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Life Sciences Healthcare Reform Pharmaceutical Industry

McDermott Will & Emery

Trending in Telehealth: October 21 – 28, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Emery

This Week in 340B: October 8 – 14, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

Trending in Telehealth: May 14 – May 20, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

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On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more

Bass, Berry & Sims PLC

D.C. Circuit Becomes Second Federal Appeals Court to Allow Restrictions on 340B Contract Pharmacies

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On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Polsinelli

Florida Legislative Session 2024: Health Care Highlights

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The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis....more

McDermott Will & Emery

This Week in 340B: February 27 – March 4, 2024

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

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The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

McDermott Will & Emery

This Week in 340B: February 7 – 13, 2024

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Ballard Spahr LLP

Key Takeaways From the 2024 J.P. Morgan Healthcare Conference

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Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

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The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

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On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

McDermott Will & Emery

Trending in Telehealth: November 8 – 14, 2023

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q3 2023

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After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Hogan Lovells

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

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Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Foley & Lardner LLP

Reproductive Health: Over the Counter Birth Control Pill Supported by FDA Advisory Committees

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At the May 9-10, 2023, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, U.S. Food and Drug Administration (FDA) advisers voted that the...more

Hogan Lovells

Major regulatory changes in pharmaceutical laws and regulations in Spain for 2023

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The Annual Regulatory Plan for 2023 recently released by the Spanish Government provides for important regulatory changes and developments in the area of medicinal products, including pricing and reimbursement or health...more

Polsinelli

FDA Modifies Mifepristone REMS Program, Establishes Certification Process for Pharmacies

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On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the requirement that mifepristone...more

Quarles & Brady LLP

FDA REMS Protocol Modification Provides a Pathway for Pharmacies to Dispense Mifepristone

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On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to...more

Epstein Becker & Green

Video: Health Care's Past, Present, and Future - Diagnosing Health Care Podcast

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In celebration of the 50th episode of our Diagnosing Health Care podcast, we’re looking at how the past 50 years of health law will impact health care in the next 50 years. On this episode, Epstein Becker Green attorneys...more

Quarles & Brady LLP

Hot Off the Press: Mississippi Board of Pharmacy Files Proposed Rule on Shared Pharmacy Services

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On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more

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