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Corporate Governance Pharmaceutical Industry

Health Care Compliance Association (HCCA)

Compliance Program Effectiveness: Keep it Streamlined and Strategic

KISS takes on a new meaning in this podcast: Keep it Streamlined & Strategic. Keeping it streamlined and strategic is also the topic of a session at the 2025 HCCA Compliance Institute...more

Smart & Biggar

PMPRB announces Anie Perrault as acting Chairperson and releases latest expenditure report on private drug plan costs and...

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On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more

Husch Blackwell LLP

Navigating Life Sciences Transactions: Lessons from the Field

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This post is the fifth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions. Throughout this series,...more

Goodwin

OIG Issues Two Favorable Advisory Opinions for Dental Supply Loyalty Program and Pharmaceutical Manufacturer Sponsor of Genetic...

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In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

Quarles & Brady LLP

“It’s Okay, These Products Aren’t Paid for by Medicare” – Think Again

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A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more

Jones Day

China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry

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On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more

Skadden, Arps, Slate, Meagher & Flom LLP

2025 Insights: A First Look at Trump’s Second Term

As we step into a new year, the potential shifts under a second Trump administration loom large. Our 2025 Insights publication analyzes the impacts these changes could have on both U.S. and global business environments,...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Cooley LLP on

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...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

McDermott Will & Emery

Post-Election Outlook: Issues to Watch for Pharmacy Industry Stakeholders

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The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - October 2024

Ninth Circuit Affirms Dismissal of Insider Trading Claims Against Satellite Operator Investors Based on Stock Sales After FCC Chairman Vote - In re Silver Lake Grp., LLC Sec. Litig. (9th Cir. July 24, 2024) What to...more

Womble Bond Dickinson

[Webinar] Innovation Interchange Summit: The Power Of Cross-Industry Insight - May 16th, 11:00 am - 4:00 pm ET

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Powerful ideas emerge when you look at something through a completely different lens. And when two parties come together to share those unique perspectives? That’s when the magic happens. Womble Bond Dickinson’s virtual...more

Foley Hoag LLP - White Collar Law &...

Congressional Investigations: A Review of Investigations Likely to Continue in 2024 and into the 119th Congress

This is the sixth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

BCLP

Life Sciences - ESG Holy Grail for the Life Sciences Sector

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Together with an imperative for being a responsible ethical citizen, environmental, social and governance (ESG) standards will help deliver sustainable growth that creates both commercial and societal value.  Investors are...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2023

Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more

Sheppard Mullin Richter & Hampton LLP

2023 Top-of-Mind Issues for Life Sciences Companies

Pharma and Life Sciences Investigations and Prosecutions: The First Two Years of the Biden Administration - With the two-year mark of the Biden presidency looming, the administration’s approach to prosecuting and...more

Fenwick & West Life Sciences Group

Biotech Industry at Inflection Point with ESG Initiatives

Corporate social responsibility is not a new concept, but in recent years there has been an increased focus by investors and other stakeholders regarding how companies are addressing their environmental, social and governance...more

Goodwin

Q1 2021 Earnings Roundup: Biologics and Biosimilars Update

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Below are some highlights from first quarter 2021 earnings reports recently released by biologics and biosimilars companies...more

Foley Hoag LLP - Cannabis and the Law

Ohio Prepares for Dispensary Application Round

With much of the cannabis oriented media focusing on the flurry of adult use bills and opportunities, it is easy to overlook that many states are doubling down on their medical marijuana infrastructure. For instance, over...more

Goodwin

Q4 2020 and Full Year Earnings Roundup: Biologics and Biosimilars Update

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​​​​​​​Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies...more

Goodwin

Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Goodwin on

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: ..Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13%...more

Orrick, Herrington & Sutcliffe LLP

Board Oversight of Clinical Trials During the Pendency of the COVID-19 Pandemic

COVID-19 has had far-reaching social, economic and regulatory impacts. Nearly all companies (private and public, large and small) have had reason to more frequently convene their boards of directors to review and monitor...more

Orrick, Herrington & Sutcliffe LLP

Managing and Maintaining Clinical Trial Disclosure for Publicly Traded Life Sciences Companies

One of the fastest ways to garner unwanted attention as a publicly-traded life sciences company is to be accused by either a regulator or stockholder that the company disclosed materially misleading information about the...more

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