Phase III
Hit with lower sales of its COVID-19 antiviral Veklury and the weak performance of its HIV franchise, Gilead Sciences reported a 4% year-over-year revenue loss in the fourth quarter of 2023.
The monoclonal antibody Nipocalimab, which J&J acquired from Momenta Therapeutics, met its primary endpoints in mid-stage and late-stage trials in myasthenia gravis and Sjögren’s disease.
The company’s three-drug combination met all primary and key secondary endpoints in two randomized controlled trials in cystic fibrosis patients, paving the way for an application to regulators.
The antibody-drug conjugate, in combination with Takeda’s Velcade and the steroid dexamethasone, reduced the risk of death and disease progression by 59% versus a similar Darzalex-based regimen.
With one disease-modifying therapy already reaching patients and another expected to soon, several biopharma companies anticipate key data for novel assets in the coming 12 months.
Positive Phase III results for VX-548 could signal a new chapter in the fight against opioid addiction, but experts say there is still room to do better.
The Swiss pharma’s fourth-quarter sales fell short of analysts’ estimates on Wednesday, as the company said it dropped a late-stage blood cancer hopeful after failing a Phase III study.
After VX-548 demonstrated significant pain relief in surgical and non-surgical settings, Vertex Pharmaceuticals is preparing to file a New Drug Application for the non-opioid candidate by mid-2024.
Bristol Myers Squibb’s PD-1 inhibitor was unable to outperform the placebo arm in improving disease-free survival in renal cell carcinoma patients at high risk of relapse after surgery.
The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.
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