Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints.
Shares in Orphazyme A/S cratered after the FDA rejected its arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition where fat builds in tissues and organs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Agenus, Amneal, Applied Therapeutics, Blueprint, Eagle, Innocare, Novartis, Sirnaomics, Turning Point, Xilio.
The U.S. Supreme Court, in a 7-2 opinion dismissing a challenge to the Affordable Care Act (ACA), removed a threat to the future of the Biologics Price Competition and Innovation Act (BPCIA) and the biosimilars pathway it created.
The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptinyx, Aqualung, Biocryst, Braeburn, Dicerna, Emmaus, Starton, United.
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.
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