Sydney Lupkin
speaker
1,087 appearances
111 recordings
3 series
first heard Dec 2024
last heard 4d ago
Sydney Lupkin’s voice in public audio — every appearance, attributed to the second.
Trend
recordings per month · last 12 monthsRecordings per month over the last 12 months — 96 in all, peaking in Sep 2026 with 23.
Appearances
Serepta CEO said the decision to pause all shipments was painful but necessary to ensure a good relationship with the agency.
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Sidney Lupkin, NPR News.
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Rock legend
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Serepta therapeutics says it will continue shipments of Elevidus, a gene therapy for patients with Duchenne muscular dystrophy for patients who can still walk.
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The company paused shipments for patients who are unable to walk on their own following two deaths from acute liver failure.
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A third patient died in a clinical trial for another Serepta gene therapy, according to the FDA.
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Serepta says it first learned FDA wanted a halt to all shipments of Elevitis from media reports and only got word from the agency later.
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Since there is no new safety data for patients who are able to walk, the company says it will continue to ship Elevitus.
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Sydney Lupkin, NPR News.
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The Texas
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The federal government and the pharmaceuticals industry are about to go head-to-head once again. In its last full weekday in office, the Biden administration has named the next 15 drugs up for price negotiation in Medicare. Ozempic is on the list.
The type 2 diabetes blockbuster drug is joined by its obesity drug cousin, Wagovi, as well as drugs for various cancers, asthma, psoriasis, and bipolar disorder. The government can't pick just any drugs in Medicare. There are certain rules laid out in the Inflation Reduction Act that say which drugs are eligible. The negotiations will take place in the coming months. Sydney Lufkin, NPR News.
Yeah, hi, Scott.
Yeah. And in most circumstances, it would be celebrated all around. But in this case, many people will end up spending more to manage their obesity. Here's what's happening. Terzepatide is the active ingredient in Eli Lilly's Zepbound for Obesity and Manjaro for Diabetes.
Specialized pharmacies called compounding pharmacies have been legally allowed to make what are essentially copies of terzepatide Because the brand name drugs were in shortage. And the compounded versions of the medicines were a lot cheaper. A few hundred dollars a month for patients compared with $1,000 or more for the brand name drugs.
Yeah, so the stakes are high. In October, FDA first said the shortage was over, but a trade group for the largest compounding pharmacies sued the FDA, challenging that determination. The compounders said there was no way the shortage could be over because many patients still couldn't fill their name-brand prescriptions
And they allege that the FDA hadn't determined how many people would need to make the switch from the compounded to the name brand drugs either. So the FDA took another look and for a second time declared the triseptide shortage resolved.
The agency says it took a look at many factors, including the drug manufacturer's inventory data, projected demand. It says it also spoke to patients, healthcare providers, and compounding pharmacies. Bottom line, the agency said it thinks Eli Lilly can make enough. Lilly said in a statement that the FDA decision reflects the company's hard work to expand its manufacturing capacity.
and meet patient needs. So compounding pharmacies will need to stop making and selling the compounded versions in February or March, depending on their size.
Yes, though the exact number is hard to pin down. I've heard from lots of patients who consider them a lifeline, and that's because many health insurers won't cover the drugs for weight loss. Medicare, for instance, is banned from covering drugs for weight loss because of an old law written at a time when having obesity was considered more of a personal failure than a health condition.
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