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Brown v. Biogen Idec Inc. et al

MEMORANDUM in Support re MOTION to Dismiss The Consolidated Class Action Complaint

30 Cited authorities

  1. Securities & Exchange Commission v. First Jersey Securities, Inc.

    101 F.3d 1450 (2d Cir. 1996)   Cited 1,266 times   5 Legal Analyses
    Holding that owner-officer who collaborated in unlawful conduct of firm may be held jointly and severally liable with firm for disgorgement of unlawful gains received

  2. Greebel v. FTP Software, Inc.

    194 F.3d 185 (1st Cir. 1999)   Cited 526 times   2 Legal Analyses
    Holding plaintiffs' failure to provide information regarding sales made by insiders at times outside the class period permitted no possibility of comparison

  3. Harris v. Ivax Corp.

    182 F.3d 799 (11th Cir. 1999)   Cited 426 times   1 Legal Analyses
    Holding that where all allegedly false statements were identified as forward-looking statements and accompanied by cautionary language, "the defendant's state of mind is irrelevant"

  4. Arruda v. Sears, Roebuck Co.

    310 F.3d 13 (1st Cir. 2002)   Cited 162 times
    Holding plaintiff to this standard in a bankruptcy action

  5. Maldonado v. Dominguez

    137 F.3d 1 (1st Cir. 1998)   Cited 182 times
    Holding that there is a "strong presumption" against finding an implied right of action in a statute

  6. In re Stone Webster, Inc., Securities Litig

    414 F.3d 187 (1st Cir. 2005)   Cited 147 times   7 Legal Analyses
    Holding that forward-looking statements are not fraudulent even if later found to be inaccurate, when they are accompanied by meaningful cautionary statements identifying information that may cause results to differ materially from statements

  7. Ezra Charitable Trust v. Tyco International, Ltd.

    466 F.3d 1 (1st Cir. 2006)   Cited 78 times
    Providing standard under Fed.R.Civ.P. 12(b)

  8. In re Credit Suisse First Boston Corp.

    431 F.3d 36 (1st Cir. 2005)   Cited 52 times   1 Legal Analyses
    Finding "although [stock] ratings are based to some degree on objective facts, they ultimately convey an opinion about a stock's prospects"

  9. Royal Business Group, Inc. v. Realist, Inc.

    933 F.2d 1056 (1st Cir. 1991)   Cited 79 times
    Determining that, where plaintiff never took advantage of Rule 15 amendment as of right, despite being on notice that its claims were being challenged as insufficient, and where plaintiff never sought to reopen judgment in district court, a request to the appellate court for remand in order to amend was untimely

  10. Fitzer v. Security Dynamics Technologies, Inc.

    119 F. Supp. 2d 12 (D. Mass. 2000)   Cited 48 times
    Holding that the PSLRA's requirements were met where the plaintiff identified the source of her information as including former employees "who handled returns," or were "in the technical support department" or were "responsible for strategic planning"

  11. Rule 8 - General Rules of Pleading

    Fed. R. Civ. P. 8   Cited 163,974 times   197 Legal Analyses
    Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."

  12. Section 78u-4 - Private securities litigation

    15 U.S.C. § 78u-4   Cited 7,737 times   53 Legal Analyses
    Granting courts authority to permit discovery if necessary "to preserve evidence or to prevent undue prejudice to" a party

  13. Section 78a - Short title

    15 U.S.C. § 78a   Cited 1,743 times   40 Legal Analyses
    Emphasizing considerations of federalism in SLUSA's legislative findings

  14. Section 78u-5 - Application of safe harbor for forward-looking statements

    15 U.S.C. § 78u-5   Cited 1,305 times   22 Legal Analyses
    Listing as an exclusion from the safe harbor "forward-looking statement in connection with a going private transaction"

  15. Section 240.10b5-1 - Trading "on the basis of" material nonpublic information in insider trading cases

    17 C.F.R. § 240.10b5-1   Cited 40 times   7 Legal Analyses
    Stating that it is an affirmative defense in insider trading cases that the defendant's purchases or sales were made pursuant to a “written plan for trading securities”

  16. Section 312.32 - IND safety reporting

    21 C.F.R. § 312.32   Cited 34 times   7 Legal Analyses
    Giving FDA regulatory flexibility in demanding interim safety reports

  17. Section 312.20 - Requirement for an IND

    21 C.F.R. § 312.20   Cited 25 times   5 Legal Analyses

    (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a) . (b) A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the investigation is subject to an IND which is in effect in accordance with § 312.40 . (c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under § 50.24 of this chapter. Such a clinical

  18. Section 312.50 - General responsibilities of sponsors

    21 C.F.R. § 312.50   Cited 14 times   4 Legal Analyses
    Concerning the content and format of NDAs

  19. Section 312.22 - General principles of the IND submission

    21 C.F.R. § 312.22   Cited 3 times   2 Legal Analyses

    (a) FDA's primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safety. Therefore, although FDA's review of Phase 1 submissions will focus on assessing the safety of Phase 1 investigations, FDA's review of Phases 2 and 3 submissions will also include an assessment of the

  20. Section 601.40 - Scope

    21 C.F.R. § 601.40   3 Legal Analyses

    This subpart applies to certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy). 21 C.F.R. § 601.40