Connected With Latham

Stakeholders from across the healthcare industry, including members of Congress, the US Food and Drug Administration, and the Center for Medicare and Medicaid Services, recently convened in Washington D.C. for the Medical Device Manufacturers Association (MDMA) Annual Meeting. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Nate Beaton, and Bill McConagha, and associate Danny Machado share their ke...

The “Lowering Drug Prices by Once Again Putting Americans First” Executive Order addresses various FDA matters, such as importation from Canada and accelerated approval of generics and biosimilars. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Ben Haas, and Bill McConagha analyze these FDA implications, and explore how the EO overlaps with five drug pricing bills championed by Senate Judiciary Co...

Founded in 2015, Shield AI uses technology and intelligence systems to protect service members and civilians. The venture-backed unicorn’s flagship autonomy software, Hivemind, powers aircraft, drones, and other platforms to reliably support complex missions in contested environments. Latham represented Shield AI on its US$240 million strategic funding round, raising the company’s valuation to US$5.3 billion, in March 2025. In this...

The initial months of the Trump administration have been marked by a flurry of executive orders and significant activity by the Department of Government Efficiency (DOGE). The US Food and Drug Administration is a key target of these efforts. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Ben Haas and associate Danny Machado explore how FDA may be affected, particularly as it relates to novel to...

Stakeholders from across the healthcare and biopharmaceutical industry recently convened in San Francisco for the annual J.P. Morgan Healthcare Conference. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Jason B. Caron and associate Danny Machado share key takeaways from the conference, including a renewed optimism from the dealmaking world and the healthcare policy outlook under the new Trump a...

The deadline for the EU's Digital Operational Resilience Act (DORA) has arrived. This regulation applies to most financial entities operating in the EU market and impacts a broad range of third-party providers of technology-related services. In this episode of Connected with Latham, Christian McDermott and Alain Traill explore the key changes introduced by DORA, its broad territorial scope, the types of entities that will be impact...

In this episode of Connected with Latham, the final of three episodes complementing Latham’s “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025” report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss the key cross-sector trends for financial services firms in 2025. They provide their thoughts on what firms need to be thinking about in relation to the use of AI, and the continuing...

In this episode of Connected with Latham, the second of three episodes complementing Latham’s “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025” report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss the upcoming reform agenda for retail markets in 2025. They break down the difficult challenge of balancing risk-taking and growth with consumer protection, what is next for the Con...

In this episode of Connected with Latham, the first of three episodes complementing Latham’s “10 Key Focus Areas for UK-Regulated Financial Services Firms in 2025” report, London partners Rob Moulton and Nicola Higgs and counsel Becky Critchley discuss what will likely appear on the reform agenda for wholesale markets in 2025. They examine capital markets reforms, changes to the remuneration rules and SMCR, and ongoing work on repe...

In this episode of Connected With Latham, Haim Zaltzman, Global Vice Chair of Latham’s Emerging Companies & Growth Practice, sits down with BridgeBio’s Co-Founder and Chief Executive Officer Neil Kumar and Chief Financial Officer Brian Stephenson. Since 2015, BridgeBio, a commercial-stage biopharmaceutical, has maintained a mission to discover, create, test, and deliver transformative medicines to treat patients who suffer from gen...

FDA enforcement activities range from administrative actions like conducting establishment inspections and issuing warning letters to judicial enforcement through the Department of Justice, which can take the shape of civil or criminal actions. While we can expect the agency’s core activities to continue, its priorities may shift under the incoming Trump Administration. One point of emphasis might be increasing inspections at ex-US...

The Centers for Medicare & Medicaid Services (CMS) recently published its final rule to implement the Medicaid Services Investment and Accountability Act of 2019 (MSIAA). The final rule significantly deviates from the agency’s 2023 proposal, with CMS backing off from “follow the pill” best price stacking, subjecting certain vaccines to Medicaid rebates, and creating a “shame list” of high-cost Medicaid drugs, among other proposals....

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 CMS released just days before the conference.

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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, the Court established a right to a jury trial for defendants facing civil monetary p...

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, Shabir experienced the chaos and fear firsthand, as his former West Point roommate and...

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 delve into how these payers are responding to the IRA, including the new ability for ...

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 calls to action for pharmaceutical manufacturers.

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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 online data portal. In addition to these federal programs, states are also implementi...

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 invest early in the company and also at the project level, addressing the capital-intensi...