News & Analysis as of

Biotechnology Enforcement Actions

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 5, May 2023

Cyber Resilience Programs Falling Short on Preparing Workers for a Crisis- “At two-thirds of organizations, there is a fear that almost all employees, 95%, will not understand how to recover following a cyberattack.” ...more

Gardner Law

[Hybrid Event] Navigating the M&A Waters of FDA-Regulated Companies - May 18th, Spring Park, MN

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Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more

American Conference Institute (ACI)

[Event] 18th Annual FCPA & Anti-Corruption for the Life Sciences Industry - May 10th - 11th, New York, NY

Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more

Foley Hoag LLP

CFIUS Year in Review

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CFIUS reviewed a record number of transactions in 2021 according to its most recent annual report – and shows no signs of slowing down. High technology (including quantum computing), life sciences, and green energy...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

Mintz

Seizing Opportunity: The post-pandemic future of US life sciences M&A 2022

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As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more

Hogan Lovells

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

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On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter: Life Sciences: What's new in France? Avastin/Lucentis case: French Competition...

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On 9 September 2020, the French Competition Authority (“FCA”) issued an infringement decision sanctioning Novartis and Roche with record fines for the pharmaceutical sector in France, totaling 444 million euros, for having...more

Skadden, Arps, Slate, Meagher & Flom LLP

Hong Kong Regulatory Update - July 2020

This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more

Dechert LLP

Biotech Beware: Increased SEC Focus on COVID-Related Activities and Claims Amplifies the Enforcement Risks for the Unaware or...

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Key Takeaways - As stocks surge in reaction to news about COVID-19-related products and solutions, the SEC is actively working to protect investors from misleading statements, fraud, and even investment scams relating to the...more

Jones Day

SEC Enforcement in Financial Reporting and Disclosure: 2019 Year-End Update

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We are pleased to present our annual year-end update on financial reporting and issuer disclosure enforcement activity for 2019. This White Paper focuses on the U.S. Securities and Exchange Commission's ("SEC") enforcement...more

Skadden, Arps, Slate, Meagher & Flom LLP

Guide for Annual Reporting on Fiscal Year 2019 for Companies Listed on the Hong Kong Stock Exchange

This update provides an overview of recent developments that will affect preparation of annual results and annual reports for companies listed on The Stock Exchange of Hong Kong Limited (HKEX). In particular, it covers...more

Foley Hoag LLP - White Collar Law &...

Biotech CEO Convicted of Securities Fraud and Obstructing SEC Investigation

The chief executive of a Boston-based biotech company, Frank Reynolds, was convicted of defrauding investors and obstructing an SEC investigation. Reynolds founded the biopharma startup PixarBio Corp. in 2013 and took the...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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We’ve already considered what the arrest of Huawei’s CFO will mean for the trade war between the U.S. and China. Now let’s dig in to what that move—and a host of recent country-level rejections of Huawei’s 5G...more

Hogan Lovells

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

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On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based...more

Knobbe Martens

Theranos Charges Provide Perspective for Medical Device Companies, Biotechnology Companies, and Investors

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On March 14, 2018, the Securities and Exchange Commission (SEC) announced it filed charges against the founder and CEO of Theranos Inc., Elizabeth Holmes, and its former president, Ramesh Balwani....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Arnall Golden Gregory LLP

SEC Charges Biotech Company and Its Officers with Misleading Investors by Failing to Disclose FDA Concerns and Recommendations

On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more

Polsinelli

FDA Targets Medical Device Companies

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FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

The Volkov Law Group

Ten Required Steps To Ensure Effective Compliance Programs By Pharmaceutical And Medical Device Companies (Part III Of III)

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In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more

Brooks Pierce

Zoom! SEC Freezes Assets in a Flash

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I don’t give investment advice on this blog. And what I’m about to say is not particularized investment advice that I’m being compensated for, but I feel okay telling you this...more

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