Rep. Peter Welch, D-Vt., has introduced legislation that would allow patients, pharmacists and wholesalers to import cheaper insulin from Canada and other countries with similar safety standards as the US. Under the bill, patients would still need prescriptions to purchase the insulin, while the FDA would be required to certify and inspect all foreign insulin exporters.
FDA Commissioner Scott Gottlieb said federal health agencies may step in if states don't tighten laws on vaccine exemptions for children amid the ongoing measles outbreak but didn't specify the timeline and kind of federal action. "Some states are engaging in such wide exemptions that they're creating the opportunity for outbreaks on a scale that is going to have national implications," Gottlieb said.
Merck's supplemental marketing application for the use of Keytruda, or pembrolizumab, as a treatment for patients with advanced small cell lung cancer whose disease progressed after at least two lines of therapy was granted priority review status by the FDA. The agency set a PDUFA date of June 17.
The FDA has approved Intellipharmaceutics' generic version of Pfizer's Pristiq, or desvenlafaxine, an antidepressant drug.
The US and the EU have agreed to collaborate on standards for unique device identifier databases. The European Commission's Executive Working Group notes the agencies will create a plan to test the compatibility of their databases.
European regulators have granted Edwards Lifesciences CE mark approval for its Pascal transcatheter valve repair system. The device is undergoing a pivotal trial in the US to support FDA clearance.
Hill's Pet Nutrition is facing three separate civil lawsuits filed by pet owners, alleging their dogs were sickened or died after consuming the company's canned pet foods, which reportedly contained excessive levels of vitamin D. One suit says the company delayed informing consumers and regulatory agencies about the issue.
The Cigar Association of America and two other trade groups representing the cigar industry have filed an appeal to the US Court of Appeals for the District of Columbia Circuit
saying the FDA's new health warning label requirements for pipe tobacco and cigars violate the free speech rights of manufacturers. The groups are calling for the requirements to be struck down.
The FDA accepted under priority review status Agios' supplemental marketing application for Tibsovo, or ivosidenib, being developed as a treatment for patients with newly diagnosed IDH1 mutation-positive acute myeloid leukemia. The agency set a PDUFA date of June 21.
Individuals with previously untreated advanced clear-cell renal cell carcinoma who received pembrolizumab plus axitinib had higher rates of survival at 12.8 months follow-up and longer median progression-free survival, compared with those who received sunitinib alone, according to a study in The New England Journal of Medicine. Another study in the same journal showed prolonged median progression-free survival among patients with advanced RCC who had programmed death ligand 1-positive tumors in the avelumab plus axitinib group, compared with those in the sunitinib group.
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