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The European Medicines Agency (EMA) has issued a final guidance for drug developers on the quality data needed to support applications to its Priority Medicines (PRIME) program and other unmet medical need review pathways. Read More
India is making moves to reduce its dependence on countries like China for sourcing active pharmaceutical ingredients (API) used in manufacturing regulated medicines. Read More
The FDA has expanded its approval of Gilead Sciences’ Veklury (remdesivir) for pediatric patients 28 days and older weighing at least 6.6 pounds who have tested positive for COVID-19 and are either hospitalized or are at high risk of developing severe COVID-19. Read More
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