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26 May 2015, 7:42 am
  Claims such as in Mills, which are at loggerheads with FDA criteria for drug development, are precisely those with the most potential for making pharmaceutical manufacturers into “sitting ducks” for litigation, in this instance litigation based on extraneous genetic factors.It may well be that the coming (and to some extent existing) revolution in genetically individualized medical therapy will require changes in how drugs are evaluated, labeled, etc., but this is a… [read post]
25 Apr 2015, 11:03 am by Schachtman
The first edition of the Reference Manual on Scientific Evidence [Manual] was published in 1994, a year after the Supreme Court delivered its opinion in Daubert. [read post]
9 Apr 2015, 5:00 am
Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9-10 (E.D.N.Y. [read post]
15 Feb 2015, 9:43 pm by Patent Docs
Ezra Ventures LLC 1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware • Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. [read post]
8 Feb 2015, 9:59 pm by Patent Docs
Novartis Pharmaceuticals Corp. et al. v. [read post]
4 Jan 2015, 9:21 pm by Patent Docs
Novartis Pharmaceuticals Corp. et al. v. [read post]
28 Dec 2014, 9:49 pm by Patent Docs
Novartis Pharmaceuticals Corp. et al. v. [read post]
22 Aug 2014, 9:22 am
Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. [read post]
21 Aug 2014, 2:44 pm
Novartis Pharmaceuticals Corp., No. 13-6266, 2014 WL 4056889 (6th Cir. [read post]
7 Aug 2014, 5:00 am
Novartis Pharmaceuticals Corp., 2014 WL 3735622 (E.D. [read post]
10 Jul 2014, 6:41 am by Schachtman
Indeed, we can see how manipulative the authors’ so-called transparency becomes in the context of evaluating causal claims in pharmaceutical approvals versus tort claims: “Very high standards of evidence are typically expected in order to infer causal relationships or to approve the marketing of new drugs. [read post]
29 Jun 2014, 9:21 pm by Patent Docs
Novartis Pharmaceuticals Corp. et al. v. [read post]