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The FDA launched an agencywide initiative in July — the FDA Inspectional Affairs Council (FIAC) — meant to make inspections more consistent, but four months later questions remain about its day-to-day operations. Read More
A bill that functions as a followup to the 21st Century Cures Act of 2016 has been introduced that includes many provisions that would affect the FDA and drugmakers. Read More
The COVID-19 vaccine partnership was the result of a four-year collaboration originally meant to develop vaccines for several other diseases. Read More
Majority Leader Steny Hoyer (D-Md.) said House Democrats plan to vote Thursday — or at the latest Friday — on the nearly $2 trillion Build Back Better Act, which contains compromise provisions meant to lower the price of prescription drugs. Read More
Aduhlem is contributing to a 14.5 percent increase in 2022 Medicare Part B premiums, even though the Centers for Medicare and Medicaid Services (CMS) hasn’t yet decided whether it will pay for the controversial Alzheimer’s treatment. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has recommended that the National Health Service (NHS) not offer BioMarin Pharmaceutical’s Vimizim (elosulfase alfa) for treating mucopolysaccharidosis type 4A syndrome, also known as Morquio A syndrome. Read More
Three days before the clock was set to run out on the legality of Janet Woodcock serving as acting commissioner of the FDA, President Biden has announced that he will nominate Robert Califf to take a second turn at occupying the top spot at the agency. Read More
In order to be cost-effective relative to standard Alzheimer’s care, Aduhelm — the newly approved Alzheimer’s antibody — would have to cost no more than $3,000 per year, rather than the current $56,000 price tag. Read More