Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation — our choice today is maple cinnamon French toast. We would agree that the heat is a bit unusual for this time of the year, but there is a global warming trend afoot. In any event, there is work to be done, so as always, we have assembled a few items of interest for you. After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch. …
A U.S. federal appeals court panel is allowing continued access to an abortion pill as a legal fight around its approval continues, but with some added restrictions, STAT writes. Under the ruling, the drug, mifepristone, will remain available, but the panel said it could no longer be sent to patients through the mail and could only be used up to seven weeks into a pregnancy, not 10. The order would remain in place until the full case is heard on its merits. Last week, a federal judge in Texas ruled the U.S. Food and Drug Administration had improperly approved the drug in 2000, threatening access to the medication around the country. There is more from The New York Times.
U.S. Sen. Bernie Sanders (I-Vt.) plans to call the chief executives of the largest insulin manufacturers to testify before his health committee, according to STAT. The move will keep the pressure on the companies over their prices despite the fact that they have said they plan to lower the list price of their older insulin products. Sanders has alluded publicly to plans to hold a hearing on insulin affordability, but it was not clear that he planned to ask the executives of insulin makers to testify. The committee is targeting next month for the hearing, which will be the latest installment in his campaign to hold pharmaceutical executives accountable for pricing practices.
FDA reviewers were leaning toward rejecting a closely watched gene therapy for Duchenne muscular dystrophy made by Sarepta Therapeutics, prompting a top official to intervene earlier this year, STAT reports. Inside the FDA office that oversees gene therapies, some staff had reached a non-binding conclusion that the gene therapy should be rejected. Peter Marks, a top FDA official and vocal advocate for faster approvals of gene therapies, stepped in and directed staff to schedule a public hearing on the therapy on May 12. Sarepta announced the scheduling of the public hearing last month.
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