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Welcome to the Strive To Be More Podcast! Join Human Rights Lawyer, Public Speaker and Fine Natural Hair ROCKS Founder Lavinia Latham as she shares solid advice with you about life, relationships, and personal growth. Tune in weekly for your personal dose of clarity and motivation to fuel your self-improvement journey.
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Manufacturers, government officials, and other stakeholders recently convened in Chicago for the annual Medicaid Drug Rebate Program Summit. In this episode of Connected with Latham, Washington, D.C. associate Danny Machado interviews partner Chris Schott about takeaways from the conference, including thoughts on the new Medicaid regulation that CM…
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Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies interpret ambiguous statutes when regulating the pharmaceutical industry. And in Securities & Exchange Commission v. Jarkesy,…
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In this episode of Connected with Latham, we explore the remarkable story of Shabir Kabiri, an Afghan refugee who secured asylum in the United States with the help of a Latham pro bono team. Shabir shares his harrowing journey, his time as a cadet at West Point, and the dangers he faced upon returning home. When Kabul fell to the Taliban in 2021, S…
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The US healthcare landscape is undergoing significant changes as the Centers for Medicare & Medicaid Services (CMS) continues to implement the Inflation Reduction Act (IRA). One key stakeholder group affected by the IRA drug price negotiations and Medicare Part D redesign are health insurance companies. In this episode of Connected with Latham, we …
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Current developments grabbed much of the spotlight when key industry stakeholders met in New Orleans for the Pricing and Contracting USA Conference. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and associates Danny Machado and Elisabeth Crusey share their observations from the conference, concluding with four call…
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The Centers for Medicare and Medicaid Services (CMS) recently updated its portal for Average Sales Price (ASP) reporting under Medicare Part B. Data collection portals are also essential for manufacturer compliance with the Inflation Reduction Act and for price reporting under the Medicaid Drug Rebate Program. The 340B program operates yet another …
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As the energy tech sector continues to mature, venture capital offers an increasingly a viable path to growth as emerging energy tech companies seek to disrupt the energy space, often following a fundraising and growth trajectory similar to software and AI. Energy tech provides opportunities for financial institutions and strategic partners to inve…
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Latham’s recently released 2023 Pro Bono Annual Review highlights our public service initiatives around the world, including our ongoing relationship with Trees for Life. This conservation charity is dedicated to rewilding the Scottish Highlands through the restoration of the Caledonian Forest, which supports wildlife found nowhere else in Britain.…
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Following an array of ESG-focused regulation and escalating concerns of greenwashing risks in 2023, the year ahead looks to deliver significant industry developments at a rapid pace. In the UK, the FCA's Sustainability Disclosure Requirements (SDR), investment labelling regime, and anti-greenwashing rule will take effect during 2024. The FCA also p…
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In 2023, the FCA brought more charges for fraud offences against individuals than any other year in the regulator’s history, and secured several convictions related to fraudulent investment schemes. Yet while the FCA has signaled that economic crime is on its radar, recent years have been defined by relative inactivity, as the higher burden of proo…
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The UK’s announcement of the Edinburgh Reforms in 2022 made clear the government’s intention to chart its own course in rulemaking for the UK financial services sector, and no longer prioritise equivalence with EU legislation. The UK is currently in the process of repealing and restating all retained EU legislation, which will result in divergence …
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Two new Joint Executive Directors of Enforcement and Market Oversight appointed by the FCA in 2023 will settle into their roles over the year ahead. Following a period of enforcement defined by increased investigations and a willingness to push the envelope of legal interpretation, firms will look toward the coming year to resolve which areas of fo…
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With the UK financial services regulators due to publish Policy Statements to their consultations on diversity and inclusion (D&I) this year, conduct and culture remain high on the regulators’ agenda and connect closely to their other regulatory priorities. The regulators have proposed new D&I reporting and disclosure requirements for larger financ…
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The coming year looks poised to act as a pivotal junction for the UK financial services regulators in deciding how to approach the regulation of artificial intelligence (AI), as the financial services industry sees the continued expansion of AI-related capabilities and use cases. To avoid stifling innovation, the UK government plans to take an “agi…
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Since the announcement of the Edinburgh Reforms in 2022, the UK government has made progress on an assortment of measures spanning financial services regulation, with more developments expected in 2024. Though tabled initially as an ambitious suite of reforms, many of the proposals have not been particularly radical in reality. A recent Treasury Co…
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The pressure and uncertainty of 2023 will likely continue for drug manufacturers in 2024, with the election cycle bringing added scrutiny. At the federal level, continuing implementation of the Inflation Reduction Act, including publication of the so-called negotiated prices, may be disruptive. The states, meanwhile, will likely move forward with t…
