Biomarkers have moved from “nice-to-have” to the backbone of drug development, says Quanterix’s Jorge Marques Signes, who argues they now shape feasibility, timelines and even payer expectations before sponsors commit thousands of patients or years of spend. “Biomarkers are not supplemental anymore,” said Marques Signes, VP of Accelerator & Clinical Services at Quanterix. “They are… The post Quanterix VP: Why biomarkers are no longer supplemental appeared first on Drug Discovery...| Drug Discovery and Development
Ken Paxton, the Republican attorney general of Texas, sued Kenvue, the manufacturer of Tylenol, on Tuesday, for “deceptively marketing Tylenol to pregnant mothers despite knowing that early exposure to acetaminophen leads to a significantly increased risk of autism and other disorders,” according to the press release. J&J illegally offloaded liability, Paxton claims Paxton also claimed… The post Texas sues Kenvue claiming it hid link between Tylenol and autism appeared first on Drug D...| Drug Discovery and Development
Following a White House press conference on Sept. 22, during which Donald Trump alleged a link between acetaminophen use during pregnancy and autism, the Informed Consent Network (ICAN) filed a petition with the FDA to add a warning to all drugs that contain acetaminophen. ICAN is a nonprofit organization that aims to provide “every person… The post Kenvue pushes back on possible Tylenol label change appeared first on Drug Discovery and Development.| Drug Discovery and Development
Advanced Parkinson’s patients can spend hours each day locked in ‘OFF’ states, periods when tremors, rigidity and immobility return as oral medications wear off. The first multi-country real-world data on continuous 24-hour foslevodopa/foscarbidopa infusion shows the approach cut that OFF time by 2.7 hours daily at six months, with improvements across motor symptoms, sleep, pain,… The post First real-world look: AbbVie’s 24-hour foslevodopa/foscarbidopa pump shows symptom gains in P...| Drug Discovery and Development