Archive for April 2022

The European Commission has approved Merck’s blockbuster oncology drug Keytruda (pembrolizumab) for six new indications, including persistent, recurrent or metastatic cervical cancer. Source: Drug Industry Daily

Government Accountability Office (GAO) officials testified on Friday before a House subcommittee where they highlighted the lack of procedures in four public health agencies — including the FDA — for reporting potential political interference. Source: Drug Industry Daily

NovoNordisk has reported that its once-a-week form of insulin controlled blood sugar as well as short-acting insulin with a similar rate of hypoglycemic events in a late-stage trial. Source: Drug Industry Daily

The FDA has announced tentative dates for its vaccine-related advisory committee to meet to discuss the much-anticipated full applications for Emergency Use Authorization (EUA) that it expects any day from COVID-19 vaccine manufacturers for children under age six. Source: Drug Industry Daily

Shareholders of the U.S.’ big three COVID-19 vaccine makers have voted no on proposals asking the companies to share their intellectual property with low- and middle-income countries (LMICs) so that those countries could make their own versions of the vaccines. Source: Drug Industry Daily

Eli Lilly has reported that its investigational once-weekly injectable treatment, tirzepatide, led to significant weight loss in obese and overweight patients in a late-stage study. Source: Drug Industry Daily

Trials of drugs to treat Crohn’s disease should add reduction of intestinal inflammation to their symptom-relief endpoints, according to an FDA draft guidance released Thursday in tandem with a draft guidance for conducting ulcerative colitis trials. Source: Drug Industry Daily

Amgen disclosed this week that the Internal Revenue Service (IRS) is seeking $7.1 billion in back taxes and fines relating to how the drugmaker split profits between its U.S. and Puerto Rican manufacturing hubs. Source: Drug Industry Daily

IQVIA has come out with a new report that looks back at the historic timelines achieved by the COVID-19 vaccine trials, outlining lessons learned from the unprecedented research effort that have application now and in future research. Source: Drug Industry Daily

Moderna announced yesterday that it has filed for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in children less than six years old as the FDA comes under intense pressure from many sides to swiftly authorize the vaccine for this population. Source: Drug Industry Daily