Shanawaz v. Intellipharmaceutics Int’l Inc., No. 17-CV-5761 (JPO) (S.D.N.Y. July 30, 2020)

On July 30, 2020, Judge J. Paul Oetken of the Southern District of New York preliminarily approved a settlement in a putative shareholder class action concerning development of an OxyContin alternative, Rexista.  The parties agreed to a settlement amount of $1.6 million.

Skiadas v. Acer Therapeutics Inc., 2020 WL 3268495 (S.D.N.Y. June 16, 2020)

On June 16, 2020, Judge Gregory Woods of the Southern District of New York granted in part and denied in part a motion to dismiss an action against Acer Therapeutics Inc. and certain of its executives regarding disclosures made in offering documents prior to the Company’s submission of a New Drug Application (“NDA”) for EDSIVO, a drug that treats Vascular Ehlers-Danlos Syndrome (“vEDS”).  Plaintiff allege that when the FDA declined to approve the drug, Acer’s stock dropped.


Continue Reading S.D.N.Y. Partially Dismisses Claims Against Pharmaceutical Company, But Allows Claim Regarding Misleading Statements About Upcoming NDA for Rare Tissue Disorder To Proceed

Hou Liu v. Intercept Pharm., Inc., 2020 WL 1489831 (S.D.N.Y. Mar. 26, 2020)

On March 26, 2020, Judge Lewis A. Kaplan of the Southern District of New York granted a motion to dismiss an action against Intercept Pharmaceuticals, Inc. and certain of its executives regarding twenty-one statements made about safety, dosing, and effects of Ocaliva, a drug approved to treat patients with primary biliary cholangitis (“PBC”), a rare liver disease.  The complaint alleged that Intercept’s stock dropped after it issued a Dear Healthcare Provider Letter (the “HCP Letter”) and again after the FDA issued a drug safety communication and a corresponding safety alert on Ocaliva.


Continue Reading S.D.N.Y. Dismisses Action due to Plaintiffs’ Failure to Link Occurrences of Serious Adverse Events to Liver Disease Drug

In re Celgene Corp. Sec. Litig., 2019 WL 6909463 (D.N.J. Dec. 19, 2019)

On December 19, 2019, Judge John Michael Vazquez of the District of New Jersey partially denied a motion to dismiss a putative securities class action complaint filed against biopharmaceutical company Celgene and certain of its executives.

Plaintiff’s allegations relied heavily on purported information from former Celgene employees, consultants, and scientists, and arose out of Celgene’s statements concerning three drugs that Celgene was developing as revenue replacements for its blockbuster multiple myeloma drug, Revlimid, which has a patent set to expire in 2022.  Judge Vazquez analyzed allegations relating to each drug in turn.


Continue Reading District Court Judge Partially Dismisses Claims Against Celgene, But Allows Allegations Regarding Misleading Statements About Sales Projections and FDA Approval to Proceed

Biondolillo v. Roche Holding AG, 2019 WL 2498928 (D.N.J. June 17, 2019)

On June 17, 2019, Senior Judge Anne E. Thompson granted a motion to dismiss an action alleging that Roche Holding AG and four executives misled investors by failing to disclose a conflict of interest on the part of a study’s trial investigator.

Plaintiffs alleged that Roche’s statements regarding one of its drug trials were misleading because Roche failed to disclose that it had paid millions of dollars in consulting fees and other payments to a doctor who served as one of the trial investigators and co-authored a publication of the study.


Continue Reading District of New Jersey Dismisses Action For Failure to Allege Materiality of Non-Disclosure of a Conflict of Interest

Forman v. Meridian Bioscience, 2019 WL 2177030 (S.D. Ohio May 20, 2019)

On May 20, 2019, Judge Susan J. Dlott of the Southern District of Ohio granted plaintiff’s motion to reconsider and amend a prior order dismissing an action against Meridian Bioscience, Inc. and two of its executives.

Plaintiff brought claims under Section 10(b) of the Exchange Act and SEC Rule 10b-5, alleging that defendants had misrepresented the efficacy of, and concealed known regulatory problems with, blood lead level testing products manufactured by Meridian’s subsidiary, Magellan Diagnostics.


Continue Reading District Judge Finds Error in Previous Dismissal of Action Against Acquirer of Blood Testing Manufacturer

In re: Ocular Therapeutix, Inc. Sec. Litig. 2019 WL 1950399 (D. Mass. Apr. 30, 2019)

Judge George O’Toole of the U.S. District Court for the District of Massachusetts dismissed a putative securities class action complaint filed against a biopharmaceutical company, Ocular Therapeutix, Inc., and certain of its officers, holding that plaintiffs failed to adequately allege an actionable misstatement or omission concerning manufacturing issues related to an eye pain reliever drug.


Continue Reading D. Mass Holds Plaintiffs Failed to Plead Securities Law Violation Regarding Company’s Statements Concerning Manufacturing of Eye Drug

Nguyen v. New Link Genetics Corp., 2019 WL 591556 (S.D.N.Y. Feb. 13, 2019)

On February 13, 2019, Judge William H. Pauley, III of the Southern District of New York dismissed a proposed investor class action against New Link Genetics Corporation.

Plaintiffs’ allegations arose out of a disclosure by New Link that a Phase 3 trial of its drug candidate for patients with resected pancreatic cancer did not achieve its primary endpoint, which plaintiffs alleged triggered a 30% drop in its stock value.


Continue Reading S.D.N.Y. Dismisses Investor Suit Concerning Pancreatic Cancer Drug Study

In re Novan, Inc., 2018 WL 6732990 (M.D.N.C. Nov. 30, 2018), adopted by, No. 1:17CV999 (M.D.N.C. Jan. 28, 2019).

On January 28th, 2019, United States District Judge Catherine C. Eagles of the Middle District of North Carolina adopted a recommendation from a magistrate judge granting the defendants’ motion to dismiss a putative securities class action brought against pharmaceutical company Novan, Inc. and its officers, directors, and underwriters.

The plaintiffs alleged that defendants made false statements and omissions about the Company’s leading drug candidate in connection with an initial public offering of its stock and in the weeks subsequent to the offering.


Continue Reading District Judge Dismisses Securities Class Action Against Novan, Inc. Relating To Disclosure of FDA Recommendations About Clinical Trials

Shanawaz v. Intellipharmaceutics Int’l Inc., No. 17-CV-5761 (JPO), 2018 WL 6605426 (S.D.N.Y. Dec. 17, 2018)

On December 17, 2018, Judge J. Paul Oetken of the Southern District of New York partially denied defendants’ motion to dismiss a putative shareholder class action concerning development of an OxyContin alternative, but dismissed claims based on defendants’ non-actionable opinions.

The case, Shanawaz v. Intellipharmaceutics Int’l Inc., arose out of the disclosure by Intellipharmaceutics International Inc. that an FDA committee had found that the Company had not demonstrated that its drug candidate, Rexista, had properties that could be expected to deter abuse, and that there was not sufficient data to support inclusion of language regarding abuse-deterrent properties on the product label for the drug.


Continue Reading S.D.N.Y. Partially Dismisses Shareholder Class Action Claims Based on Pharmaceutical Company’s Nonactionable Statements of Opinion