The Biden administration has proposed to extend medical-device oversight to laboratory developed tests. But doing so could increase compliance costs for test developers and reduce patient access to widely used tests, according to Susan Van Meter, President of the American Clinical Laboratory Association. She joins Bloomberg Intelligence analyst Duane Wright on this episode of the Votes & Verdicts podcast to discuss how the FDA’s existing framework for regulating medical devices is ill-suited for LDTs, why the Biden proposal should be withdrawn and a legislative approach to modernizing oversight of all clinical lab tests, including LDTs.

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The Biden administration’s proposal to expand the Bayh-Dole march-in framework to include price as a factor in determining that a drug isn’t accessible to the public could change collaboration agreements between universities and biotech companies. But the effort is inconsistent with the legislative intent of the framework, according to Joe Allen, executive director of the Bayh-Dole Coalition. He joins Bloomberg Intelligence analysts Duane Wright and Tish Walker on this episode of the Votes & Verdicts podcast to discuss why price shouldn’t be a factor for march-in rights, and the implications for federally supported research and development if its is.

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Apple’s choices to deal with an Apple-Watch import ban, a key hearing in Arbutus v. Moderna Covid-19 patent litigation, and more trials and a critical appeal in Bayer litigation over weed-killer Roundup are important February catalysts to watch. This Bloomberg Intelligence litigation and policy outlook episode, hosted by financials litigation analyst Elliott Stein, gathered the team to discuss these and other developments. They’ll also look at this month’s court cases, including private equity firms and hedge funds’ challenge to the SEC’s private-funds rule, and Supreme Court arguments over whether states can force internet companies like Google and Meta to carry content.

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The US Supreme Court this month refused to consider Apple’s appeal in an antitrust suit challenging its App Store. In this Votes & Verdicts episode, NYU Law Professor Harry First and Bloomberg Intelligence analysts Jennifer Rie, Anurag Rana and Tamlin Bason discuss the Epic Games v. Apple litigation and other antitrust risks Apple is facing in the US and the EU. They also look at Apple’s plans for compliance with the injunction issued by the court in the Epic Games suit, and Apple’s indirect role in a Department of Justice suit against Google over search. Rana outlines how antitrust activities could affect Apple’s business.

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Bloomberg Intelligence analysts Elliott Stein and Nathan Dean hosted Veda Partners Director of Economic Policy Research Henrietta Treyz and BTIG Director of Policy Research Isaac Boltansky to discuss their views on policies, impacts and outcomes in Washington over the coming year in this episode of the BI Votes and Verdicts podcast. Their conversation ranges from the anticipated rematch between President Joe Biden and former President Donald Trump, what, if anything, Congress will do in 2024, key actions of US regulators and a debate on whether the rule known as the Basel III endgame will be finalized this year.

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The Biden administration proposes to expand the march-in framework to include price as a factor in determining that a drug isn’t accessible to the public. March-in rights allow the US government to license to another entity patents covering inventions developed with the help of taxpayer dollars and could apply to a handful of drugs. Dr. Aaron Kesselheim of the Harvard Medical School joins Bloomberg Intelligence Analysts Duane Wright and Tish Walker on this episode of the Votes and Verdicts podcast to discuss why price should be a factor for march-in rights and the implications for federally supported research and development.

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Meta faces litigation and policy risks across the EU and the US. In this episode of the Votes and Verdicts podcast, BI analysts from the tech and litigation & government teams — Jennifer Rie, Tamlin Bason and Matt Schettenhelm — give an overview of material legal issues for Meta investors to monitor.

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Proposed changes at the US Federal Trade Commission and the Department of Justice to the rules and guidelines applicable to mergers and acquisitions may have a significant impact, making filing and completing M&A more difficult, burdensome and time-consuming. BI litigation analyst Jennifer Rie is joined by Morten Skroejer, senior director for technology competition policy at the Software & Information Industry Association, to discuss the issue. They also examine potential legislation in New York that would bring big changes to its antitrust laws.

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Apple facing an import ban on its watches, a key hearing in Disney v. Florida and a Novo Nordisk claim construction hearing in a $98 billion patent suit to block Mylan’s copy of weight-loss drug Wegovy are key December catalysts to watch. This Bloomberg Intelligence litigation and policy outlook episode, hosted by financials litigation analyst Elliott Stein, gathered the team to discuss these and other catalysts. Kenvue and others have a Dec. 7 hearing to bar plaintiffs’ experts in a class action alleging Tylenol caused autism and ADHD in babies when consumed by pregnant women. DuPont and Chemours’ $1.2 billion PFAS pact with public water authorities likely gets final court approval on Dec. 14. The trial is expected to end in the DOJ’s lawsuit challenging the JetBlue-Spirit deal. We also discussed the FDIC’s special assessment of big banks to recoup $16 billion in losses due to regional bank collapses earlier this year, and how stricter federal home loan bank limits may drive up funding costs for US banks.

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Johnson & Johnson, facing tens of thousands of lawsuits over allegations its talcum powder causes cancer, has twice attempted to use bankruptcy proceedings to reach global resolution of cases, and twice has failed. Will a potential third bankruptcy attempt by its unit bear different results? 3M, which faced hundreds of thousands of lawsuits over allegedly defective earplugs, attempted and failed to use bankruptcy proceedings to address lawsuits, yet announced a settlement of over 240,000 cases in 2H. In this Votes and Verdicts podcast episode, Bloomberg Intelligence litigation analyst Holly Froum is joined by bankruptcy litigation analyst Negisa Balluku to discuss the two companies’ maneuvers, J&J’s potential third petition, bankruptcy rulings winding their way through appellate courts, potential US Supreme Court review and more.

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