Shift toward intravenous abuse with the reformulated long-acting opioid, coupled with reports of a serious bleeding disorder and HIV transmission, spurred US FDA advisory committee to recommend regulatory action, which could include new labeling, strict risk management measures or market withdrawal.
Endo Pharmaceuticals Inc. faces the prospect that the US FDA will request withdrawal of, or require new labeling and a restrictive Risk Evaluation and Mitigation Strategy (REMS) for, Opana ER (oxymorphone extended-release) due to issues with intravenous abuse.
However, given the unique circumstances surrounding the re-evaluation of Opana ER’s safety, there is no indication that other long-acting opioids...
GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results
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.
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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