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Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Emery on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...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

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

McDermott Will & Emery

This Week in 340B: February 7 – 13, 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

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q3 2023

Bass, Berry & Sims PLC on

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

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senate Once Again Tries to Address Drug Pricing

Over the past several years Congress has tried to address high drug prices, with variable success  (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived Remedies from Congress Regarding...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - December 2022

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Inflation Reduction Act Implementation: On Dec. 1, 2022, the Centers for Medicare & Medicaid Services (CMS) distributed an invitation addressed to “All Drug Manufacturers” announcing that CMS “will host monthly one-hour calls...more

Haug Partners LLP

Senate Bill and FTC 6(b) Study Turn the Heat on Pharmacy Benefit Managers Amid Drug Pricing Concerns

Haug Partners LLP on

Introduction Pharmacy benefit managers (PBMs) are the healthcare system players most patients have never heard of. Yet, PBMs represent a multibillion-dollar industry that touches the majority of Americans’ lives. Known as...more

Goodwin

Bipartisan Legislation Introduced to Increase Access to Biosimilars in Medicare Plans

Goodwin on

On April 26, Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH) introduced the Star Rating for Biosimilars Act. The proposed legislation would direct the U.S. Department of Health & Human Services (HHS) to evaluate...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 4

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In Washington: The Food and Drug Administration (FDA) has authorized the use of the Pfizer vaccine for 12 - 15 years old. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest

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Welcome to the first issue of the Latham & Watkins Drug Pricing Digest. Here, Latham’s government price reporting team provides a digest of recent developments, as reported in the trade press or published directly by...more

McDonnell Boehnen Hulbert & Berghoff LLP

Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)

Demagogy is never pretty.  When coupled with a species-threatening pandemic, the propensity for the pundit class is to be susceptible to solutions that sound reasonable only to the uninformed.  To make matters worse, some of...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 4

Hogan Lovells on

In Washington: The Consumer Financial Protection Bureau (CFPB) on Monday proposed a rule ordering debt collectors to inform tenants about their rights under a federal eviction ban if they’ve been unable to pay rent during the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 3

Hogan Lovells on

In Washington: An independent advisory panel for the Centers for Disease Control and Prevention (CDC) will meet again on April 23 to resume deliberating about the use of Johnson & Johnson's coronavirus vaccine, agency...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 2

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In Washington: On April 13, the Centers for Disease Control (CDC) and Prevention and Federal Drug Administration (FDA) paused the production of the Johnson & Johnson vaccine after six women participants in the U.S. developed...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 16

Hogan Lovells on

In Washington: The White House may split a $3 trillion economic recovery proposal into two bills, The New York Times reported Monday. The proposal comes as the economy struggles through the coronavirus pandemic-caused...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 13

Hogan Lovells on

In Washington: The Internal Revenue Service (IRS) is planning to extend the tax-filing deadline to mid-May, according to two top House Democrats. A news release Wednesday from House Ways and Means Committee Chairman Richard...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 7

Hogan Lovells on

In Washington: The House is expected to take a final vote on Wednesday morning to pass the $1.9 trillion COVID-19 relief package. The House received the bill and processing papers from the Senate on Tuesday morning. After the...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: U.S. Senate to vote on relief package, an analysis of how data protection principles relate to vaccine passports...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 18

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In Washington: The Centers for Disease Control and Prevention (CDC) warned that gym users should wear masks when exercising, even if they are more than six feet apart, and gyms need to improve ventilation. A new agency report...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 8

Hogan Lovells on

In Washington: The House voted 232-197 to impeach President Trump for a second time on a charge of inciting insurrection over the Jan. 6 siege on the U.S. Capitol that left five people, including a Capitol Police officer,...more

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