STAT

DECEMBER 19, 2024

The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

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Compounding Compounding Pharmacies Diabetes 232

STAT

DECEMBER 4, 2024

Also, compounding pharmacies fire back at Novo Nordisk for its assertion that GLP-1 drugs are too difficult to compound. Lots today on GLP-1s: First we see tirzepatide outperforming semaglutide in a head-to-head study in obesity. Also, a Michael Gilman company pivots and more. Read the rest…

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Compounding Pharmacies Compounding Drug Pricing Drug Development 264

STAT

MAY 22, 2024

Australia to ban compounded versions of blockbuster drugs Ozempic and Mounjaro, Reuters reports. But the country’s health minister, Mark Butler, says that it’s harder to ensure the safety of compounded drugs, noting that one Australian was hospitalized after taking a compounded GLP-1 product.

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Compounding Labelling Hospitals 263

STAT

NOVEMBER 30, 2023

Novo Nordisk filed lawsuits against two compounding pharmacies for selling adulterated and misbranded compounded drugs claiming to contain semaglutide, the active ingredient in Wegovy and Ozempic (see here and here ). Testing of compounded drugs from these pharmacies revealed unknown impurities up to 33%, the company claims.

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Compounding Compounding Pharmacies Chemotherapy 277

STAT

MAY 15, 2023

At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need.

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Compounding Pharmacies Compounding Hospitals 246

STAT

OCTOBER 23, 2024

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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Compounding Compounding Pharmacies Biosimilars Documentation 257

STAT

NOVEMBER 6, 2024

… Novo Nordisk disclosed that it is aware of 10 deaths and 100 hospitalizations resulting from people taking compounded copies of its weight loss and diabetes drugs , Reuters writes. We enjoy your insights and perspectives. Given all the U.S. could inject themselves with a product that was not regulated, approved, or inspected.

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Compounding Compounding Pharmacies Diabetes Hospitals 268

STAT

SEPTEMBER 19, 2024

Hims & Hers Health plans to sell compounded versions of Novo Nordisk’s popular weight loss drug Wegovy to patients in certain professions for $99 a month , Reuters says. Compounded GLP-1 injections are fulfilled and shipped from Hims & Hers affiliated pharmacies and are regulated by the FDA.

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Compounding Compounding Pharmacies Packaging 255

STAT

OCTOBER 12, 2022

Food and Drug Administration and a trade group that represents large compound pharmacies have resolved a long-running dispute over the use of bulk ingredients, clearing the way for some compounded medicines to become available more quickly. Continue to STAT+ to read the full story…

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Compounding Pharmacies Compounding 245

STAT

JULY 26, 2023

One of the largest compound pharmacy operations in the U.S. Yet the compounder failed to investigate the causes or take adequate corrective or preventive actions to mitigate the risk of formation. The Food and Drug Administration found several issues that raised the possibility of contamination during an inspection of an Allentown, Pa.,

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Compounding Hospitals Compounding Pharmacies 246

STAT

SEPTEMBER 13, 2024

I first met Jane (not her real name, of course) on a Friday afternoon in our clinic. She was referred for further evaluation of her chest pain, which, in the context of her family history of early-onset heart attacks and her morbid obesity, understandably concerned her primary care doctor.

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Compounding 334

STAT

AUGUST 10, 2023

In late May, the Food and Drug Administration said it received a “few” adverse event reports concerning compounded versions of the injectable medicines, which both contain the same active ingredient, known as semaglutide.

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Compounding Diabetes 246

STAT

DECEMBER 4, 2024

  A trade group for compounding pharmacies slammed an attempt by Novo Nordisk to convince the U.S. Food and Drug Administration that semaglutide — the key ingredient in its diabetes and obesity drugs — should be added to a list of medicines that are too difficult to compound.

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Compounding Compounding Pharmacies Diabetes Documentation 175

STAT

SEPTEMBER 20, 2023

… As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. The drug company accused four compound pharmacies of violating state laws because those versions were not approved by the U.S.

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Compounding Compounding Pharmacies Diabetes 249

STAT

OCTOBER 8, 2024

… A trade group representing large compounding pharmacies has sued the U.S. 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. Have a grand day, everyone, and do stay in touch.

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Compounding Compounding Pharmacies Vaccines Immunity 247

PharmaVoice

DECEMBER 11, 2024

The agency has yet to make a decision about keeping tirzepatide on or off of its shortage list — letting compound pharmacies continue their lucrative operations for now.

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Compounding Compounding Pharmacies 162

STAT

OCTOBER 11, 2024

The Food and Drug Administration on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, from its shortage list, and, for the time being, would not pursue regulatory action against certain compounding pharmacies making copies of the drugs. 

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Compounding Pharmacies Compounding Diabetes 350

STAT

AUGUST 29, 2024

Hims & Hers, one of the largest publicly traded telehealth companies in the country, has supercharged its business in the last several months by offering compounded versions of the patented weight loss drugs known as GLP-1s. That has regularly been the case lately with GLP-1 drugs marketed by Novo Nordisk and Eli Lilly.  

