Cerevel Therapeutics, a neuroscience biotech that AbbVie is acquiring, reported that its drug for Parkinson’s disease improved motor symptom control as an add-on therapy in a late-stage trial.

The 27-week study found that patients taking the drug, tavapadon, on top of a common Parkinson’s treatment called levodopa, experienced 1.7 hours of improvement in “on time” without dyskinesia, which is the amount of time patients function well without involuntary movements that can be brought on by levodopa. That compared to 0.6 hours of improvement among patients taking placebo and levodopa.

This difference was statistically significant and clinically meaningful, Cerevel said in a press release Thursday. There was also a statistically significant decrease in “off time,” the amount of time patients experienced symptoms. The full results will be submitted for presentation at future medical meetings.

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New biotech newsletter launching this Thursday. Don’t miss out.

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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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that KaliVir Immunotherapeutics hired James Burke as chief medical officer. Previously, he worked at CG Oncology, where he was also chief medical officer.

But all work and no play can make for a dull chief medical officer.

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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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We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, former Alnylam Pharmaceuticals CEO John Maraganore and STAT’s Matthew Herper join us to discuss the legacy of AbbVie chief executive Richard Gonzalez, who announced his retirement this week. Then, we dive into the fascinating world of fetal genome surgery, as STAT’s Megan Molteni joins us to explain the work of a scientist named Tippi MacKenzie.

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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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As a result, the researchers contend the patents may be unfairly used to preclude competition from companies that may want to market lower-cost generic products. They also suggest antitrust regulators may want to widen a probe into improperly filed patents for asthma inhalers and epinephrine injectors to include drug-and-device combination products for combating diabetes.

A total of 188 patents were examined for 10 combination products that include a delivery device and a medicine known as a GLP-1. Among the products reviewed was Eli Lilly’s Mounjaro and Novo Nordisk’s Ozempic. Patents for another Novo Nordisk treatment, Wegovy, were also reviewed since it contains the same key ingredient as Ozempic, even though it is approved only for weight loss.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that SpliceBio hired Aniz Girach as chief medical officer. Previously, he was chief medical officer at ProQR Therapeutics.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…