Health and Human Services Secretary Robert F. Kennedy Jr. recently revealed on a health influencer podcast that he received unproven stem cells at a clinic in Antigua for his throat condition, spasmodic dysphonia. He also suggested that he wants to give the public much broader access to such unproven therapies, which would be extremely risky.

This revelation confirms what I had suspected for months about Kennedy. It also raises new concerns about a possible upcoming wave of reckless cell therapy deregulation from this administration.

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The report found that 96% of the Part D plans and 88% of the Medicare Advantage drug plans agreed to cover at least one of the 10 available copycat drugs on their 2025 formularies. And some did not cover the brand-name version. This was a big jump in coverage from 2024, when only 64% of the Part D plans and 52% of the Medicare Advantage drug plans covered at least one biosimilar version of Humira.

Overall, 99% of enrollees in Part D Plans and 90% in Medicare Advantage drug plans had access to at least one Humira biosimilar in 2025. However, some plans are still restricting access to the biosimilars this year, which precludes usage. Specifically, 10% of Medicare Advantage drug plans and 1% of Part D plans cover only the brand-name medication.

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The meeting was with a startup created by Flatiron Health veterans Josh Haimson and Ben Birnbaum. The duo had built the first team at Flatiron focused on machine learning, and, a few years after pharmaceutical giant Roche snapped up the company for $1.9 billion, they launched their own company.

Their new venture, Inductive Bio, has created an artificial intelligence tool that biotechs can use to design and model different versions of a small-molecule drug, sussing out what variation might cause drug toxicity or be metabolized too quickly. 

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customers six years ago, but did not report any profits from those sales on its 2019 tax returns because all of the income was supposedly earned offshore, according to an investigation by the Democratic staff of the Senate Finance Committee.

As a result, the company was able to avoid paying billions of dollars in federal income taxes and, in fact, also did not report any taxable income in the U.S. for 2018 and 2020. To accomplish this, Pfizer used what was described as an “egregious tax gimmick” called “round-tripping,” a tax avoidance scheme that involves making sales to U.S. customers, but treating the profits as foreign income for tax purposes.

Often, round-tripping refers to offshoring manufacturing to a foreign subsidiary located in another country or jurisdiction with lower tax rates. The list includes Puerto Rico and Ireland, where Pfizer has various operations. Another tactic is to shift intellectual property rights to such havens or engage in transfer pricing, which involves a company selling itself products at artificially high prices.

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Good morning. Let’s get straight into the news today.

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Good morning. The MAHA movement is influencing not only the federal government, but also state legislatures across the U.S. We discuss all that and the key biotech news today.

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When it comes to delivering shareholder value through M&A, Ron Renaud is a biotech investor’s best friend. Over the last 10 years, all three of the companies he has helmed were sold to Big Pharma for a combined $16 billion. 

With that track record — and the financial windfall it brings — no one would have begrudged Renaud, 55, had he desired to spend more time with his Cape Cod fishing buddies. But he can’t quit biotech. Weeks after overseeing the close of Cerevel Therapeutics’s $8.7 billion acquisition by AbbVie, Renaud is back as CEO of Kailera Therapeutics, a newly formed company with a pipeline of weight loss drug candidates.

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Good morning. Today, we look at the biggest biotech events to watch this quarter. And as my editor had to remind me (since I’m still in denial), we are indeed in the fourth quarter now.

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Atlas, Bain, and RTW Investments announced Tuesday that they have co-led a $400 million Series A financing for a new Boston-area startup company called Kailera Therapeutics. The investors have also brought in a familiar face: Ron Renaud, who recently oversaw the $8.7 billion acquisition of Cerevel Therapeutics, a spinout of Pfizer assets that Bain helped finance back in 2018. 

Kailera’s series A round total is one of the largest in the biotech industry this year, and speaks to just how much attention weight loss medications have garnered from investors.

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Good morning. It’s another busy news day, and I’m layering up at home to avoid turning the heater on. Fall is officially here.

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