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.
FEATURED STORIES
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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Sanofi is discontinuing its Phase III study of tolebrutinib, an investigational BTK inhibitor for myasthenia gravis.
Keytruda could be on its way to snagging another indication as a first-line therapy for endometrial cancer after the company announced positive Phase III results Friday.
Roche is dropping its investigational AKT inhibitor ipatasertib, which was being assessed in a Phase III trial for castration-resistant prostate cancer, as well as several other candidates.
Novartis is cleaning house, cutting its Huntington’s disease program along with several others. The company announced multiple program stops and delays in its full-year 2022 report Wednesday.
The FDA asked Taysha Gene Therapies to dose more patients in a double-blinded, placebo-controlled trial before submitting a BLA for its giant axonal neuropathy candidate.
uniQure inked a deal with Apic Bio to gain development and commercialization rights to APB-102, a gene therapy for a rare, genetic form of ALS.
Vera Therapeutics released a 36-week per-protocol analysis of the Phase IIb trial assessing atacicept in IgA nephropathy.
Novartis’ SCD therapeutic Adakveo is under review by the EMA after failing to replicate previous efficacy results in a Phase III trial.
The FDA granted Eli Lilly’s Jaypirca accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma.
XyloCor Therapeutics reported positive topline results Thursday from Phase II of the Phase I/II trial of its gene therapy for refractory angina.