Good morning, everyone, and how are you today? Hazy skies are enveloping the frosty Pharmalot campus, where the official mascot is running about watering the weeds and the short person is sleeping in. As for us, we are busy firing up the trusty coffee kettle and brewing cups of stimulation. Our choice today is roasted coconut, for those who track this sort of thing. Please feel free to join us. Meanwhile, there is much to do. So time to get cracking. Once again, we have assembled a list of interesting items to help you get started. We hope you have a smashing day and conquer the world. And as always, do keep in touch. …
The federal judge who could upend access to a widely used abortion medication pressed government lawyers in a hearing Wednesday about the safety and approval process for the drug, which has been on the market in the U.S. for more than two decades, The Washington Post reports. While the antiabortion group challenging the drug acknowledged there is no precedent for a court to order the suspension of a long-approved medication, U.S. District Court Judge Matthew Kacsmaryk seemed open to the argument that mifepristone had not been properly vetted — claims the U.S. Food and Drug Administration and leading health organizations strongly contest.
The Alzheimer’s Association has deployed 1,000 people diagnosed with, or caring for someone with the disease, to meet with all 535 members of Congress and urge them to press Medicare for early access to a new class of drugs, beginning with lecanemab, that promise to slow the disease, Reuters tells us. The grassroots lobbying campaign, which has not been reported in detail, is being led by state-based chapters. The effort is aimed at persuading Medicare officials to provide “full and unrestricted coverage” to the drugs when they first reach the U.S. market under an accelerated approval from the FDA.
A Novartis drug used to extend the lives of people with advanced prostate cancer is in short supply and will be for months, leaving some patients with no treatment option as the manufacturer works to ramp up production, The Wall Street Journal notes. The FDA said last week the availability of Pluvicto is limited as Novartis struggles to meet demand. The drugmaker said the shortage stems from manufacturing and delivery issues. The drug is made in Italy and Novartis is seeking FDA approval to manufacture at a site in New Jersey. Novartis briefly halted production last year over manufacturing issues.