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STAT+: Compounding group sues FDA for removing Lilly’s obesity drug from its shortages list

STAT

A trade group representing large compounding pharmacies has sued the U.S. Food and Drug Administration for a “reckless and arbitrary” decision to remove a widely prescribed Eli Lilly drug for combating diabetes and obesity from an official shortages list.

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STAT+: Pharmalittle: We’re watching a ban compounded versions of GLP-1s, a Biogen acquisition, and more

STAT

Data presented this week at the Digestive Disease Week meeting in D.C. Australia to ban compounded versions of blockbuster drugs Ozempic and Mounjaro, Reuters reports. A drug often used off-label to treat alcohol use disorder might provide better benefits than therapies approved for this indication, STAT tells us.

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STAT+: Pharmalittle: We’re reading about compounders suing the FDA, Biogen turning to telehealth, and more

STAT

So join us as we hoist the ever-present cup of stimulation — our choice today is coconut rum — and attack the fast-growing to-do list. … A trade group representing large compounding pharmacies has sued the U.S. We trust you have your own hectic agendas. Have a grand day, everyone, and do stay in touch.

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Elevating Sterile Compounding Accuracy

Omnicell

Terri Albarano, PharmD Director, Autonomous Pharmacy, Omnicell Sterile compounding safety is one of the biggest challenges for the pharmacy supply chain. Health systems are expected to compound IV preparations with increasingly complex regulations, rising drug costs, and supply disruptions. Injectable medications cause 1.2

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Reverse Your Reliance on 503Bs for Compounded Sterile Products

Omnicell

Many often rely on 503B outsourcing pharmacies for their pre-mixed compounded sterile products. At the University of Maryland Medical Center, we reduced our need for 503B vendors by implementing an IV robotics insourcing program for compounded sterile products (CSPs).

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STAT+: With an old approach but new energy, ADCs take center stage as promising cancer treatments

STAT

MADRID — If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting , a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates.

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Enforcement Trends: CDER Presentation Confirms Fewer Warning Letters Are Issued by FDA for OAI Inspections

The FDA Law Blog

Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. By Douglas B. OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance.

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