News
AI predicts liver cancer risk with "high accuracy"
8+ hour, 12+ min ago (554+ words) A machine learning (ML) tool that analyses electronic health record data, test results, and patient demographics can help clinicians identify people at high risk of hepatocellular carcinoma (HCC), the most common form of liver cancer. That is the conclusion of a…...
Wave's stock wavers on obesity drug data
2+ hour, 51+ min ago (489+ words) Wave Life Sciences has said new clinical trial results with its non-incretin therapy for weight loss are positive " but investors don't seem to agree. The data reveal from the phase 1 INLIGHT study of WVE-007 " an oligonucleotide-based gene-silencing drug designed to…...
FDA clears Denali's 'game-changer' Hunter syndrome drug
10+ hour, 35+ min ago (450+ words) Denali Therapeutics' Avlayah is the first drug for neurological complications associated with the rare lysosomal storage disorder Hunter syndrome to be approved in the US. Enzyme replacement therapy Avlayah (tividenofusp alfa) works in the same way as the only other…...
Corcept gets FDA OK for first-in-class ovarian cancer drug
9+ hour, 19+ min ago (474+ words) Almost four months ahead of schedule, Corcept Therapeutics' selective glucocorticoid receptor antagonist (SGRA) relacorilant has been cleared for sale in the US as a treatment for ovarian, fallopian tube, or primary peritoneal cancer. The early FDA approval " under the Lifyorli…...
Regulatory setback or scientific signal? The case for human-relevant evidence
10+ hour, 14+ min ago (680+ words) The FDA's recent rejection of a high-profile gene therapy application from Regenxbio has reignited a debate that has been quietly building across the industry. The therapy had generated considerable optimism, supported by preclinical data and regulatory engagement. Yet, when it…...
Using patient data to fill in GLP-1 blind spots, with Phil Johnson
1+ day, 11+ hour ago (150+ words) Using patient data to fill in GLP-1 blind spots, with Phil Johnson'pharmaphorum Using patient data to fill in GLP-1 blind spots, with Phil Johnson The GLP-1 market is huge and growing, and depending on how patients acquire and pay for…...
Anavex sinks after pulling Alzheimer's filing in EU
1+ day, 1+ hour ago (468+ words) Shares in Anavex Life Sciences lost more than a third of their value today after the company abandoned a filing for its Alzheimer's disease therapy, blarcamesine, in the EU. The New York biotech said it had withdrawn the marketing authorisation…...
ImmunityBio warned by FDA over 'misleading' Anktiva content
1+ day, 3+ hour ago (526+ words) The FDA has sent a warning letter to ImmunityBio over "false and misleading" comments made by its executive chairman, biotech billionaire Patrick Soon-Shiong, on a podcast. The letter, addressed to ImmunityBio chief executive Richard Adcock, comes from the FDA's Office…...
Novo unveils first data for 'triple G' agonist in diabetes
1+ day, 8+ hour ago (495+ words) Novo Nordisk has reported the first mid-stage clinical data with its triple G agonist for diabetes in China, as it starts an international trials programme. The drug candidate, UBT251, acts on GLP-1, GIP and glucagon receptors and is being jointly developed…...
MSD taps Quotient for IBD drug targets in $2.2bn deal
2+ day, 6+ hour ago (423+ words) MSD is paying $20 million upfront to activate an alliance with Flagship Pioneering's Quotient Therapeutics that will focus on finding new therapeutic targets in inflammatory bowel disease (IBD). The deal also puts Cambridge, Massachusetts-based Quotient in line for development, regulatory and…...