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The FDA’s 505(b)(2) pathway is an underestimated engine of value creation

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The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.

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Supernus and Indivior merge to create CNS mega-company with 11 approved drugs

Supernus and Indivior merge to create CNS mega-company with 11 approved drugs

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Supernus Pharmaceuticals and Indivior Pharmaceuticals are outlining a combined expected $2.2 billion in annual revenue, plus $125 million in cost savings that will include “natural redundancies.”​ ​Read More

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STAT+: Is there a pharma mega-merger in the making?

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Hiya, and welcome back to The Readout. 

Today, we’re getting ready for the FDA’s upcoming decision on Moderna’s mRNA flu shot, and see both a revived fight over 340B rebates and fresh legal scrutiny for Lilly’s insulin pricing.

Continue to STAT+ to read the full story…

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Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Hiya, and welcome back to The Readout. 

Today, we’re getting ready for the FDA’s upcoming decision on Moderna’s mRNA flu shot, and see both a revived fight over 340B rebates and fresh legal scrutiny for Lilly’s insulin pricing.

Continue to STAT+ to read the full story…

Read More

Continue Reading

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BioNTech picks Sobi CEO Oelkers to lead as founders plot new mRNA biotech

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BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will take over as CEO in early 2027.

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