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The UK’s decision to scrap compulsory research unbundling, following the final recommendations of the Investment Research Review, marked one of the most striking developments for financial services firms in 2023. Permitting rebundling across the board with no market capitalisation threshold comes as part of a wider approach to reinvigorate UK capit…
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As part of the FCA’s continued focus on retail markets, updates to several key regimes are due to progress over the next year. In addition to further implementation of the FCA’s Consumer Duty, the government plans to present detailed proposals on modernising the consumer credit regime, develop proposals to address the “advice gap”, and bring in a n…
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The National Institute of Standards and Technology (NIST) recently published a draft guidance framework for considering the exercise of march-in rights. Under the Bayh-Dole Act, government agencies can “march in” on patents resulting from government-funded research if the patent licensee is not sufficiently developing the patented invention, based …
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Cyberattacks targeting well-resourced businesses, especially those with institutional backing, financial support, and deep insurance coverage, have become increasingly prevalent. PE portfolio companies in particular find themselves in the crosshairs of sophisticated attackers — a heightened risk that underscores the need for boards to devote attent…
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For the last three years, UK regulatory authorities have commissioned an array of reviews and consultations to address friction points in the UK’s primary markets, culminating in reforms to the listing regime scheduled to take place in 2024. In addition to simplifying listing segments, these reforms signal a shift to a more disclosure-based regime,…
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Regulatory drivers and stakeholder demands have put environmental, social, and governance (ESG) considerations at the forefront of their agendas, with PE firms adopting ESG strategies across funds, investments, due diligence, and portfolio company management. This strong focus has prompted certain stakeholders to argue that ESG factors are receivin…
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As companies feel heightened pressure from stakeholders to adopt environmental, social, and governance (ESG) measures, greenwashing allegations continue to rise in tandem. Complex regulatory environments in the US and across Europe increase the likelihood of enforcement actions and demands for leadership teams to validate their public statements an…
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Regulators in the US, EU, and UK have increasingly scrutinized non-compete and no-poach clauses in employment agreements and M&A deals. The US Federal Trade Commission proposed a rule to ban non-competes in most situations, while several US states seek to implement complete or partial non-compete bans. In Europe, the European Commission and the UK’…
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Following a number of challenges to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released a new draft guidance document addressing truthful and non-misleading communications regarding product uses not approved or cleared by the FDA. Notably, the document updates the standard for using scientific or m…
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In November, the Department of Health and Human Services’ Office of the Inspector General (OIG) issued new compliance program guidance that affirms OIG’s long-standing focus on the seven elements of an effective compliance program, first published in 2003. In this episode of Connected With Latham, partner Chris Schott and associate Danny Machado ar…
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The UK’s Competition and Markets Authority (CMA) has increasingly asserted its jurisdiction to review private equity buy-and-build transactions, including completed deals, citing competition concerns and protection against perceived threats to consumers. With regulators in the US and elsewhere voicing similar concerns, PE firms and portfolio compan…
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On March 21, 2023, the US Supreme Court ruled for Miguel Luna Perez, a Latham pro bono client, in Perez v. Sturgis. Perez, who is deaf, was repeatedly denied reasonable accommodations, including a qualified sign-language interpreter, by Sturgis Public Schools and the Sturgis Public Schools Board of Education. Lower courts had held that Perez could …
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As security interests have become increasingly important in Europe and globally, comprehensive investment control reviews are now an unavoidable element of any cross-border acquisition – with complex legal standards that vary greatly from country to country. In this episode of Connected With Latham, London private equity partner Tom Evans speaks to…
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Not surprisingly, the Inflation Reduction Act (IRA) and its impact on the pharmaceutical industry was a key topic when manufacturers, government officials, and other stakeholders convened in Chicago for the annual Medicaid Drug Rebate Program Summit. The conference’s wide-ranging agenda spotlighted key questions and trends emerging from the Centers…
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The buoyant market of 2021 and early 2022 resulted in compressed deal timelines and frenzied competition, causing many deals to be signed with fewer buyer protections and less information about target businesses. The aftermath of this M&A surge has seen a rise in post-closing discoveries of target company issues, compounded by ongoing macroeconomic…
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Startups in the insurtech sector have found increasing success in obtaining authorization from the Financial Conduct Authority (FCA). Yet the requirements to achieve such success can complicate a startup’s operations, from early pressure on resources and staffing to regulatory obligations. In this episode of Connected With Latham, partner Shing Lo …
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In a proposed rule issued earlier this summer, the Centers for Medicare & Medicaid Services (CMS) suggested expanding the scope of combining, or stacking, discounts when determining best price. Meanwhile, the Inflation Reduction Act amended the statutory best price definition to include maximum fair prices negotiated under CMS’s new Medicare price …
