Spectrum Pharmaceuticals Inc. stressed its ability to offer access to its novel long-acting granulocyte colony stimulating factor (G-CSF) Rolontis, through patient assistance programs, based on positive data from two Phase III studies – ADVANCE and RECOVER – that pave the way for a biologic license application (BLA) filing in the fourth quarter.
Spectrum Gears Up To File Rolontis, Stresses Patient Access
Biosimilars of Amgen's blockbuster Neulasta pose a competitive threat to long-acting GSF Rolontis, but the company has experience with group purchasing and notes that large oncology clinics will make more revenue by providing higher-priced products.
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Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
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Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.
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By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
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AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.