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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In the Spotlight

Healthcare & Life Sciences Market Update

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June 21, 2024 Podcast

Episode 82 — Drug Pricing: Takeaways From the New Orleans Pricing and Contracting USA Conference

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May 30, 2024 Webcast

US Regulators’ Joint Inquiry Into Healthcare Consolidation: Navigating the New Landscape

April 30, 2024 Client Alert

US Regulators Announce Inquiry Into Healthcare Consolidation

January 4, 2024 Article

2024 Drug Pricing Look Ahead: Federal, State Drug Pricing Plans Likely to Prompt Challenges

March 15, 2024 Article

Recent Updates on Emerging Trends in the Global Regulation of Digital Health

In the latest edition of ICLG Digital Health 2024, partners Eveline Van Keymeulen and Elizabeth Richards, counsel Nicole Liffrig Molife, and associate Oliver Mobasser discuss emerging trends in the global regulation of digital health in the US, EU, and UK, and the frameworks striving to catch up with technological advancement.

November 13, 2023 Article

Clinical Trials: Overview (France)

A practice note providing an overview of the regulation of clinical trials of medicinal products in France.

November 2, 2023 Client Alert

President Biden’s Executive Order on Artificial Intelligence — Initial Analysis of Private Sector Implications

June 21, 2024 Podcast

Episode 82 — Drug Pricing: Takeaways From the New Orleans Pricing and Contracting USA Conference

June 13, 2024 Podcast

Episode 81 — Drug Pricing: A Look Behind the Curtain of the New ASP Reporting Website and Other Data Collection Portals

June 13, 2024

Episode 81 — Drug Pricing: A Look Behind the Curtain of the New ASP Reporting Website and Other Data Collection Portals

The new ASP reporting website highlights the increasing significance of data collection portals — and yet the number of permitted users is very small. Join us as we learn from leading practitioners at Riparian how to navigate the complex web of compliance requirements.

June 21, 2024

Episode 82 — Drug Pricing: Takeaways From the New Orleans Pricing and Contracting USA Conference

One of the year’s major drug pricing conferences just concluded in New Orleans. Join the Latham team to discuss takeaways from the conference, with topics including 340B developments, state legislative activity, and IRA implementation.

May 30, 2024

US Regulators’ Joint Inquiry Into Healthcare Consolidation: Navigating the New Landscape

Latham’s healthcare enforcement and antitrust practitioners discuss how companies can navigate the complexities of healthcare consolidation and regulatory compliance. MCLE credit offered.

March 06, 2024

Next Generation of Nicotine: Center for Tobacco Products — 2024 Outlook

Latham’s FDA Regulatory lawyers discuss CTP’s 2024 agenda for tobacco and nicotine products. MCLE credit offered.

February 21, 2024

2024 FDA Outlook: Healthcare & Life Sciences

Latham’s Healthcare & Life Sciences lawyers discuss FDA’s regulatory and legislative agenda for 2024. MCLE credit offered.

February 01, 2024

Episode 71 — Drug Pricing: A Look Ahead at Trends for 2024

Listen to this “lightning round” to hear how the policy and regulatory environment will likely remain hostile for pharmaceutical manufacturers, and how to address the turbulence that lies ahead.

January 25, 2024

Episode 68 — Drug Pricing: Will Agencies Exercise March-In Rights Based on Drug Price?

A new proposal seeks to reinvigorate the Bayh-Dole Act by allowing government to consider price as a factor when electing to exercise march-in rights.

December 13, 2023

Episode 62 — Has FDA Meaningfully Changed Its Restrictions on Off-Label Communications?

New draft guidance document signals an expanded safe harbor for communicating scientific information on unapproved uses of approved medical products.

Episode 61 Drug Pricing New OIG Guidance Reaffirms the Seven Elements of Effective Compliance

December 08, 2023

Episode 61 — Drug Pricing: New OIG Guidance Reaffirms the Seven Elements of an Effective Compliance Program

Hear from Latham attorneys and a leading industry practitioner what the OIG compliance guidance means for drug manufacturers.

