide both 50-mg and 100-mg doses of the respiratory syncytial virus antibody Beyfortus to help meet demand ahead of the 2024/2025 RSV season.