FDA Updates: Merck’s Pneumococcal Vaccine Leads the Week

July 24, 2021

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.

Best Practices to Define, Care for Lung Cancer

July 19, 2021

When wondering what step to take first after learning of your cancer diagnosis, assembling the right care team and creating a treatment plan designed uniquely is important to get you on the right track. Comprehensive biomarker testing can then help identify your type of lung cancer and help move steps forward for proper care.

FDA Update: Roxadustat AdComm Decision Leads the Week

July 17, 2021

An advisory committee recommends against approving an anemia drug. Darzalex Faspro receives another indication, Bayer receives approval for Kerendia for chronic kidney disease, and FDA delays its decision on sNDAs for JAK inhibitor therapies for atopic dermatitis.

FDA Update: Keytruda and Aduhelm News Leads the Week

July 10, 2021

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.

Getting Clinical Trials, Cancer Screenings Back on Track with Tech to Avoid Wave of Patients Post-COVID

July 07, 2021

MHE Associate Editor, Briana Contreras, spoke with CEO of Inteliquet, a cancer solutions provider that strives to match patients to clinical trials accurately and promptly in healthcare, Marie Lamont. In this episode Marie discusses the challenges that have affected clinical trials and cancer screenings and how to get trials back on track through technology to avoid the wave of undiagnosed patients post-COVID. She also shared how broadening them through diversity can improve trials.