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Compounding pharmacies rebut Novo’s FDA petition

STAT

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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Opinion: Adding psychotherapy to drug therapy works, but the FDA may not be able to handle it

STAT

Several things were stacked against approval: The FDA greenlights only about 50 new drugs each year. Drug development is a high-risk business with an overall success rate between 10% and 20%.

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STAT+: Pharmacists can make shortage drugs, but at what cost?

STAT

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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STAT+: Liver disease MASH is next target for obesity drugs in development

STAT

A new update of the STAT Obesity Drug Tracker shows that at least 23 — about one-fifth — of the 105 obesity treatments in development or on the market are also being investigated for metabolic dysfunction-associated steatohepatitis, the fatty liver disease known as MASH (and previously called NASH ).

Diabetes 360
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STAT+: After AI protein folding, David Baker’s lab identifies millions of smaller drug candidates

STAT

Now Baker is pushing forward in a different area of drug discovery research. A few years ago, his lab surprised scientists by constructing an AI-powered protein-folding prediction system rivaling Google’s DeepMind AlphaFold.

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STAT+: Roivant autoimmune drug succeeds in eye condition; company to buy back $1.5 billion in stock

STAT

The autoimmune drug, brepocitinib, is being steered by a company called Priovant Therapeutics, which was formed as part of a deal between Roivant and Pfizer in 2021.     It is one of the most-watched compounds in Roivant’s pipeline for multiple autoimmune indications. Continue to STAT+ to read the full story…

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

STAT

The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one).