Votes & Verdicts

Bloomberg Intelligence analysts Duane Wright and Aude Gerspacher look ahead in this edition of the Votes and Verdicts podcast and talk about key policy, regulatory and litigation issues to watch in the therapeutics sector. They discuss the implementation and legal hurdles for Inflation Reduction Act (IRA) drug pricing, the outlook for Medicare’s obesity drug coverage, the 340B drug-discount program and other far-reaching industry issues.

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Merger guidelines used by the Federal Trade Commission and Department of Justice to assess the antitrust impact of transactions were updated and revised in 4Q. In this episode of the Votes and Verdicts podcast, Edelman Smithfield Managing Director Ira Gorsky joins Bloomberg Intelligence analyst Jennifer Rie to discuss the implications of several of the changes. They focus on areas of the guidelines that significantly depart from past iterations, which may raise a range of new issues for companies contemplating a transaction, and likely broaden the scope of antitrust enforcement of M&A.

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Bloomberg Intelligence analysts Elliott Stein and Nathan Dean hosted Eugene Scalia, former Secretary of Labor and current Administrative Law and Regulatory Practice Group co-chair at Gibson Dunn, to discuss lawsuits challenging government regulations. The conversation included a discussion of Chevron deference, the Basel III endgame, SEC and California climate disclosure laws and the SEC’s private funds rule.

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Cell and gene therapies are a scientific advancement that can treat previously uncurable diseases. Yet absent a national coverage and payment framework, they will remain out of reach for patients, according to Amanda Katchmar and Alan Cohen from Boston University. They join Bloomberg Intelligence analysts Duane Wright and Ann-Hunter Van Kirk on this episode of the Votes & Verdicts podcast to discuss the pipeline for cell and gene therapies and the coverage and reimbursement outlook.

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Regulatory and enforcement review of the Synopsys-Ansys and Capital One-Discover deals, finalized PFAS rules by the EPA, and the SEC’s climate disclosure rule are important March 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. In addition, Meta’s suit challenging the FTC plan to toughen terms of the social-media giant’s $5 billion 2020 settlement is teed up for a key March 1 hearing, and a ruling is likely by March 15. Danske Bank, Deutsche Bank and Standard Chartered will be in an appeals court on March 13 to argue for preserving dismissal of a suit by US servicemembers and their families alleging the banks facilitated transfers of millions of dollars to terrorists in Afghanistan. We also reviewed health-insurer earnings and the impact US elections might have on the drug-pricing provisions of the Inflation Reduction Act.

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As federal action to reschedule, legalize or otherwise regulate the marijuana trade lingers, legitimate cannabis operations in states where pot is now legal continue to face significant barriers to programs and services, largely because the federal Controlled Substances Act still outlaws the drug. Among the many hurdles encountered by these businesses are a lack of access to federal tax credits and difficulty doing regular business with banks and credit card companies. Josh Schiller, Partner at Boies, Schiller & Flexner LLP, joins BI litigation and policy analysts Justin Teresi and Nathan Dean to discuss his constitutional challenge to the Controlled Substances Act brought on behalf of Massachusetts cannabis growers, packagers and retailers — centered on the argument that Congress can’t use the Interstate Commerce Clause to interfere with what’s now an entirely intrastate trade.

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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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Antitrust trials against Google, a court ruling on Meta’s use of teen data and Pegasystems’ Nov. 15 appeal argument to reduce Appan’s $2 billion jury award are key November 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. the trial ends in the DOJ’s suit challenging the JetBlue-Spirit M&A, and Berkshire Hathaway’s energy subsidiary PacifiCorp will be in court Nov. 9 to trim its exposure in the Oregon wildfire litigation. Virtu likely files its motion by Nov. 13 to dismiss an SEC lawsuit accusing the company of failing to enforce information barriers around trade data. We await court rulings in Bayer Roundup and Peloton securities fraud litigation. We also discussed a Federal Reserve proposal to lower debit-card fees, the Basel III endgame proposal to increase bank-capital requirements and what Mike Johnson’s ascension to the House Speaker role means for a potential government shutdown this year. In health care, we looked at an FDA proposal to extend medical-device oversight to laboratory-developed tests and a proposal to exempt orphan drugs that treat more than one disease from the drug pricing provisions of the Inflation Reduction Act.

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Bloomberg Intelligence analysts Elliott Stein and Nathan Dean hosted consumer finance lawyer Alan Kaplinsky of Ballard Spahr to discuss the Consumer Financial Protection Bureau’s past, present and future. The conversation included a discussion of the CFPB’s history, its impact on consumer finance companies, how its directors over time have differed, and the pending Supreme Court case challenging the constitutionality of the agency’s funding.

