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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+: 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.

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Effective Drug Patent Prosecution Strategies: Securing Your Pharmaceutical Innovations

Drug Patent Watch

According to a 2021 study by the Tufts Center for the Study of Drug Development, the average cost to develop a new drug is a staggering $2.6 A robust patent strategy often involves filing multiple applications at different stages of drug development. billion[1].

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. This obviously presents a huge magnitude of risk for drug developers,” he noted.

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Orphan drugs’ financial success raises questions

pharmaphorum

While in 2021, orphan drugs made up over half of all the US FDA’s approvals, with the figures in European being similarly high – 19 out of 54 approved new active substances. The report estimates that the orphan drug market will grow twice as fast as the non-orphan market, with a 2021 to 2026 compound annual growth rate of 12%.