FDA Directs Knockoff Weight Loss Drugmakers To Halt Operations
Patients will lose access to cheaper versions of the blockbuster drugs after the agency shuts down the multibillion-dollar industry now that the drug shortage has ended. Also in the news: Eli Lilly's weight loss pill, a Semler Scientific settlement, breast cancer AI, and more.
The New York Times:
Patients Cut Off From Cheaper Obesity Drugs As FDA Halts Sales Of Copycats
Hundreds of thousands of Americans stand to soon lose their access to cheaper weight-loss drugs, with a federal crackdown on copycat versions threatening to disrupt treatment and raise costs. The Food and Drug Administration has ordered producers and sellers of the less expensive products to wind down operations in the coming weeks now that it has declared there are no longer shortages of the blockbuster drugs Wegovy and Zepbound. (Robbins and Blum, 4/16)
The New York Times:
Daily Pill May Work As Well As Ozempic For Weight Loss And Blood Sugar
A daily pill may be as effective in lowering blood sugar and aiding weight loss in people with Type 2 diabetes as the popular injectable drugs Mounjaro and Ozempic, according to results of a clinical trial announced by Eli Lilly on Thursday morning. (Kolata, 4/17)
Time:
How A New Weight-Loss Pill Could Transform Health
If orforglipron is eventually approved by federal regulators, it would become the first GLP-1 oral drug for weight loss to hit the market. The implications—if Lilly’s drug makes it through the testing and review process—could be transformative, not just for the company, but for patients. (Park, 4/17)
In other pharma and tech developments —
Stat:
Device Maker That Helped UnitedHealth Collect Billions Offers To Settle Fraud Claims With DOJ
Semler Scientific has offered to pay the Department of Justice nearly $30 million to settle federal health care fraud claims related to its peripheral artery disease test, QuantaFlo — a product used by UnitedHealth Group and other large insurers. (Lawrence, 4/16)
Stat:
To Speed Adoption Of Breast Cancer AI, A Radiology Network Plots An Acquisition
RadNet, which runs nearly 400 radiology imaging centers in the United States, wants to put artificial intelligence into breast imaging. Over the last five years, the company has moved aggressively to expand its AI capabilities, deploying the technology for breast cancer screenings at its radiology practices. (Palmer, 4/17)
CIDRAP:
Paring PPE To Just N95s In Pandemic Kept Hospital Staff Safe, Slashed Waste And Costs, Study Finds
Limiting the use of personal protective equipment (PPE) to only N95 respirators late in the COVID-19 pandemic in Singapore healthcare facilities kept staff safe, reduced plastic waste and carbon emissions, and lowered related costs, a JAMA Network Open study concludes. (Van Beusekom, 4/16)
In global news —
AP:
European Regulators OK Alzheimer's Treatment Leqembi After Initial Doubts
European regulators have finally approved the Alzheimer’s treatment Leqembi after an advisory committee initially rejected the drug last summer and then reconsidered it. The infused treatment from Japanese drugmaker Eisai and Biogen received approval for patients in early stages of the fatal, mind-robbing disease. The decision applies to all 27 members of the European Union plus Norway, Iceland and Liechtenstein, the drugmakers said late Tuesday. (Murphy, 4/16)
Bloomberg:
Climate Change Threatens World’s Supply Of Blood, Study Warns
Climate change and increasingly extreme weather are taking a toll on global supplies of blood, endangering the lives of people with life-threatening injuries and conditions, a new study has found. Extreme weather events and natural disasters such as bushfires and floods, fueled by rising global temperatures, are disrupting medical professionals in their efforts to collect, testing, transport and store blood, according to a study published in The Lancet Planetary Health this week. (Kan, 4/17)
