News & Analysis as of

Life Sciences Digital Health Pharmaceutical Industry

Sheppard Mullin Richter & Hampton LLP

FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...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

Orrick, Herrington & Sutcliffe LLP

The EU AI Act: Key Takeaways for Life Sciences and Digital Health Companies

This update is part of our EU AI Act Essentials Series. The European AI Act is a landmark piece of legislation that establishes the first major comprehensive framework for regulating the use of artificial intelligence,...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

McGuireWoods LLP

[Event] 20th Annual Healthcare Private Equity and Finance Conference - May 8th - 9th, Chicago, IL

McGuireWoods LLP on

Mark your calendar for the 2024 McGuireWoods Healthcare Private Equity and Finance Conference, and help us celebrate 20 years of bringing healthcare industry leaders together. This premier two-day healthcare...more

McDermott Will & Emery

FDA Clears First OTC Continuous Glucose Monitor

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On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more

Knobbe Martens

DarioHealth Acquires Digital Health Company Twill for $22.4 Million

Knobbe Martens on

(February 22, 2024) Dario health announced on February 21, 2024 that it has acquired digital health company Twill. DarioHealth Corp. is a leading digital health company, shaping how people with chronic conditions manage their...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

Fenwick & West Life Sciences Group

In 2024, the Digital Health Revolution Continues

Digital health is showing signs of life despite financial markets that seem determined to bring some of 2023’s volatility into the new year. Stocks are up and down, and bond yields are climbing. Inflation is proving stubborn,...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

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

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

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The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

Arnall Golden Gregory LLP

FDA Issues New Draft Guidance on Regulatory Considerations for Prescription Drug Use-Related Software

New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...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

Knobbe Martens

Venture Capitalist Funding in Medtech Increasing

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Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter...more

McDermott Will & Emery

[Event] HPE Europe 2023 - September 21st, London, United Kingdom

McDermott Will & Emery on

HPE Europe is back! Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q2 2023

Bass, Berry & Sims PLC on

The healthcare M&A market appears to be steadying. Although deal activity through the year appears slightly below the high-water marks for the corresponding period of 2022, deal activity is generally up from the first quarter...more

McDermott Will & Emery

[Event] BIO Bash 2023 - June 6th, Boston, MA

McDermott Will & Emery on

Get ready to party like it’s 1985 at McDermott’s totally tubular BIO Bash! It’s the hottest event of the summer, happening during the 2023 BIO International Convention. We’re talking about an outdoor shindig with the...more

McDermott Will & Emery

FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices

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Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more

Goodwin

The ABCs of DCTs: New FDA Guidance Provides Recommendations for the Conduct of Decentralized Clinical Trials

Goodwin on

On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more

BakerHostetler

FDA Issues Draft Guidance for Decentralized Clinical Trials

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On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more

Fenwick & West Life Sciences Group

New Funding Cycle for Digital Health Begins on Cautious Note

For digital health startups, the first two months of this year were a welcome departure from 2022, when high inflation and other economic challenges caused investors to press on the brakes and proceed with caution....more

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