Daily Compliance News: July 21, 2025, The More Reasons Not to Go to China Edition
Daily Compliance News: March 28, 2025, The Cave or Go To Trial Edition
ABA Sound Advice: Conducting Civil Rights Audits: Benefits and Best Practices
The Justice Insiders: The Administrative State is Not Your Friend - A Conversation with Professor Richard Epstein
Litigation developments: federal forum provisions
The "Compass Rose" Method for Corporate Witness Interviews
Investment Management and Private Funds Roundtable: TALF 2020 and PPP Update
Securities Litigation and Disclosure Issues
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Credit Funds: What Managers Need to Know and Practical Tips to Avoid Insider Trading Risks
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more
On July 8, 2025, Judge Nicholas Ranjan of the United States District Court for the Western District of Pennsylvania denied a motion for judgment on the pleadings, allowing a putative securities class action to proceed against...more
On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more
Plaintiffs often file securities fraud claims against pharmaceutical companies alleging that the company misled investors about clinical data, despite the US Food and Drug Administration (FDA) subsequently approving the drug...more
California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more
On June 10, 2020, the US Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative securities fraud class action against Endologix, Inc., a medical device company, on the grounds that the shareholder’s core...more
On June 10, 2020, the Ninth Circuit affirmed the dismissal of a putative securities fraud class action in a potentially significant decision for securities defendants, particularly those in the pharmaceutical, biotech and...more
Following a recent decision from the U.S. Court of Appeals for the Ninth Circuit in Khoja v. Orexigen Therapeutics, Inc., plaintiffs alleging securities fraud against companies in the pharmaceutical and life sciences sector...more
Bass, Berry & Sims attorney Chris Lazarini provided insight on case in which class plaintiffs allege certain company officers knowingly made misleading statements about a drug's potential adverse effects which, when later...more
2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more
On November 28, 2016, the First Circuit upheld the dismissal of all but one of the class action securities fraud claims against Cambridge, MA drug company, ARIAD Pharmaceuticals, Inc., reaffirming the exacting pleading...more
On March 4, 2016, the United States Court of Appeals for the Second Circuit affirmed the District Court for the Southern District of New York in Tongue v. Sanofi, No. 15-588-CV, 2016 WL 851797 (2d Cir. Mar. 4, 2016), holding...more