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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

Key Takeaways | Clinical Trial Site Management Organizations (SMOs)

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During this session, the panelists discussed the role that SMOs and dedicated clinical trial sites (Site Platforms) play within the life sciences industry, what makes them attractive to investors, and the key criteria...more

McDermott Will & Emery

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

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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

Goodwin

Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance

Goodwin on

In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform...more

McDermott Will & Emery

Trending in Telehealth: April 23 – April 29, 2024

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

ArentFox Schiff

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

ArentFox Schiff on

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

Trending in Telehealth: January 29 – February 5, 2024

McDermott Will & Emery on

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

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...more

A&O Shearman

Global M&A Insights: Deal-making predictions for 2024

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Welcome to our year-end edition of M&A Insights, where we preview some of the themes we expect to shape deal-making over the next 12 months. Continued volatility in the debt markets has resulted in another subdued year for...more

Sheppard Mullin Richter & Hampton LLP

The March on Pharmaceutical Patents?

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more

McDermott Will & Emery

European Health & Life Sciences Symposium 2023 | Key Takeaways

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200+ leading individuals in healthcare, life sciences and private equity gathered at the Shangri-La Hotel in Paris for the European Health & Life Sciences Symposium 2023 to enjoy a day packed with fireside chats, in-depth...more

McDermott Will & Emery

Trending in Telehealth: November 8 – 14, 2023

McDermott Will & Emery on

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

Fenwick & West LLP

FTC Employs New Tactic in Effort Against Drug Makers Alleged to Have Improperly Listed Patents in the FDA’s Orange Book

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On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more

McDermott Will & Emery

Trending in Telehealth: October 11 – 16, 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

Foley & Lardner LLP

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

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In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Mind Your Ps and Qs, and Your PTAs Too

Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more

White & Case LLP

Mixed Signals: US M&A FY 2022

White & Case LLP on

Although the record-breaking deal activity of 2021 spilled over into 2022, headwinds in the first quarter developed into a significant slowdown during the rest of 2022, with an expectation of continued slowness as we enter...more

Rivkin Radler LLP

[Webinar] Lunch and Learn Series: A Survey of OIG’s 2022 Advisory Opinions: What They Could Mean for Your Organization - January...

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Please join us for the first Lunch and Learn of 2023, as Geoffrey Kaiser and Jeffrey Ehrhardt present on the OIG. The program will: 1. Discuss select Advisory Opinions from last year on a variety of topics,...more

Cozen O'Connor

Cozen Cities - December 14, 2022

Cozen O'Connor on

Massachusetts’ Energy Facilities Sitting Board approved a special permit for a controversial electrical substation in East Boston. The permit allows the project to circumvent 14 final environmental permits. 84% of Boston...more

McDermott Will & Emery

HPE Europe 2022 | Key Takeaways

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Key Trends & Opportunities in Life Sciences and Healthcare Investing - The current macroeconomic environment is creating challenges for healthcare and life sciences businesses, which have been impacted hard by wage...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

Paul Hastings LLP

No Longer a ‘Nice to Have’: ESG and What it Means for Life Sciences Companies

Paul Hastings LLP on

In April 2022, the U.K. Health Secretary, Sajid Javid, announced plans to prohibit the United Kingdom’s National Health Service (“NHS”) from buying goods and services connected with forced labour or human trafficking. This...more

Latham & Watkins LLP

UK’s MHRA Publishes Response to Consultation on Future Medical Devices Regulation

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The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more

Wilson Sonsini Goodrich & Rosati

2021 Technology and Life Sciences IPO Report

Wilson Sonsini Goodrich & Rosati’s 2021 Technology and Life Sciences IPO Report presents analysis related to 179 initial public offerings and 6 direct listings completed by U.S.-based technology and life sciences companies...more

Morrison & Foerster LLP

Theranos: The Limits of the “Fake It Till You Make It” Strategy

In the case that tested the limits of the “fake it till you make it” approach to a startup business, on January 3, 2022, a jury in the U.S. District Court for the Northern District of California convicted Elizabeth Holmes,...more

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