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Prescription drug negotiation provisions under the Inflation Reduction Act will lower prices on high-cost drugs for the Medicare population, but will it lead to higher or lower expenses on the commercial market? Time will tell, according to Jeff Levin-Scherz, assistant professor at the Harvard T.H. Chan School of Public Health, and Population Health Leader in the Health Management Practice at WTW. Levin-Scherz joins Bloomberg Intelligence Analyst Duane Wright on this episode of the Votes and Verdicts podcast to discuss the potential spillover effects of Medicare drug prices for employers. He also shares his views on other policies that can be implemented to drive down drug prices. 

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Much has been said about companies facing the so-called nuclear verdict in personal injury cases. In this Votes and Verdicts podcast episode, Joseph Fantini, attorney and mass tort expert joins Bloomberg Intelligence litigation analyst Holly Froum to discuss some of the major mass torts facing consumer and industrial companies including Johnson & Johnson Consumer’s Tylenol-autism lawsuits, weedkiller-cancer claims against Bayer’s Monsanto and Zantac cases against GSK and other manufacturers. They review potential catalysts on the horizon, strength of cases, as well as costs and the likelihood of potential global settlements.

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A ruling by Oct. 1 in litigation challenging Medicare drug-negotiation provisions under the Inflation Reduction Act, an Oct. 3 Supreme Court argument on the CFPB’s constitutionality and the Department of Justice’s case against the JetBlue-Spirit M&A on Oct. 16 are key catalysts to watch next month. This Bloomberg Intelligence litigation and policy outlook episode of the Votes and Verdicts podcast, hosted by financials litigation analyst Elliott Stein, gathered the team to discuss these and other catalysts. Bayer faces a bellwether trial starting Oct. 5 concerning claims that Monsanto’s Roundup weedkiller causes cancer. In tech, Meta has an Oct. 17 hearing concerning its use of teens’ data. In health care, Bausch Health has an Oct. 6 hearing to stop Norwich’s bid for final FDA approval of its Xifaxan copy and a trial starts Oct. 23 in Exelixis’ bid to keep Cabometyx generics off the market. In financials, Virtu likely responds to the SEC’s Sept. 12 lawsuit, and we’re also watching the agency’s next moves on a spot bitcoin ETF. Other topics reviewed included marijuana-banking legislation, regional bank long-term debt requirements and the potential government shutdown.

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In this follow-up to a March Votes and Verdicts episode about the biggest technology-regulation questions, Bloomberg Intelligene analysts Tamlin Bason and Matt Schettenhelm tackle the issue of artificial intelligence regulation in the US and EU. BI analyst Mandeep Singh joins the podcast to outline the key business models and opportunities tied to AI, as Bason and Schettenhelm walk through how regulation is taking shape and when it’s expected to arrive. They also discuss one of the first major litigation risks for the technology: copyright suits focused on the data that AI models use for training.

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The Federal Trade Commission’s approach to merger enforcement in the pharmaceutical and biotech industry has become increasingly aggressive. In this episode of the Votes and Verdicts podcast, Goodwin Procter’s Arman Oruc, co-chair of the company’s antitrust and competition practice, and Bloomberg Intelligence biotech analyst Marc Engelsgjerd join host and BI antitrust litigation analyst Jennifer Rie for a deeper and narrower dive of the FTC’s assessment of dealmaking and the impact on the biopharma sector.

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Medicare is prohibited from covering weight loss medications, but recent data showing potential positive health effects could increase pressure on US policymakers to change the law. The cost of removing the prohibition and the potential savings in overall health spending will be important information for Congress to consider before passing any legislation, according to Bill Hoagland, senior vice president of the Bipartisan Policy Center. Hoagland joins Bloomberg Intelligence analysts Duane Wright and Michael Shah on this episode of the Votes and Verdicts podcast to discuss how legislative revenue and spending projections are developed, why they’re important and how it could influence whether Medicare will begin covering weight-loss drugs.

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A DOJ antitrust trial v. Google, next steps in the government’s drug-negotiation process under the Inflation Reduction Act and 3M’s PFAS and earplug litigation settlements are key September catalysts to watch. This Bloomberg Intelligence litigation and policy outlook episode, hosted by analyst Elliott Stein, gathered the team to discuss these and other catalysts. In tech, an appeals court decision is expected concerning whether New York can set its own broadband rates. In health care, the FTC has a trial date challenging Amgen-Horizon M&A if it doesn’t settle first. In financials, a key appeals court argument will be held in litigation over the Fannie Mae and Freddie Mac profit sweep. We also reviewed the impact of the SEC’s private-fund rule and President Biden’s executive order to curb investments in certain Chinese industries.

