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Clark Hill PLC

The Learned Concierge - July 2025, Vol. 21

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Cybersecurity & Privacy - The Monthly Rundown of All Things Cyber, Privacy,...more

Morgan Lewis

SEC Focus on the Life Sciences Industry: What to Expect and How to Prepare

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The life sciences sector remains a critical area of focus for the US Securities and Exchange Commission (SEC) under the current administration. Companies operating in the healthcare, pharmaceutical, biotechnology, and medical...more

Epstein Becker & Green

Will Colorado’s Historic AI Law Go Live in 2026? Its Fate Hangs in the Balance in 2025

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On May 17, 2024, Colorado Governor Jared Polis signed Colorado’s historic artificial intelligence (AI) consumer protection bill, SB 24-205, colloquially known as “Colorado’s AI Act” (“CAIA”), into law....more

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

3 Tips for Avoiding Having to File a Budapest Treaty Declaration When Prosecuting Patent Applications on Biological Materials

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more

Ropes & Gray LLP

Protecting Trade Secrets in FDA Submissions from FOIA Disclosure in the Wake of FDA Layoffs

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In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more

Fenwick & West LLP

SEC Expansion of Availability of Confidential Submissions of Registration Statements Could Help Life Sciences Companies Raise...

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In an attempt to facilitate capital raising, the SEC announced that it was expanding the ability of issuers to submit draft registration statements for confidential review by the staff. Historically, this procedure was mostly...more

Fenwick & West LLP

The Life Sciences IPO Market Is Off to a Solid Start in 2025

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Various biotech companies have completed or launched their IPOs so far in 2025. As of early February, five sizeable life sciences companies have priced their IPOs and one has filed to go public soon. ...more

Fenwick & West LLP

Clinical Data FAQs: How to Approach Fundraising and Investor Relations

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For publicly traded biotech companies, disclosing clinical trial data can be an exciting milestone as you build towards an exit or public offering—but disclosure is a double-edged sword....more

Fenwick & West LLP

Clinical Data FAQs: How to Prepare for Disclosure

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When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Hogan Lovells

Publicly Traded Life Sciences Companies and Artificial Intelligence: Disclosing Risk Factors

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Although the rise of artificial intelligence (AI) has created many opportunities and breakthroughs for life sciences companies in preclinical and clinical development, risks associated with the use of AI cannot be ignored....more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Cybersecurity

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Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fifth episode of When Your Life Sciences Are on the Line, where leading...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Foley Hoag LLP - Public Companies & the Law

Biotech Public Markets Finally Thawing(?): Two Massachusetts Biotechs file S-1s

In an encouraging sign that the equity capital markets may be improving for biotechnology companies, Bicara Therapeutics Inc. and Zenas Biopharma, Inc. filed S-1 registration statements yesterday, signaling their intention to...more

J.S. Held

IP and Tech: Twin Engines of Innovative Sustainability

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In the quest for a sustainable future, the United Nations’ Sustainable Development Goals (SDGs) represent goalposts, albeit lofty ones, that countries can aim for. These 17 interconnected goals address pressing global...more

Arnall Golden Gregory LLP

Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

McDermott Will & Emery

Dual Track Reboot: Five Key Considerations for Supercharging Your Life Science Company Exit

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There have been 44 initial public offerings (IPOs) listed on the US stock markets in 2024 thus far, many of which continue to trade at a premium to their initial offering price, demonstrating the strength and buoyancy of...more

Fenwick & West LLP

ESG Insights: Silicon Valley’s Largest Public Tech and Life Sciences Companies Expanded ESG Reporting in 2023

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Amidst challenges and conflicting demands from a variety of stakeholders, technology and life sciences companies have increased their voluntary disclosure regarding environmental, social and governance (ESG) concerns. Despite...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Smart & Biggar

Dexlansoprazole formulation patent invalid and not infringed by Apotex

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On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Quarles & Brady LLP

Key Considerations for Healthcare Providers Responding to Law Enforcement Requests

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Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more

Epstein Becker & Green

Warning - Transaction Delays Expected. State Notice Requirements Ahead for Health Care M&A!

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An increasing number of states are requiring advance notice of health care transactions.  These requirements may delay transactions or result in confidential information becoming accessible to the public. Effective August 1,...more

Fenwick & West LLP

Fenwick Writes Comment Letter on Notice 2023-63 on Amortization of Specified Research or Experimental Expenditures under Section...

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Following the IRS’s issuance of guidance in Notice 2023-63 regarding R&D capitalization under Section 174, a working group of several Fenwick tax group attorneys commented to the IRS and the U.S. Treasury Department on...more

Goodwin

New ISSB Sustainability Standards: A Long-awaited Milestone for Harmonising ESG-Related Disclosure

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On 26 June 2023, the International Sustainability Standards Board (“ISSB”) issued its first two sustainability standards, IFRS S1 and IFRS S2. These standards, which incorporate the recommendations of the Task Force on...more

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