The company filed an sNDA with the US FDA for the triple combination, hoping to expand its current COPD indication to also include asthma.
GlaxoSmithKline PLC is hoping to expand the use of the triple combination inhaler Trelegy Ellipta (fluticasone/umeclidinium/vilanterol) to asthma, announcing on 2 October that it has filed a supplemental new drug application with the US Food and Drug Administration for that indication. That would position a potential approval for the second half of 2020.
Trelegy, approved in the US for chronic obstructive pulmonary disease (COPD) since 2017, is one of GSK's growth drivers in...
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.
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
Discontinuation of the AML study created concern about potential readthrough to a pivotal MDS trial, but the company and analysts pointed out differences in the diseases.
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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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