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Hello, everyone. Damian here with a look at a pivotal FDA approval, good news for a small biotech company, and why not all buyouts are worth writing home about.

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On Thursday night, President Biden proposed expanding one of his most popular policies: the Medicare price negotiation process that was put in place as part of the Inflation Reduction Act. “Americans pay more for prescription drugs than anywhere else,” Biden said. “It’s wrong and I’m ending it.”

Obviously, the drug industry is not going to be happy about new price limitations in the U.S., the biggest market for pharmaceuticals. But, even more than that, Biden’s move emphasizes a painful reality: That pharmaceutical companies remain one of the biggest political targets in the country — despite their key role in addressing the Covid-19 pandemic and their development of wildly effective new weight loss drugs.

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Hello! Today, we discuss how the FDA is holding firm in how it handles non-compliant trial sponsors and investigators, how PhRMA is rebuilding its ranks, and offer up a fabulous podcast.

The need-to-know this morning

• Advisers to the European Medicines Agency recommended the approval of Qalsody, a treatment for ALS from Biogen.

What do CEOs owe the world?

Did Humira break the system? And can you CRISPR a fetus? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

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Gonzalez had previously said he would depart when AbbVie had a plan in place to move on from its best-selling drug, Humira, which is now facing competition from cheaper biosimilars.

He will be replaced by Chief Operating Officer Robert Michael, who, like Gonzalez, is a longtime AbbVie executive. Gonzalez, 70, will become executive chairman of the board of directors.

Gonzalez should be a sobering reminder to the drug industry’s critics of how resilient a CEO’s reputation can be. Because while he has been a subject of nearly constant criticism for AbbVie’s handling of Humira and the patents protecting it, investors are likely to remember him fondly.

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This year’s selection is so deservingly obvious that I won’t fabricate suspense by starting with an honor roll of runners-up. More on those high-achieving folks later. Let’s get right to the main course: David Ricks of Eli Lilly is the runaway, rock star, who-else-could-it-be Best Biopharma CEO of 2023.

What an incredible year it’s been for Ricks and the Lilly executive team who helped him achieve so much. My colleague Matt Herper wrote earlier this year about the “dynamic duo” of Ricks and Chief Scientific Officer Dan Skovronsky.

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Hello from ASH! Writing this Readout from a press room at the annual hematology confab here in San Diego. Today’s edition is chockfull of Vertex content, plus some extras from ASH and elsewhere.

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Good morning, everyone. Damian here with another multibillion-dollar deal, a word on the future of Sanofi, and a setback in one of medicine’s longest-running quests.

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The deal marks the second billion-dollar acquisition by AbbVie in under a week. Facing the prospect of declining sales from two of its best-selling drugs, the company also acquired Immunogen and its ovarian cancer treatment for $10 billion last Thursday.

With the buyout, AbbVie will acquire several clinical-stage molecules for Parkinson’s, schizophrenia, and epilepsy, among other disorders, many of which previously belonged to one of the company’s biggest rivals.

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Hello, everyone. Damian here with a rebound for biotech stocks, the potential of Wegovy, and a major change at the FDA.

The need-to-know this morning

• Abbvie said it would acquire ImmunoGen, a maker of cancer drugs, for $10.1 billion. ImmunoGen is being acquired for $31.26 per share, or a 95% premium to its Wednesday closing price. The company markets an antibody-drug conjugate called Elahere used to treat ovarian cancer.

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Under the agreement, AbbVie will pay $31.26 per share in cash for Immunogen, a nearly 100% premium to the company’s recent trading price. Central to the deal, expected to close in the middle of next year, is Elahere, an Immunogen product that won Food and Drug Administration approval for advanced ovarian cancer in 2022.

Elahere is among a surging class of cancer medicines called antibody-drug conjugates, or ADCs, which are designed to deliver a targeted dose of chemotherapy directly to tumor cells while sparing healthy tissues. AbbVie’s acquisition is the latest multibillion-dollar deal in the space, following Merck’s $22 billion agreement with ADC specialist Daiichi Sankyo and Pfizer’s $43 billion buyout of Seagen earlier this year.

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