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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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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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STAT+: Sandoz to pay $478.5 million to settle price-fixing allegations in long-running battle with states

Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.

Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.

The agreement marks the latest settlement in a long-running battle between numerous states and many of the largest players in the generic drug industry, which were accused of fixing prices for their medicines. Previously, Glenmark Pharmaceuticals, Lannett, Bausch, Apotex, and Heritage Pharmaceuticals collectively settled lawsuits for nearly $98 million.

Continue to STAT+ to read the full story…

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Sandoz agreed to pay $478.5 million to settle allegations by dozens of states and resellers of medicines that the company engaged in a widespread conspiracy to artificially inflate and manipulate prices of generic drugs and harmed consumers by reducing competition.

Under one settlement, the company agreed to pay $400 million over seven years starting in 2027 to resolve all remaining claims by U.S. states in three pending cases and make an additional payment of about $50 million to states that settled earlier. Another $28.5 million will be paid to resolve all remaining class-action litigation brought by indirect resellers. Sandoz did not admit to any wrongdoing.

The agreement marks the latest settlement in a long-running battle between numerous states and many of the largest players in the generic drug industry, which were accused of fixing prices for their medicines. Previously, Glenmark Pharmaceuticals, Lannett, Bausch, Apotex, and Heritage Pharmaceuticals collectively settled lawsuits for nearly $98 million.

Continue to STAT+ to read the full story…

Read More

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