Morgan Lewis - As Prescribed

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Firm Profile: Morgan Lewis
1701 Market Street
Philadelphia, PA 19103-2921, United States
Phone: 215.963.5000
Fax: 215.963.5001
Areas Of Practice
  • Health
Locations
Other U.S. Locations
  • California
  • D.C.
  • Delaware
  • Florida
  • Illinois
  • Massachusetts
  • New Jersey
  • New York
  • Pennsylvania
  • Texas
Other Countries
  • Belgium
  • China
  • France
  • Germany
  • Hong Kong
  • Japan
  • Kazakhstan
  • Russia
  • Singapore
  • United Arab Emirates
  • United Kingdom

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
 /  Health, International Law & Trade

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
 /  Administrative Law, Health

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
 /  Nonprofit Law, Science, Computers, & Technology, Taxation

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
 /  Health, Mergers & Acquisitions, Science, Computers, & Technology

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
 /  Administrative Law, Health

FCA Enforcement Risk Remains for Rare Disease Stakeholders

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
 /  Health

FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025

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
 /  Administrative Law, Health, Science, Computers, & Technology

Key Takeaways from the 2025 JP Morgan Healthcare Conference

Several members of our firm’s life sciences team were on the ground at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13 to 16, 2025. It was an exciting and sunny four days, during which key…more
 /  Health, Mergers & Acquisitions, Science, Computers, & Technology

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice reflects…more
 /  Administrative Law, Health, Securities Law

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
 /  Mergers & Acquisitions, Intellectual Property, Science, Computers, & Technology

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
 /  Health, Mergers & Acquisitions

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
 /  Administrative Law, Consumer Protection, Health

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

District Court Affirms Louisianas Protection of 340B Contract Pharmacy Arrangements

340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies,…more
 /  Health

Are PDABs Pushing the Limit Drug Pricing Complexities Collide with Implementation

In response to rising prescription costs and overall state-level healthcare spending, numerous states, including Maryland and Oregon, have established prescription drug affordability review boards (PDABs) to review certain…more
 /  Health
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