Author Info for Morgan Lewis - As Prescribed

Michael Abernathy

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify…more

Abbreviated New Drug Application (ANDA), Federal Trade Commission (FTC), Food and Drug Administration (FDA), FTC Act, Life Sciences

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Stephen Altieri, Ph.d.

How to Develop Partner-Ready Patent Estates

For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent…more

Intellectual Property Protection, Patent Infringement, Patents, Pharmaceutical Industry, Pharmaceutical Patents

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Michael Barron

Venture Philanthropy More Important Than Ever for Rare Disease Care

Private foundations providing support, resources, and advocacy for individuals and families affected by rare diseases have played an important role for more than 30 years in the advancement of treatments for rare diseases. Much…more

Healthcare, Internal Revenue Code (IRC), Investment, IRS, Life Sciences

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Jacqueline Berman

FDA's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change in…more

Animal Testing, Biotechnology, Food and Drug Administration (FDA), Innovative Technology, Life Sciences

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Christopher Betti, Ph.d.

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As…more

Acquisitions, Artificial Intelligence, Biologics, Biosimilars, Data Protection

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Nikita Bhojani

FDA's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change in…more

Animal Testing, Biotechnology, Food and Drug Administration (FDA), Innovative Technology, Life Sciences

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Michele Buenafe

From Prohibition to Prescription: DEA Issues Proposed Rule to Reschedule Marijuana

On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). This…more

Controlled Substances Act, DEA, Department of Health and Human Services (HHS), Marijuana, Medical Marijuana

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Laurie Burlingame

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and…more

Acquisitions, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Investors, Life Sciences

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Emily Coury

How to Develop Partner-Ready Patent Estates

For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent…more

Intellectual Property Protection, Patent Infringement, Patents, Pharmaceutical Industry, Pharmaceutical Patents

See all updates »

Rebecca Dandeker

Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition for…more

Enforcement Actions, Final Rules, Food and Drug Administration (FDA), Healthcare, Labeling

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Roshni Edalur

California’s Revised Prescription Drug Price Transparency Regulations Effective April 1

Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and notice…more

Drug Pricing, Manufacturers, Pharmaceutical Industry, Prescription Drugs, Transparency

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Gregory Etzel

US Supreme Court Hears Oral Arguments in Challenge to Chevron Deference

The US Supreme Court recently debated the future of the legal precedent known as Chevron deference in two separate cases arising out of the National Marine Fisheries Service’s statutory interpretation of the Magnuson-Stevens…more

Chevron Deference, Loper Bright Enterprises v Raimondo, Magnuson-Stevens Act (MSA), National Marine Fisheries Service, Oral Argument

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J. Clayton Everett, Jr.

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify…more

Abbreviated New Drug Application (ANDA), Federal Trade Commission (FTC), Food and Drug Administration (FDA), FTC Act, Life Sciences

See all updates »

R. Brendan Fee

FTC Policy Statement on Orange Book Listings Brings More Clarity (Sort Of)

With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration…more

Competition, Federal Trade Commission (FTC), Food and Drug Administration (FDA), FTC Act, Life Sciences

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Suzanne Filippi

Prep Pitch and Connect at the JP Morgan Healthcare Conference

As the healthcare and life sciences industry gears up for the highly anticipated JP Morgan Healthcare Conference later this month, stakeholders across the sector are focusing on key trends and strategies to make the most of this…more

Acquisitions, Artificial Intelligence, Biotechnology, Healthcare, Investment

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Stephen Forster

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security implications…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Executive Orders, Food and Drug Administration (FDA), Medicaid

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Sophia Gaulkin

FDA Issues MAPP for Reviewing Color Additives and Flavors in Oral Drug Products

FDA’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) in June explaining the agency’s internal procedures for evaluating color additives and flavors in an oral drug product submitted…more

Code of Federal Regulations (CFR), Food and Drug Administration (FDA), Generic Drugs, GRAS, Life Sciences

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Luciana Griebel

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and…more

Acquisitions, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Investors, Life Sciences

See all updates »

Jacob Harper

Congress Temporarily Extends Hospice Telehealth Face-to-Face Flexibility

US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also extended…more

Health Care Providers, Hospice, Physicians, Telehealth

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Alexander Hastings

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical…more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

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Zachary Johns

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,”…more

AMG Capital Management LLC v FTC, Antitrust Violations, Biosimilars, Competition, Exclusive Licenses

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Maarika Kimbrell

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security implications…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Executive Orders, Food and Drug Administration (FDA), Medicaid

See all updates »

Rachel Lamparelli

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security implications…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Executive Orders, Food and Drug Administration (FDA), Medicaid

See all updates »

Elizabeth Lawless

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community…more

Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Health Care Providers, Life Sciences, New Guidance

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Alan Leeds

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical…more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

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William Mcenroe

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,”…more

AMG Capital Management LLC v FTC, Antitrust Violations, Biosimilars, Competition, Exclusive Licenses

See all updates »

Scott Memmott

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose…more

Enforcement Actions, False Claims Act (FCA), Health Insurance, Medicare, OIG

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Sydney Menack

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security implications…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Executive Orders, Food and Drug Administration (FDA), Medicaid

See all updates »

Benjamin Pensak

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As…more

Acquisitions, Artificial Intelligence, Biologics, Biosimilars, Data Protection

See all updates »

Kathleen Sanzo

From Prohibition to Prescription: DEA Issues Proposed Rule to Reschedule Marijuana

On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). This…more

Controlled Substances Act, DEA, Department of Health and Human Services (HHS), Marijuana, Medical Marijuana

See all updates »

Angela Silva

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration (FDA)…more

Clinical Trials, Food and Drug Administration (FDA), Life Sciences, Medical Research, Pharmaceutical Industry

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Nathan Smith

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical…more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

See all updates »

Robert Smyth, Ph.d.

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical…more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

See all updates »

Benjamin Stein

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As…more

Acquisitions, Artificial Intelligence, Biologics, Biosimilars, Data Protection

See all updates »

Tesch Leigh West

Unpackaging CMS’s HOPPS Proposed Rule and Payments for Diagnostic Radiopharmaceuticals

In what can only be characterized as a necessary but significant proposed departure from current political initiatives focused on lowering pharmaceutical drug prices, the Centers for Medicare & Medicaid Services (CMS) proposes…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Medicare, Medicare Part B, Pharmaceutical Industry

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Jonathan York

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose…more

Enforcement Actions, False Claims Act (FCA), Health Insurance, Medicare, OIG

See all updates »

Howard Young

Congress Temporarily Extends Hospice Telehealth Face-to-Face Flexibility

US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also extended…more

Health Care Providers, Hospice, Physicians, Telehealth

See all updates »

Dennie Zastrow

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,”…more

AMG Capital Management LLC v FTC, Antitrust Violations, Biosimilars, Competition, Exclusive Licenses

See all updates »

Morgan Lewis - As Prescribed

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