Phase III
CSL’s investigational cholesterol efflux enhancer CSL112 failed to reduce major adverse cardiovascular events within 90 days in patients who had just suffered a heart attack.
Madrigal Pharmaceuticals announced late-stage results published Thursday in The New England Journal of Medicine for resmetirom as it awaits a March 14 PDUFA date.
Gilead Sciences is ending the development of magrolimab for the treatment of blood cancer following the FDA’s placement of a clinical hold on all its programs related to the drug.
Under the FDA’s compassionate use program, an eyedrop formulation of Krystal Biotech’s Vyjuvek restored the vision of a teenager with the rare genetic disease dystrophic epidermolysis bullosa.
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.
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