Stephen Hahn of the MD Anderson Cancer Center generally managed to avoid any controversy in the Nov. 20 Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem.
HONG KONG – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) NDA for surufatinib as a treatment for patients with advanced non-pancreatic neuroendocrine tumors (NET) has been accepted for review by China’s National Medical Products Administration (NMPA).
The U.S. FDA has granted breakthrough device designation for Bioventrix Inc.’s Revivent Tc Transcatheter Ventricular Enhancement System for heart failure following a heart attack. The system is designed to exclude scar tissue that has formed on the left ventricle in a procedure that is less invasive than current medical options and better than drug therapy, allowing healthy heart tissue to function more efficiently. The left ventricle is the heart’s pumping chamber, and scarring can prevent it from contracting and providing the steady circulation of blood that the body needs.
The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.
BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.
Adults with complicated urinary tract infections (cUTIs) and limited or no alternative treatment options could soon receive Shionogi & Co. Ltd.'s cefiderocol following FDA approval for the antibacterial. The approved indication also included kidney infections caused by susceptible gram-negative microorganisms. The new therapy, to be marketed as Fetroja, is expected to be available in early 2020.
LONDON – “Innovation only matters if patients benefit.” So said Guido Rasi, executive director of the EMA, as the agency embarks on the next phase of updating its regulatory science, both to tap into a torrent of new technologies and to ensure drug development generates evidence to demonstrate cost effectiveness and speed up access.
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