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.

Compounding 273

Compounding Compounding Pharmacies Diabetes 273

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.

Compounding Pharmacies 205

Compounding Pharmacies Compounding Hospitals 205

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 215

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.

Compounding 206

Compounding Compounding Pharmacies Chemotherapy 206

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.

Compounding 218

Compounding Diabetes 218

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…

Compounding Pharmacies 177

Compounding Pharmacies Compounding Drug Pricing Drug Development 177

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

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 176

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…

Compounding Pharmacies 186

Compounding Pharmacies Compounding 186

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 193

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 181

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 142

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. 

Compounding Pharmacies 324

Compounding Pharmacies Compounding Diabetes 324

Compounding Pharmacy of America

DECEMBER 23, 2024

Learn how compounding pharmacies ensure safety and reliability through rigorous standards, sterile preparations, and personalized solutions for unique healthcare needs. The post Are Compounding Pharmacies Safe? Everything You Need to Know appeared first on Compounding Pharmacy of America.

Compounding Pharmacies 98

Compounding Pharmacies Compounding 98

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.

Compounding 242

Compounding 242

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 171

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

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 286

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.

Compounding 176

Compounding Compounding Pharmacies Diabetes 176

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 277

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 229

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

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.

Compounding Pharmacies 264

Compounding Pharmacies Compounding Diabetes 264

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 231

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.

Compounding 168

Compounding Compounding Pharmacies Vaccines Immunization 168

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

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 335

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.

Online Pharmacies 307

Online Pharmacies Labelling Compounding Diabetes 307

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 281

STAT

JANUARY 12, 2023

But medical schools have barely started to teach about AI and machine learning — creating knowledge gaps that could compound the damage caused by flawed algorithms and biased decision-support systems. Ready or not, health care is undergoing a massive transformation driven by artificial intelligence. at the University of Michigan.

Medical Schools 340

Medical Schools Compounding 340

Pharmaceutical Technology

APRIL 1, 2024

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

Compounding 98

Compounding 98

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.

Compounding 242

Compounding 242

Pharmaceutical Technology

JUNE 10, 2024

Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.

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Compounding 96

STAT

MARCH 5, 2024

Despite his enthusiasm, there is no published scientific research that has yet demonstrated the compounds in Animal Bioscience’s supplements — which have been on the market for more than a year — reverse or even slow aging in dogs. Continue to STAT+ to read the full story…

Compounding 345

Compounding 345

STAT

AUGUST 31, 2023

Several prior studies have suggested that psilocybin, the psychedelic compound produced by certain types of mushrooms, could be a promising way to treat major depression in people for whom antidepressants or counseling aren’t effective.

Medical Schools 361

Medical Schools Compounding 361