The FDA on 3 July surprised Spectrum Pharmaceuticals and its partner Topotarget – which is finalizing a merger with BioAlliance to form Onxeo – by granting approval of Beleodaq (belinostat) more than a month ahead of schedule as a treatment for patients with peripheral T-cell lymphoma (PTCL), a diverse group of rare and aggressive diseases, which account for up to 15% of all non-Hodgkin lymphomas.
The FDA on 3 July surprised Spectrum Pharmaceuticals and its partner Topotarget – which is finalizing a merger with BioAlliance to form Onxeo – by granting approval of Beleodaq (belinostat) more than a month ahead of schedule as a treatment for patients with peripheral T-cell lymphoma (PTCL), a diverse group of rare and aggressive diseases, which account for up to 15% of all non-Hodgkin lymphomas.
Shares of Henderson, Nevada-based Spectrum jumped 6.3%, or 55 cents, in morning trading on 3 July.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
The IL-4/13 inhibitor was approved in the US for COPD, a blockbuster-sized indication, but the commercial ramp could take time and several competitors are on its heels.
As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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