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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After reporting promising interim findings from the Phase IIa INTEGRIS-IPF trial, Pliant Therapeutics commenced a public stock offering of $175 million.
Rhythm Pharmaceuticals published data Monday showing Imcivree (setmelanotide) improved quality of life for patients with obesity related to Bardet-Biedl Syndrome.
Phase III data showed Ipsen’s Onivyde boosted overall survival in metastatic pancreatic ductal adenocarcinoma.
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.
The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
Disc Medicine inked an exclusive license agreement with Mabwell Therapeutics for the latter’s portfolio of monoclonal antibodies against the TMPRSS6 protein.
Jazz Pharmaceuticals and Zymeworks announced results from a Phase II trial of the latter’s HER2-targeted antibody for metastatic gastroesophageal adenocarcinoma.
Roche’s Tecentriq (atezolizumab) combined with Avastin (bevacizumab) met the primary efficacy endpoint in early-stage hepatocellular carcinoma in the Phase III IMbrave050 study.
Johnson & Johnson discontinued the Phase III trial of an investigational HIV vaccine regimen Wednesday after an independent review showed it was ineffective at preventing disease.
The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.