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Though the 2024 US elections are still over a year away, forthcoming GOP debates will provide insight on what the elections could mean for markets and policies. In this Votes and Verdicts podcast episode, James Maloney, founding member and Managing Partner of Tiger Hill Partners, a DC-based government-relations company, joins Bloomberg Intelligence Senior Policy Analyst Nathan Dean for a discussion on whether former President Donald Trump will win the nomination, how other candidates could defeat him and what it might mean for investors’ portfolios.

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DOJ’s antitrust case v. Google, new bank-capital and internet-ad rules and a 3M earplug trial appeal are key 2H 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. In tech, the Microsoft-Activision M&A will probably close, despite a possible pending FTC appeal, and SCOTUS likely takes a case that shapes internet regulation. In financials, UBS may be fined over RMBS and Credit Suisse’s Archegos failings. In crypto, Coinbase’s defense will be helped by the SEC v. Ripple ruling, and we expect a decision in Grayscale v. SEC.
In health care, DOJ v. Teva goes to trial, as does Exelixis v. MSN. CMS releases Part D drugs subject to negotiation and a drug-pricing demo is possible.

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The prescription drug negotiation provisions in the Inflation Reduction Act grant the Medicare agency significant regulatory authority to lower prices for high-expenditure drugs, but there’s a high degree of uncertainty as to how the law will impact generic and biosimilar competition, according to Craig Burton, senior vice president of the Association for Accessible Medicines. Burton joins Bloomberg Intelligence analysts Duane Wright and Letitia Walker on this episode of the Votes and Verdicts podcast to discuss the potential impact of drug-pricing negotiation provisions and the Part D redesign on research and marketing strategies for the generic and biosimilar industry. Burton also shares his views on drug shortages and key pillars for industry. 

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Litigation risks continue for manufacturers of PFAS, including 3M, DuPont, Chemours and others, despite 3M’s proposed class action settlement announced in June for $10.5-$12.5 billion and DuPont and Chemours’ deal for $1.2 billion. In this Votes and Verdicts podcast episode, leading remediation technology expert Scott Wilson of Regenesis, a global leader in environmental technology, joins Bloomberg Intelligence analyst Holly Froum to discuss risks that remain and potential impacts of anticipated PFAS regulations.

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A major legal hurdle -- the First Amendment – stands between lawmakers’ rhetoric and the reality of a TikTok ban. The app’s rocky congressional hearing in March led some Wall Street analysts to set the chances of a US ban at 80% or higher. In this episode of Votes and Verdicts, Jameel Jaffer, Executive Director of the Knight First Amendment Institute at Columbia University, and a leading US free-speech thinker, joins Bloomberg Intelligence Litigation and Policy Analyst Matt Schettenhelm to discuss why a US ban would be so difficult to impose.

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Artificial intelligence regulations, a 3M PFAS contamination trial and FTC antitrust review of Pfizer-Seagen are likely be headline topics in June. This Bloomberg Intelligence litigation and policy outlook episode, hosted by financials litigation senior analyst Elliott Stein, gathers the team to discuss these and other catalysts: Duane Wright on the debt ceiling deal and the Medicaid renewal impact on health insurers. Matt Schettenhelm on potential AI regulations and an underappreciated legal threat to Uber and Lyft in California. Holly Froum on the 3M PFAS trial and an appeal argument in Bayer Roundup litigation. Jen Rie and the antitrust implications of the Pfizer-Seagen deal and a preview of an Apple App Store antitrust class action hearing. Nathan Dean on potential restrictions on banker bonuses and Stein on the Supreme Court’s pending ruling on President Biden’s student loan forgiveness plan.

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There’s been a shift in investing behavior in the energy space, along with a challenging infrastructure environment. In this Votes and Verdicts podcast episode, Adamantine Energy Director of Sustainable Investment Katie Bays joins Bloomberg Intelligence analyst Brandon Barnes for an in-depth discussion about investing in the energy transition. Bays also talks about permitting reform, electrolyzers and the Nebraska state soft drink.

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The prescription drug negotiation provisions in the Inflation Reduction Act fulfill a long-standing policy goal for Democrats and grant the Medicare agency significant regulatory authority to lower prices for high-expenditure drugs, according to Margaux Hall, a partner in the health-care regulatory group at Ropes & Gray. Hall joins Bloomberg Intelligence analysts Duane Wright and Letitia Walker on this episode of the Votes and Verdicts podcast to discuss the potential impact of drug-pricing negotiation provisions on research and development and patient access to innovative therapies. Hall also shares her views on the possible effect for generic manufacturers and the influence of IRA pricing on non-Medicare markets.

