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Bennett Jones LLP

BBHIC 2025: Key Insights From Canada’s Leading Healthcare Investment Conference

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The Bloom Burton & Co. Healthcare Investor Conference (BBHIC), held in Toronto this week, drew over 1,500 global participants to one of Canada's leading events for healthcare investment and innovation. The conference brought...more

Knobbe Martens

An Alternative for Treating Mitral Regurgitation Receives Support for Ongoing Trial

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Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left atrium and the left ventricle, doesn’t...more

Hogan Lovells

Early benefit assessment of medicinal products in Germany – first adaptions to AMNOG implementing the EU HTA Regulation

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First adaption of German AMNOG to the EU HTA Regulation: With the German Federal Ministry of Health's recent adoption of the respective ordinance in Germany (AMNutzenV), the German legislator took a first step to integrate...more

Husch Blackwell LLP

Raising Capital in a Highly Regulated Market

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For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more

Latham & Watkins LLP

Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook

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Stakeholders from across the healthcare and biopharmaceutical industry recently convened in San Francisco for the annual J.P. Morgan Healthcare Conference. In this episode of our Connected With Latham podcast series,...more

Foley & Lardner LLP

Unlocking the Future of Medicine: The Role of AI in Drug Discovery

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Since 1995, Nature Medicine has been chronicling advances in medical technology and health care. To mark the journal’s 30th anniversary, each month an issue of critical importance for the future of medicine will be...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

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The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Morgan Lewis

Healthcare and Life Sciences: Key Insights and Considerations for Stakeholders in 2025

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This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more

Jones Day

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

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The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more

Sheppard Mullin Richter & Hampton LLP

Krazati Untitled Letter: A Cautionary Tale for CFL Promotion of Accelerated Approval Drugs

On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional...more

Foley & Lardner LLP

Cancer Drugs: Deals and Licensing for Antibody-Drug Conjugates

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Antibody-drug conjugates (ADCs) are a promising class of cancer treatments with an accelerating number of U.S. Food and Drug Administration (FDA) approvals and rapidly growing market size, as discussed in previous articles in...more

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Knobbe Martens

3M Spins Off Healthcare Business Solventum

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3M recently completed the spinoff of its healthcare technology business as the new standalone public company, Solventum Corporation.  Solventum has an IP portfolio with over 7,300 patents globally....more

McGuireWoods LLP

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

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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

Alston & Bird

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

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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

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

McDermott Will & Emery

[Event] Life Sciences Dealmaking Symposium - November 9th, Boston, MA

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Please join McDermott for our highly anticipated Life Sciences Dealmaking Symposium! Now in its 12th year, the Symposium offers a unique platform for education, insight sharing, purposeful networking and strategic...more

Rothwell, Figg, Ernst & Manbeck, P.C.

[Webinar] The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape - September 27th, 2:00 pm ET

Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more

McDermott Will & Emery

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

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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

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q2 2023

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The second quarter saw significant enforcement and dealmaking in the life sciences space. The Federal Trade Commission (FTC) announced its attempt to block Amgen/Horizon, the first such challenge to a life science transaction...more

McDermott Will & Emery

[Event] 2023 J.P. Morgan Healthcare Conference - January 10th, San Francisco, CA

Come together with key decision-makers, innovators and investors from across the healthcare, life sciences and private equity (PE) industries during the year’s largest healthcare investment symposium....more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q3 2022

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The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays....more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - September 2022 #2

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Drug Pricing Reform: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022 ...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

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The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

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