December 05, 2023

Common Pitfalls in Structuring Non-Dilutive Financings Using Licenses or Collaborations

Latham Healthcare & Life Sciences partners discuss alternative financing through strategic licensing and partnerships as part of the Jefferies London Healthcare Conference.

October 20, 2023

Episode 57 — Drug Pricing: What Trends Emerged From the 2023 Medicaid Drug Rebate Program Summit?

Industry stakeholders shone a light on recent agency actions as the Inflation Reduction Act’s drug price negotiations proceed.

Our Archive

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July 1, 2024 Our Work

Latham Advises on Financing for Frazier Healthcare Partners’ Completed Acquisition of BioMatrix

Multidisciplinary team represents the private credit lenders supporting the private equity firm’s acquisition of the home infusion services provider.

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July 1, 2024 Our Work

Latham & Watkins Advises on Addus HomeCare’s US$176 Million Public Offering

Multidisciplinary team represented the underwriters in the offering.

July 1, 2024 Our Work

Latham & Watkins Advises Lifecore Biomedical on Cooperation Agreement With 22NW

June 28, 2024 Our Work

Latham & Watkins Advises on Alumis IPO

June 27, 2024 Our Work

Latham Advises Coherus BioSciences in US$40 Million Divestment

June 6, 2024 Recognition

Latham Leads the Rankings in Chambers USA 2024 Guide

Firm received the most practice and individual rankings for the tenth consecutive year.

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May 28, 2024 Recognition

Litigator of the Week Runners-Up and Shout Outs — Funko and United Therapeutics

Latham lawyers honored for securing the dismissal of a securities fraud complaint brought against Funko and its former CEO and CFO, and for a win at the D.C. Circuit for United Therapeutics.

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May 1, 2024 Recognition

Twelve Latham Partners Ranked Among Top Lawyers in EMEA

MergerLinks recognized the firm’s M&A work across multiple areas including healthcare and life sciences, technology, and antitrust.

Artificial Intelligence 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 Litigation & Professional Liability Technology

The Book of Jargon® Series

Book of Jargon Healthcare & Life Sciences

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Business Combination

The Book of Jargon® – Healthcare & Life Sciences

a transaction that results in the economic and legal combination of businesses and assets of two or more entities, whether by merger, asset purchase, stock sale or otherwise.

Word of the Day®

Central Reexamination Unit (CRU)

The Book of Jargon® – Healthcare & Life Sciences

a dedicated unit within the PTO that administers Ex Parte Reexaminations. The CRU was formed in 2005 and remains largely unchanged by the AIA.

Word of the Day®

Claim Chart

The Book of Jargon® – Healthcare & Life Sciences

typically a two-column chart providing an element-by-element comparison of a Patent’s claims against an allegedly infringing product or the prior art. Invalidity Claim Charts are useful for visualizing which claim elements exist in the prior art (Invalidity Claim Chart).

Word of the Day®

Patentable Subject Matter

The Book of Jargon® – Healthcare & Life Sciences

to be patentable, a claimed Invention must: (1) be directed to a process, machine, manufacture or Composition of Matter and (2) not be directed to laws of nature, physical phenomena, abstract ideas or another judicially recognized exception. 35 U.S.C. § 101. If only part of the Patent claim is directed to such subject matter, the Supreme Court has established a two part "Alice" test to determine whether the claim is patent eligible: (1) determine which part of the claim is directed to the unpatentable subject matter and (2) determine whether the claim’s other elements "transform" the claims into a patent-eligible application.

Word of the Day®

Certification

The Book of Jargon® – Healthcare & Life Sciences

a process by which an individual, an institution, or an educational program is evaluated and recognized as meeting prescribed standards. A nongovernmental agency usually makes the Certification, with the notable exception of Medicare or Medicaid which certify a Provider or facility under public reimbursement programs. The purpose of Certification is to assure that established standards are met in order to promote ethical and safe practice of a service or profession.

Word of the Day®