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Ardelyx said the FDA will convene an advisory committee meeting to review the company’s Xphozah (tenapanor) as a treatment for the control of serum phosphorus in adults suffering from chronic kidney disease who are on dialysis. Read More
Axsome Therapeutics said it anticipates the FDA will decline to approve its experimental drug AXS-07 for the acute treatment of migraines because of problems related to its chemistry, manufacturing and controls (CMC) processes. Read More
The ABPI also issued a reprimand to Janssen for failing to “maintain oversight and high standards” in a nurse-led homecare service involving its immunosuppressive drug Stelara (ustekinumab). Read More
Starting July 1, Canada’s Patented Medicine Prices Review Board will no longer make price comparisons with countries with the highest drug prices and will include more countries in its benchmarking. Read More
Abaco Partners, operating as Surefil, has received a seven-observation Form 483 from the FDA after a November 2021 inspection of the company’s Grand Rapids, Mich., manufacturing facility turned up observations of testing and other quality lapses. Read More
The FDA announced Friday that it’s working on a project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured submission approach. Read More
The World Health Organization (WHO) has issued a “strong recommendation” for Pfizer’s oral antiviral Paxlovid for mild and moderate COVID-19 in people at highest risk of hospitalization, such as unvaccinated, older or immunosuppressed patients. Read More
The FDA’s latest annual report on the postmarket performance of drug and biologics firms, which covers the fiscal year Oct. 2, 2019, to Sept. 30, 2020, says 75 percent of the 816 unique postmarket requirements (PMRs) and postmarket commitments (PMCs) in the FDA’s system were on schedule. But the agency said many of the studies failed to file timely reports. Read More
The FDA’s Oncologic Drugs Advisory Committee voted nearly unanimously (16 for and one abstaining) to require makers of phosphatidylinositol 3-kinase (PI3K) inhibitors in blood cancers to complete randomized phase 3 trials with active comparators before they submit applications for approval. Read More