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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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This is the end of GLP-1 compounding as we know it

STAT

Good morning, we’ve got a bunch of news this morning about GLP-1 drugscompounding, and biotechs’ interactions with the FDA. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Let’s get into it.

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Judge rules against compounding group; Hims’ shares fall

STAT

Today, we unpack Marty Makary’s Senate  confirmation hearing, see a new ruling against GLP-1 compounders, examine the effects of the NIH patent freeze, and explore the tumultuous biotech job market.   Sign up  to get our biotech newsletter in your inbox. Read the rest…

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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+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid. But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work.

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STAT+: Pharmalittle: We’re reading about Lilly lawsuits, Novo Nordisk fires and much more

STAT

We have adjusted our settings to accept postcards and telegrams… After taking legal action last year, Eli Lilly filed even more lawsuits against several spas, compounders and wellness centers over unapproved versions of tirzepatide, which is the active ingredient in Mounjaro and Zepbound,   STAT notes.

Diabetes 294
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Effective Drug Patent Prosecution Strategies: Securing Your Pharmaceutical Innovations

Drug Patent Watch

Each stage of drug development can potentially yield patentable inventions. From initial compound discovery to formulation improvements, every step offers opportunities for patent protection.” Balancing Profit and Public Health Pharmaceutical companies face increasing scrutiny over drug pricing and access.