FDA's warning about 19 deaths related to excessive, off-label dosing for Ocaliva in primary biliary cholangitis spurs fears doctors will curtail prescribing and, worse, that the larger upcoming NASH market opportunity may be affected.
AnFDA warning about serious liver injury and 19 deaths related to excessive dosing of Intercept Pharmaceuticals Inc.'s Ocaliva in patients with primary biliary cholangitis, a rare liver disease, has raised fears about loss of sales in the short term and opportunity longer-term in the greater market opportunity of nonalcoholic steatohepatitis.
In a safety communication on Sept. 21, FDA warned that there was a problem with excessive dosing of PBC patients,...
The CEO of South Korean biotech shares how his company was able to reach a partnership with Rani so quickly and why it is confident in its GLP-1/GLP-2 dual agonist for obesity and diabetes, despite recent disappointing clinical results for its sole rival.
Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
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
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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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