Healthcare & Life Sciences Insights

Discover Latham’s latest insights into the commercial, regulatory, and legal developments shaping the global healthcare and life sciences landscape.

Latham’s cross-disciplinary team delivers insightful, practical guidance and sophisticated representation to a full spectrum of healthcare and life sciences companies across the globe, on every type of transaction or dispute a company may face.

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August 6, 2026 Client Alert

FDA on Peptides: A New Landscape for Compounders

July 28, 2026 Client Alert

FDA Revises Draft Guidance on Demonstrating Substantial Evidence of Effectiveness

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July 1, 2026 Our Work

Latham & Watkins Advises BridgeBio on Up to US$1 Billion Preferred Equity Investment, One of the Largest Preferred Investments for Public Biotechs Ever and the Largest in 2026

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June 5, 2026 Client Alert

UK Reforms Clinical Trials Regulations

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May 13, 2026 Podcast

Drug Pricing and Market Access: CMS Update With Rujul Desai

August 10, 2026 Newsletter

Healthcare & Life Sciences: Drug Pricing Digest — Number 78

Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law.

August 6, 2026 Client Alert

FDA on Peptides: A New Landscape for Compounders

Against a backdrop of public sentiment and statements pushing rapid adoption of peptides, FDA's PCAC recommends allowing use of six peptides despite the Agency's presentations against them.

July 28, 2026 Client Alert

FDA Revises Draft Guidance on Demonstrating Substantial Evidence of Effectiveness

July 27, 2026 Newsletter

Healthcare & Life Sciences: Drug Pricing Digest — Number 77

July 14, 2026 Client Alert

FDA Proposes to Eliminate “Adequate Provision” Standard for DTC Broadcast Advertising

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June 25, 2026

Under the Spotlight: Navigating Congressional Investigations Before and After the Upcoming Midterm Elections

Latham’s bipartisan Congressional Investigations team examine the evolving landscape of congressional oversight in an election year. MCLE credit offered.

May 13, 2026

Drug Pricing and Market Access: CMS Update With Rujul Desai

Senior Counselor to CMS, Rujul Desai, joins the Latham team to share updates on a host of current policy topics, from most favored nation pricing and TrumpRx to 340B and program integrity initiatives.

May 12, 2026

DOJ Ramps Up Enforcement on Customs and Tariff Fraud: What Global Companies Need to Know to Mitigate Risk

Latham lawyers discuss what global companies need to know to mitigate risk related to DOJ’s enforcement on customs and tariff fraud. MCLE credit offered.

April 27, 2026

Drug Pricing and Market Access: Highlights From Recent CMS and AHLA Conferences

Missed the CMS Quality Conference or the AHLA Institute on Medicare and Medicaid Payment Issues? Join the Latham team for a discussion of highlights from both events.

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January 22, 2026

DOJ Enforcement Priorities: What Medical Device Companies Need to Know

Latham lawyers offer practical insights for medical device companies on mitigating enforcement risk and implementing defense strategies. MCLE credit offered.

January 16, 2026

Latham & Watkins M&A Leaders on the ‘Year of the Mega Deal’

Latham partners Alex Kelly and Paul Kukish, Global Co-Chairs of the firm’s M&A and Private Equity Practice, discuss the surge in global mega deal activity that propelled Latham to the top spot in 2025 M&A and private equity league tables and what’s shaping the deal landscape for 2026.

December 17, 2025

FDA’s QMSR Implementation Is Around the Corner: What Medical Device Companies Need to Know to Be Ready

Latham’s FDA practitioners discuss the new Quality Management System Regulation and what it means for medical device manufacturers, importers, and other stakeholders. MCLE credit offered.

December 16, 2025

Drug Pricing and Market Access: “Think of It as a Loop” — Succeeding in an Evolving Policy Landscape

Join the Latham team and guest Mike Domanico, a veteran of the pharmaceutical industry, for insights on how organizations can not only survive, but thrive in an ever-shifting policy landscape.

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December 15, 2025

Episode 106 — The FDA’s New Playbook: Biosimilars, National Priority Vouchers, and the Plausible Mechanism Pathway

The Latham team unpacks the FDA’s recent actions on the Commissioner’s National Priority Voucher program, the plausible mechanism pathway, and biosimilars — and what they could mean for development timelines, pricing, and market access.

November 24, 2025

Drug Pricing and Market Access: Government Pricing Assessment Expectations and Benefits

Join the Latham team and guest Eliza Biedziak from Ernst & Young LLP as they discuss what to expect from a government pricing assessment, the role assessments play in compliance, and how assessments can uncover strategic opportunities.

November 03, 2025

Drug Pricing and Market Access: Deep Dive on the FDA Commissioner’s National Priority Voucher Program Awards

FDA just announced nine awards under the new CNPV program, based in part on drug pricing and onshoring of manufacturing. We review the awards in detail, consider possible agency rationale, and investigate broader implications on pharmaceutical pricing, launch strategies, and market transparency.

October 02, 2025

Drug Pricing: Takeaways from the Chicago Medicaid Drug Rebate Program Summit

The largest drug pricing conference of the year just concluded in Chicago. Join the Latham team to discuss key themes and highlights, including most favored nation pricing considerations, bona fide service fee changes, and 340B program developments.