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As more energy and infrastructure companies commit to sustainability targets amidst the energy transition, sustainable finance options, such as green bonds, increasingly offer a viable alternative to traditional financing for projects across the globe. Still, with enhanced regulatory scrutiny, concerns of greenwashing, and ESG-related litigation, c…
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The policy conversation related to reimbursement rates for drugs has recently turned toward pricing for entire therapeutic classes, rather than assessing the value of an individual drug. Two recent developments emphasize a growing call for establishing a single payment rate for therapeutic classes: the Medicare Payment Advisory Commission’s (MedPAC…
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The Centers for Medicare & Medicaid Services (CMS) recently published its final guidance to implement the drug price negotiation provisions of the Inflation Reduction Act. While retaining the active moiety/active ingredient approach to identifying drugs subject to negotiation, CMS now will only include those products with historic or likely Part D …
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Consumer-facing companies face an increasingly complex UK regulatory landscape as multiple regulators place the spotlight on consumer rights and protections. A raft of new legislation focused on “good consumer outcomes” is set to impact businesses and PE sponsors, heightening enforcement and censure risks including fines, public sanctions, and cons…
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Amid concerns of exaggerated or misleading sustainability claims, the UK Financial Conduct Authority’s (FCA) proposal for new labelling and disclosure rules for sustainability claims has put a spotlight on a growing range of greenwashing risks. Private equity firms should evaluate the latest wave of new rules and requirements being enacted and cont…
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Global M&A deal volumes have dipped at the start of Q1 2023, yet UK-bound M&A activity is expected to be one of the year’s highlights as overseas buyers seek out attractively priced British public and private targets. Within this activity, US buyers’ deal term preferences are likely to impact private UK M&A. So transatlantic dealmakers will find it…
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As interest rates soar to the highest rates in a decade, European real estate buyers and sellers are struggling to makes economic deals — transaction volumes in Europe fell by 44% in the last year. Despite a comparatively down year in fundraising for real estate funds, some €80 billion has already been raised for real estate acquisitions, in contra…
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Widespread economic pressure — including pay, inflation, and the ongoing cost of living crisis — has increased union visibility. As the number of workers interested in union membership grows and the frequency of strikes surges in the UK and elsewhere, PE deal teams should remain mindful of the presence and role of unions in M&A. In this episode of …
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Insurtech has become a darling of both traditional players in the insurance market and disruptive fintech operations. The coming year looks to continue this trend, with companies looking to insurtech as a venue for penetrating new markets. Yet as insurtech’s attractiveness continues to grow, potential investors will need to navigate a highly regula…
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Equity and co-investment opportunities have long served as tried and tested strategies for buyout firms seeking to incentivise management and align key management interests with those of the PE sponsor. However, PE sponsors in the US have recently received credit for extending share ownership opportunities beyond key management — and in some cases,…
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Digital infrastructure has become a basic component of all economies, and growth economies in particular. For many countries in Asia, digital infrastructure will drive development as much as power and water supply – particularly in Singapore, Indonesia, Vietnam, and India, which have the potential to be serious players in the global tech industry. …
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Not long ago, the prospect of significant PE investment in the cannabis industry would have been unthinkable for many. However, recent regulatory and legal developments have created opportunities for medical cannabis businesses and legalised new non-medical cannabis applications in many jurisdictions. Buyout firms have shown significant appetite fo…
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Music deals, particularly the acquisition of rights to songs and recordings by popular music artists, remain attractive investments for PE. The continued popularity of global streaming services and the music rental economy have helped to reduce the threat of online piracy, made revenues easier to track and predict, and ensured that strong revenues …
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Undrawn revolving credit facilities (RCFs) serve as essential parachutes to private equity. They are a backup in the event of mismatches in the working capital cycle, they provide comfort for a rainy day, and they preserve swift access to deal-making when other financing sources are unavailable, or less easily accessible. The COVID-19 pandemic clea…
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Now that the US Senate has confirmed Dr. Robert Califf as Commissioner of the US Food and Drug Administration, a position he held briefly in the Obama Administration, we turn to the priorities and perspective he is likely to bring to the agency. Making big data, including from electronic health records, useful for research and sufficient to support…
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Market sentiment and the increasing importance of environmental, social, and governance (ESG) to firms’ competitiveness across the market, combined with wide-ranging and rapidly developing ESG regulatory reforms, are driving increased focus on ESG at both LP and GP levels across Europe. As a result, the market is showing demand for enhanced diligen…
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After years of garnering little attention, environmental, social, and governance (ESG) matters are now top-of-mind for institutional investors – and are beginning to drive activist campaigns. What is behind this wave of ESG activism? And what can companies do to prepare for the possibility of an ESG-driven activist campaign? In this episode of Conn…
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