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Compounding 358

STAT

SEPTEMBER 21, 2024

First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

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Compounding 301

STAT

OCTOBER 25, 2024

By law, that should have prohibited compound pharmacies from making copies of the drug, as they’re allowed to do so only when the treatment is on the shortage list.  The agency then made a sudden about-face , saying it would reconsider its decision and allow compounders to continue for the meantime.

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Compounding Pharmacies Compounding Diabetes 356

STAT

OCTOBER 30, 2024

Over the past two years, patients seeking treatment have been turning to compounding pharmacies, which make cheaper copies of branded treatments and are legally allowed to do so only when the branded treatments are listed on the FDA’s shortage list.

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Compounding Pharmacies Compounding Diabetes 344

BioPharma Dive

DECEMBER 2, 2024

The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.

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Compounding Compounding Pharmacies Diabetes 122

PharmaVoice

DECEMBER 5, 2022

GATC Health is driving a novel approach it believes could work for several major neurological conditions.

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Compounding 262

STAT

OCTOBER 10, 2024

Top of the morning to you and a fine one it is. Blue skies, cool breezes, and plenty of chirping birds are enveloping the comfy Pharmalot campus, which is cause to fire up the coffee kettle for yet another cup of stimulation. Our choice today is strawberry creme — sweets for the sweet, you know.

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Compounding 248

STAT

JULY 20, 2023

The tornado that struck parts of North Carolina on Wednesday not only damaged the immediate area, but could soon make it much harder for countless people across the U.S. and around the world to obtain needed medicines the next time they visit a hospital. Among the damaged buildings was a Pfizer plant in Rocky Mountain, N.C. hospitals.

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Compounding Hospitals 246

STAT

OCTOBER 20, 2023

Hospitals’ reliance on pharmacist-made drugs, a practice called compounding, has risen in step with worsening drug shortages. When the American Society of Health-System Pharmacists surveyed its members this past summer, 59% said they increased purchases from compounders because of drug shortages.

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Compounding Chemotherapy Hospitals Drug Development 315

STAT

OCTOBER 25, 2024

By law, that should have prohibited compound pharmacies from making copies of the drug, as they’re allowed to do so only when the treatment is on the shortage list.  The agency then made a sudden about-face , saying it would reconsider its decision and allow compounders to continue for the meantime.

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Compounding Pharmacies Compounding Diabetes 284

STAT

OCTOBER 24, 2023

A traditional Chinese medicine compound used for cardiac benefits might help reduce the incidence of major adverse cardiac and cerebrovascular events and even cardiac death rates, according to a new study published Tuesday in the Journal of the American Medical Association. However, some outside experts expressed skepticism about the result.

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Compounding 307

pharmaphorum

OCTOBER 14, 2024

Faced with lawsuit, FDA rethinks block on compounding pharmacies making Eli Lilly's diabetes and obesity drug tirzepatide

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Compounding Compounding Pharmacies Diabetes 110

STAT

JULY 18, 2024

Both chemicals are psychoactive compounds found in magic mushrooms, which make users hallucinate. It identified the Schedule I drug psilocin in mushroom candies sold under the brand names Diamond Shruumz and Wonderland Legal Psychedelics. A product sold under the brand Urb contained both psilocybin and psilocin. Read the rest…

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Compounding 341

STAT

AUGUST 2, 2024

In the face of ongoing shortages of the obesity and diabetes medications known as GLP-1s, patients have resorted to a wide array of sources for the drugs, including medical spas and telehealth sites that prescribe compounded versions of the drugs.

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Online Pharmacies Labelling Compounding Diabetes 360

pharmaphorum

OCTOBER 23, 2024

Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.

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Compounding Compounding Pharmacies Diabetes 116

Pharmaceutical Technology

APRIL 18, 2024

psychedelic compounds for mental disorders. Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0

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Compounding 98

STAT

NOVEMBER 4, 2024

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so predictable routine of online meetings, phone calls, and deadlines has returned. But you knew this would happen, yes? The world, such as it is, continues to spin.

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Compounding Pharmaceutical Companies Pharmaceutical Companies 262

STAT

SEPTEMBER 13, 2023

Their isolation and vulnerability compounded the challenges of caring for a newborn, and drove many of these mothers into anxiety and depression. Some mothers had to return to work themselves while they were still recovering from childbirth, or else risk losing their jobs in the fields and fruit-packing houses. Read the rest…

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Compounding 358

Express Pharma

JULY 28, 2024

Food and Drug Administration recently warned patients and doctors about dosing errors associated with compounded versions of Novo Nordisk’s weight-loss and diabetes drugs. It urged healthcare providers and compounders to provide the appropriate syringe size and counsel patients on how to measure the dose,” informed the statement.

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Compounding Diabetes 103

STAT

OCTOBER 13, 2023

Due to a shortage of a widely used compounded medicine for serious eye diseases, two leading ophthalmologic groups want Medicare contractors to halt practices that limit coverage of other — albeit costlier — treatments over concerns about patient access. Continue to STAT+ to read the full story…

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Compounding 290