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July 30, 2025

Healthcare Implications of the One Big Beautiful Bill: What You Need to Know

Members of Latham’s Healthcare & Life Sciences Practice discuss impacts of the OBBB’s healthcare policy provisions. MCLE credit offered.

June 24, 2025

Drug Pricing: Takeaways From the Philadelphia Pricing and Contracting USA Conference

Join the Latham team and Allan Thoen from Sandoz to hear about the key themes and highlights from one of the year’s significant drug pricing conferences.

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June 26, 2025

Access Denied — Navigating the New DOJ Data Security Program With Confidence

Latham’s team of lawyers focusing on data security and national security examine DOJ’s DSP and its potential implications for companies. MCLE credit offered.

June 06, 2025

Drug Pricing: Takeaways From the MDMA Annual Meeting

One of the country’s largest medical innovation and policy conferences recently concluded in Washington, D.C. Join the Latham team to discuss takeaways from the meeting, including regulatory changes and compliance hot topics.

Our Archive

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August 17, 2026 Our Work

Latham Advises on Satellos’ US$50 Million ATM Offering

Capital Markets team represents the sales agent in the offering by the clinical‑stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases.

August 17, 2026 Our Work

Latham Advises TCGX Acquisition Corp. on Completed US$86.3 Million IPO

A Houston-based team advised the special purpose acquisition company on the transaction.

August 17, 2026 Our Work

Latham Advises Frazier Life Sciences on Private Placement Financing in Connection With Fulcrum Therapeutics and Slate Medicines Merger

August 14, 2026 Our Work

Latham Represents Zentalis Pharmaceuticals in US$80.5 Million Underwritten Public Offering

August 13, 2026 Our Work

Latham Advises on MapLight Therapeutics’ US$150 Million Private Placement Financing

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August 14, 2026 Recognition

Litigator of the Week Runners-Up and Shout-Outs — Estelgia, LLC and Netgear and Eli Lilly

Two Latham teams recognized for securing a trial win at the ITC for Estelgia, LLC and Netgear over Wi-Fi technology as well as an antitrust win for Eli Lilly involving GLP-1 medications.

August 13, 2026 Recognition

Rising Star: Latham’s Danielle McCall

White Collar Defense & Investigations partner Danielle McCall recognized as a 2026 Compliance Rising Star for advising healthcare systems, corporations, investment firms, and nonprofit organizations through high-stakes investigations, compliance challenges, and civil rights matters.

July 13, 2026 Recognition

Latham Antitrust Litigators Named to Bloomberg Law’s Unrivaled List of Top 25 Trial Lawyers

Partners Larry Buterman and Chris Yates achieved a rare calendar-year trial hat trick, successfully protecting their clients from enterprise-threatening lawsuits.

Capital Markets European Union Life Sciences Regulatory FDA Regulatory Healthcare & Life Sciences Healthcare Regulatory Intellectual Property Litigation Life Sciences Licensing Litigation & Trial Mergers & Acquisitions Private Equity Public Company Representation Securities and M&A Litigation Technology

The Book of Jargon® Series

Book of Jargon Healthcare & Life Sciences

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Average Acquisition Cost (AAC)

The Book of Jargon® – Healthcare & Life Sciences

an amount typically derived from the purchase prices retail community pharmacies pay to acquire Drug products. In the context of Medicaid, the AAC is used by some state agencies as a pricing benchmark to reimburse pharmacy Providers for covered outpatient Drugs dispensed to Medicaid beneficiaries.

Word of the Day®

Gene Therapy

The Book of Jargon® – Healthcare & Life Sciences

a generic term for modifying diseasing-causing Genes using viral Vectors, RNAi, CRISPR, antisense or zinc finger Proteins.

Word of the Day®

IPR

The Book of Jargon® – Healthcare & Life Sciences

acronym for Inter Partes Review.

Word of the Day®

Paragraph IV

The Book of Jargon® – Healthcare & Life Sciences

under the Hatch-Waxman Act, when submitting its ANDA application, a Generic Drug Manufacturer must make a Certification to the FDA about whether or not its product will infringe a valid Patent covering the branded product. A Paragraph IV Certification is one in which the applicant certifies that the Patent either is invalid or will not be infringed by the ANDA product. Paragraph IV refers to 21 U.S.C. § 355(j)(2)(A)(vii)(IV). A Paragraph IV Certification in an ANDA is considered an artificial act of patent Infringement; that is, once the generic company makes a Paragraph IV Certification, the patentee/branded drug company can sue the generic company for Infringement even though the generic company has not made, used, sold, or offered for sale an infringing Drug. Reference 35 U.S.C. § 271(e)(5).

Word of the Day®

Relator

The Book of Jargon® – Healthcare & Life Sciences

the private citizen or whistleblower who files suit under the False Claims Act on behalf of the government to assist in the prosecution of false or fraudulent conduct. After an investigatory period, the government then has the choice to either take over and prosecute the suit (typically called intervening) or to decline intervention in the case. Relators may receive a part of any recovery by the government, usually between 15-30%, plus attorney’s fees. If the government declines intervention, the relator can proceed alone as plaintiff on behalf of the government.

Word of the Day®