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The current debt-ceiling talks are part of a broader effort needed by policymakers to address Washington’s fiscal climate that should include entitlement spending, according to Bill Hoagland, senior vice president for the Bipartisan Policy Center. Hoagland joins Bloomberg Intelligence analysts Duane Wright and Nathan Dean on this episode of the Votes and Verdicts podcast to discuss the debt limit, negotiations on how to raise it and how the US amassed $31 trillion in debt. Hoagland worked on Capitol Hill for 25 years for Senate Majority Leader Bill Frist and Budget Committee Chairman Pete Domenici.

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How will the prosecution of former President Donald Trump play out? What are the strengths of the indictment? What defenses can we expect? Daniel Horwitz, partner and chair of the litigation department and white-collar defense and investigation practice at McLaughlin & Stern, joins Bloomberg Intelligence analysts Elliott Stein and Nathan Dean on this episode of the Votes and Verdicts podcast to discuss the Manhattan district attorney’s prosecution of Trump. Horwitz worked in the DA’s office for about 10 years and is a seasoned white-collar defense lawyer, enabling him to offer very smart analysis of how the case will play out. Along the way, Horwitz talks about the importance of the Manhattan DA’s office and why “The Last Waltz” is one of the three albums he would want if stranded on a desert island.

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Jason Gottlieb, Partner and Chair of the digital assets practice at Morrison Cohen, discusses the future of crypto policy and law in depth with Bloomberg Intelligence analysts Elliott Stein and Nathan Dean, on this episode of the Votes and Verdicts podcast, including the paradigm shift that SEC Chair Gary Gensler is missing, and the type of legislation he’d like to see passed. Gottlieb also talks about the the securities vs. commodities classification and the Major Questions Doctrine.

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Regulation of PFAS, known as the “Forever Chemicals,” is coming fast to the US, yet huge questions remain about the potentially massive costs of regulation and what effect rules would have on the regulated community. In this Votes & Verdicts podcast, leading remediation expert Jim Claffey, Ph.D., P.E., of Brown and Caldwell, an environmental consulting and engineering firm, joins Bloomberg Intelligence analyst Holly Froum to discuss the environmental and business impact of PFAS regulation in depth.

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How should regulators address the collapse of Silicon Valley Bank and the regional bank crisis? For one, they need to change the way they look at liquidity by factoring in the amount of uninsured deposits that sit on banks’ balance sheets. That will help regulators better understand the risk of a deposit flight like the one that felled SVB, Bloomberg Intelligence’s regional banks analyst Herman Chan explains to fellow analysts and hosts Elliott Stein and Nathan Dean on this Votes and Verdicts podcast episode. Chan discusses the banking turmoil that’s followed the collapse of SVB, which he calls a “mini crisis of confidence,” his view on the future of regional banks and the policy changes that would best address regulatory gaps.

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The Federal Trade Commission’s approach to assessing the potential antitrust implications of transactions is evolving and expanding, particularly with respect to the analysis of deals that involve companies that are potential or nascent competitors. The agency has also erected hurdles that make it increasingly difficult for merging companies to navigate their way through the antitrust process and get the deal closed, TechFreedom Senior Competition Counsel Bilal Sayyed explains to Bloomberg Intelligence. In this Votes and Verdicts podcast episode, Sayyed sits down with BI antitrust analyst Jennifer Rie for an in-depth interview to discuss the FTC’s approach to assessing transactions, various initiatives it has underway that present obstacles for merging entities, as well as efforts it’s taking to ease its ability to block deals and target the conduct of large tech companies.

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Regulation of technology platforms is coming fast to the US and EU, yet huge questions remain about how and when, with heightened scrutiny of tech companies possibly becoming the norm over the coming years, according to Bloomberg Intelligence. In this Votes and Verdicts podcast episode, BI analysts Tamlin Bason and Matthew Schettenhelm tackle the biggest questions about tech regulation in the US and EU, including data-privacy plans and potential TikTok bans.

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Bloomberg Intelligence analyst Brandon Barnes hosts energy sell-side veteran Timm Schneider for a discussion of the opportunities and risks being generated by federal policymakers for energy infrastructure, including carbon capture, low-carbon fuel standards, export bans, and tax changes. Schneider tells us how traditional energy companies are finding new opportunities in the current policy environment while also discussing the one movie he would watch if stuck on a desert island.

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Bloomberg Intelligence analysts Elliott Stein and Nathan Dean host former Congressman and White House Chief of Staff Mick Mulvaney for a discussion of the future of crypto regulation, litigation challenging the CFPB’s constitutionality, the debt ceiling and ESG. Along the way, Mulvaney also talks about his favorite job in Washington and what music he would want if stranded on a desert island.

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