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27 Aug 2015, 12:51 pm
Thomas Fleming, a statistician and “trialist,” who had served on the data safety and monitoring board of the clinical trial at issue.[2] Fleming took the rather extreme view that a clinical trial that “fails” to meet its primary pre-stated end point at the conventional p-value of less than 5 percent is an abject failure and provides no demonstration of any claim of efficacy. [read post]
20 Aug 2008, 2:14 pm
See Cargill, Inc. v. [read post]
27 Jun 2014, 3:16 pm
A transcoder translates the signals received by an antenna into data that can be transmitted over the Internet. [read post]
4 Jul 2013, 5:00 am
Cornerstone Therapeutics, Inc., 2013 WL 3198153 (2d Cir. [read post]
8 Sep 2021, 7:50 am
Akebia and Otsuka (together “Akebia”) also have a HIF-PH inhibitor, vadadustat, which is in clinical trials for the treatment of CKD anaemia. [read post]
22 Aug 2011, 2:00 am
, Inc. v. [read post]
22 Aug 2011, 2:00 am
, Inc. v. [read post]
15 Aug 2013, 12:45 am
Affinity Health Plan, Inc. [read post]
12 Apr 2007, 1:33 am
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592 (1993). [read post]
14 Oct 2014, 5:29 am
Motorola, Inc., 218 F. [read post]
4 Nov 2013, 9:56 pm
For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. [read post]
1 Mar 2023, 9:29 am
Lahey Clinic Hosp., Inc., 399 F.3d 1, 18 n.19 (1st Cir. 2005) (noting that “sampling of similar claims and extrapolation from the sample is a recognized method of proof” for the United States in an affirmative case seeking recovery under a common-law theory). [read post]
2 Jun 2021, 2:55 pm
Some background: The asserted patents arise out of research conducted by inventors at a company called QuantaLife, Inc. [read post]
15 Jun 2015, 6:24 pm
She produced the documentary film “Orgasm, Inc. [read post]
12 May 2020, 2:22 am
CIRM supported our early preclinical data all the way through our late stage clinical trials. [read post]
23 Jan 2013, 1:02 am
Ass’n of the U.S., Inc. v. [read post]
23 Jan 2013, 1:02 am
Ass’n of the U.S., Inc. v. [read post]
25 Jan 2022, 8:23 am
True Wearables, Inc. [read post]
13 Jul 2010, 12:02 pm
Just a few weeks later – on February 25, 2010 – FDA approved Nycomed US Inc. [read post]
15 May 2019, 9:05 pm
The decade data review, which the authors expect will be a “reference baseline” for future years, was published by Mary Ann Liebert Inc. in an Open Access article, which permits unrestricted year. [read post]