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BioWorld - Thursday, January 1, 2026
Home » Topics » Regulatory » SEC

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Magnifying glass atop paperwork

Chinese US-listed pharma, med-tech companies gear up for PCAOB inspections

Sep. 22, 2022
By Tamra Sami
Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards.
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China and U.S. flags

China agrees to ground-leveling PCAOB inspections

Aug. 30, 2022
By Mari Serebrov
For the first time since they’ve had access to U.S. capital, biopharma and med-tech companies based in China and Hong Kong are having to comply with the same accountability standards companies in the U.S. and other countries must follow as a condition of trading on U.S. markets.
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U.S. Securities and Exchange Commission

After 12 years, SEC issues ‘pay-vs.-performance’ rule

Aug. 25, 2022
By Mari Serebrov
A dozen years after the Dodd-Frank Act was signed into U.S. law, the SEC adopted a final rule Aug. 25 implementing the law’s so-called “pay-vs.-performance” provisions related to executive compensation.
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SEC reins in Suralign for shipping orders ahead of schedule in violation of Sarbanes-Oxley

Aug. 8, 2022
By Mark McCarty
When medical device manufacturers think of U.S. federal government enforcement, the Sarbanes-Oxley Act (SOX) of 2002 might not be the first element of the statute to come to mind. However, the Securities and Exchange Commission (SEC) used SOX to snare Suralign Holdings Inc. for pushing orders to customers ahead of schedule to draw the related revenue forward, an allegation that led to restitutions and penalties amounting to nearly $3 million.
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Acquisitions fodder of US insider trading allegations

July 25, 2022
Insider trading appears to be the U.S. SEC violation du jour. The agency filed insider trading charges against 10 individuals July 25, including a former FBI trainee and his friend who made about $82,000 and $1.3 million, respectively, from illegally trading ahead of the February 2021 announcement of Merck & Co. Inc.’s $1.85 billion tender offer to acquire Pandion Therapeutics Inc.
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Enforcement action against Medifirst inches closer to closure

July 22, 2022
By Mark McCarty
Several U.S. government agencies have been involved in the enforcement action directed toward Medifirst Solutions Inc., of Freehold, N.J., including the Department of Justice, but the Securities and Exchange Commission (SEC) has had its say as well. The SEC recently announced that a final consent judgment has been entered against a former Medifirst stock promoter, although there is still no word as to the fate of the company’s former CEO.
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SEC goes after DMD consultant for insider trading

July 8, 2022
By Mari Serebrov
Another biopharma consultant got on the wrong side of the U.S. SEC for insider trading. To resolve the allegations, Hugh Lee Sweeney, a longtime consultant for Catabasis Pharmaceutical Inc., agreed to a cease-and-desist order, disgorgement of $57,931 and prejudgment interest of $2,499.71, and civil penalties of $57,931.
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U.S., China wrecking balls

Clock is ticking on China-based securities on US exchanges

May 31, 2022
By Mari Serebrov
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
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Clock is ticking on China-based securities on US exchanges

May 25, 2022
By Mari Serebrov
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
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Biopharma consultant charged with insider trading

May 24, 2022
An executive compensation consultant is facing both civil and criminal charges related to insider trading in advance of an acquisition announcement by one of his clients, Kadmon Holding Inc.
Read More
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