Drug Development
Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.
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The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
Recent breakthroughs and three decades of progress in treating Huntington’s disease
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Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.
AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label.
The checkpoint inhibitor is approved for several cancers in China, but after an indefinite FDA delay last summer, BeiGene’s partner Novartis still awaits its first U.S. approval.
The leaked data show that Carvykti cuts the risk of disease relapse by 74% versus standard chemotherapy regimens.
Lilly investigators said they hoped to differentiate their Phase I candidate from the competitive KRAS space by making it the first to gain approval as a first-line treatment.
The checkpoint inhibitor improved patient outcomes in three cancer trials, according to results presented at the AACR meeting.
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
Roche, AstraZeneca, Moderna, Merck and Affimed presented new data in liver cancer, lung cancer, melanoma and lymphoma.