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Medical Devices Pharmaceutical Industry Securities and Exchange Commission (SEC)

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...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

Kramer Levin Naftalis & Frankel LLP

SEC-Mylan Settlement: The SEC Filed Suit Regarding Investigation Disclosure

On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more

Stinson - Corporate & Securities Law Blog

SEC Brings Enforcement Action for Loss Contingency Disclosure

The SEC recently settled an enforcement action against Mylan N.V., claiming Mylan failed to timely disclose to investors a possible loss relating to a nearly two-year Department of Justice  probe into whether Mylan...more

Hogan Lovells

U.S. and Brazilian Authorities Reportedly Cooperating in Investigation of Alleged Bribery and Price Fixing Related to Medical...

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In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Thomas Fox - Compliance Evangelist

Stryker FCPA Enforcement Action: Compliance Lessons For Distributors and Dealers – Part II

Over this two-part blog post series, I have been considering the Stryker Corporation 2018 Foreign Corrupt Practices Act (FCPA) enforcement action brought by the Securities and Exchange Commission (SEC)....more

Thomas Fox - Compliance Evangelist

Stryker FCPA Enforcement Action: Compliance Lessons For Distributors and Dealers – Part I

Last month, Stryker Corporation joined a rather ignominious list of recidivists under Foreign Corrupt Practices Act (FCPA) enforcement annuls....more

A&O Shearman

Medical Device Manufacturer Enters Into Second FCPA Settlement In Five Years With SEC

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On September 28, 2018, the Securities and Exchange Commission (“SEC”) announced a settlement with a Michigan-based manufacturer and distributor of medical devices, over allegations that the company had violated the books and...more

The Volkov Law Group

Stryker Suffers “Strike Two” and Settles SEC FCPA Case

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Stryker Corporation has suffered a second FCPA enforcement action, and will now bear the stigma of FCPA “recidivist.” In reaching a settlement with the SEC and agreeing to pay a $7.8 million civil penalty, Stryker will now...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in June 2018

This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more

Knobbe Martens

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

Knobbe Martens on

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

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

The Volkov Law Group

Anti-Corruption Risks and Drug and Device Companies

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For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Stinson - Corporate & Securities Law Blog

Regulation A+ Issuer Aims for NYSE MKT Listing

Myomo, Inc. has had an offering statement qualified by the SEC in which it discloses an intent to apply to list its common stock on the NYSE MKT LLC. The offering seeks to raise $15 million on a “best efforts” basis without...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2017

Arnall Golden Gregory LLP's 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 Washington, DC...more

The Volkov Law Group

The FCPA Enforcement Run Continues into 2017

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Just when we thought 2016 was over and we could all breathe a sigh of relief, DOJ and the SEC have continued to run with a string of new enforcement actions. To all of those prognosticators, paparazzi, commentators, chicken...more

The Volkov Law Group

GSK Settles SEC FCPA Case for $20 Million

The Volkov Law Group on

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

Thomas Fox - Compliance Evangelist

The Oscar Meyer Wiener Theme and Revisiting GSK in China

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

Morrison & Foerster LLP

Top Ten International Anti-Corruption Developments for June 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 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

The Volkov Law Group

Drug and Medical Device Corruption Risks in China

The Volkov Law Group on

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

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