A February data breach at drug distributor Cencora has exposed the personal medical information of tens of thousands of patients, according to filings with numerous state attorneys general (AG) and…
The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).…
The final version of an International Council of Harmonisation (ICH) guideline that addresses evaluation of the drug-drug interaction (DDI) potential of an investigational drug is ready for adoption and a…
This edition of Quick Notes looks at the FDA clearances for heart monitoring and lung disease diagnostic algorithms, an artificial pancreas app and a bipolar radiofrequency hysteroscopy system. Source: Drug…
An FDA advisory committee voted 7-4 that the risk of serious hypoglycemia seen with Novo Nordisk’s Awiqli insulin outweighed the convenience of its once-a-week dosing regimen for people with type…
Believing “this bill protects women across Louisiana,” Gov. Jeff Landry on Friday signed state legislation classifying the abortion-inducing drugs mifepristone and misoprostol as controlled substances. Source: Drug Industry Daily
The FDA’s draft guidance on platform technology designations for drug development outlines how sponsors can submit a designation request and the benefits of the designation. Source: Drug Industry Daily
Eli Lilly announced on Friday that it has more than doubled its investment in its Lebanon, Ind., manufacturing site with a $5.3 billion commitment that will expand its capacity to…
While Shield, Guardant’s blood-based colorectal cancer screening test, got an overall thumbs-up from an FDA advisory committee, members stressed that it’s no substitute for colonoscopy. Source: Drug Industry Daily
The FDA needs to regain the authority to regulate drugs used in executions, according to nine Democratic senators who Tuesday wrote separate letters to FDA Commissioner Robert Califf and Drug…