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Food and Drug Administration (FDA) › Form 8-K

Dorsey & Whitney LLP

SEC Files First Reg FD Action In Years

Dorsey & Whitney LLP on

Regulation Fair Disclosure was passed in 2002 to fill what many saw as a regulatory gap – the selective disclosure of material non-public information by issuers.  Essentially the Regulation – now known as Reg FD – requires a...more

Kramer Levin Naftalis & Frankel LLP

SEC Brings Enforcement Action against TherapeuticsMD for Violations of Regulation FD

Kramer Levin Naftalis & Frankel LLP on

On Aug. 20, 2019, the Securities and Exchange Commission (SEC) announced that it had charged public pharmaceutical company TherapeuticsMD, Inc. for violations of Regulation FD and Section 13(a) of the Exchange Act related to...more

Robins Kaplan LLP

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

Cadwalader, Wickersham & Taft LLP on

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

Parker Poe Adams & Bernstein LLP

Mild, Medium or Spicy?—Unwrapping the Chipotle Investigation

Parker Poe Adams & Bernstein LLP on

Right before Thanksgiving 2015, the news was replete with discussion of outbreaks of E. coli and potential other viruses at Chipotle restaurants. Information concerning the possible danger in consuming food at the popular...more

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