With paralysis affecting more than 5 million Americans, devices that serve as brain-computer interfaces (BCIs) are increasingly important, even if few are commercially available. The FDA has responded to the predicament with a leapfrog guidance, a preliminary form of guidance designed to foster more interaction with industry and encourage developers to move along on development programs for devices that will aid patients in restoring lost motor and/or sensory capabilities.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ormo, Stratatech.
Blueprint Medicines Corp. gained the FDA’s nod for Ayvakit (avapritinib) to treat systemic mastocytosis (SM), adding another indication to the KIT inhibitor’s label. For the first time, patients have available a targeted therapy designed to block D816V mutant KIT, the central driver of the disease.
Daiichi Sankyo Co. Ltd. has received conditional approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its oncolytic virus Delytact (teserpaturev) to treat malignant glioma.
While phase I-III clinical trial data continue to rise above the same timeframe in 2020, the gap is closing and a smaller percentage of this year’s reports are focused on the COVID-19 pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Ascentage, Asieris, Autolus, Beigene, Cerevel, Eton, Immunitybio, Jounce, Oryzon, Pharmather, Verisim.
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries.
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept).
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment.