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.
As debate continues to rage over the approval and pricing of the Alzheimer’s disease therapy Aduhelm (aducanumab), Biogen Inc. CEO Michel Vounatsos said his firm is “taking a position that is very responsible” but has “yet to be understood out there, and we have to do a better job.”
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.
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.
LONDON – Regeneron Pharmaceuticals Inc.’s antibody cocktail, Regen-Cov, has been shown to significantly reduce mortality in seriously ill hospitalized COVID-19 patients who have failed to mount their own immune response against the SARS-CoV-2 virus. Among these seronegative patients, the casirivimab/imdevimab monoclonal antibody mixture reduced deaths by 20% (p=0.001) in the U.K. Recovery trial.
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.
Health Canada is proposing amendments to the Food and Drugs Act that would provide greater oversight of the manufacture of drugs for export. Currently, facilities that manufacture or prepare drugs in Canada for use outside the country are not required to obtain a drug establishment license or to follow Canadian requirements for good manufacturing practices, and they are exempt from fees.
After delaying it twice, the U.S. Department of Health and Human Services (HHS) is proposing to rescind a Trump-era rule that would have given certain low-income patients insulin and injectable epinephrine products at the steeply discounted 340B rate.
Noticeably lacking in the G7 communique following its recent U.K. summit is support for a proposed World Trade Organization waiver on intellectual property related to drugs and other medical products used to prevent, contain or treat COVID-19 infections.
Biogen Inc.’s pricing of its newly approved Alzheimer’s drug, Aduhelm (aducanumab), has made it the latest bull’s eye for lawmakers and advocacy groups targeting U.S. drug prices, especially given the controversy surrounding the drug’s approval, which has resulted in the resignation of three of the 11 members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
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