Search for: "Clinical Data, Inc."
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1 Feb 2019, 5:43 am
And federal regulators have rules for clinical trials. [read post]
1 Oct 2014, 3:09 pm
Kramer chose to include or exclude data from specific clinical trials is a matter for crossexamination, not exclusion under Daubert. [read post]
9 Jul 2015, 11:42 am
Covidien Holdings, Inc., et al., 2015 U.S. [read post]
6 Mar 2017, 10:01 am
The company said in a press release that the therapy, known as AlloJoin, is already in a phase one clinical trial in China where it is showing "promising interim 3-month safety data. [read post]
2 Jul 2013, 12:09 pm
By way of background, in August 2011 Medtronic gave a $2.5 million grant to Yale Universityfor the purpose of conducting an independent review of all clinical study data that examined the effectiveness and safety of the Infuse Bone Graft product -- also known as Medtronic’s recombinant bone morphogenetic protein-2 (rhBMP-2) product -- as well as post-marketing and safety data. [read post]
6 Jun 2013, 12:15 am
However, data exclusivity only protects clinical trial data which does not prevent another competitor from conducting their own trials (at no risk of failure), which may be likely if there is a lucrative market. [read post]
4 Nov 2013, 3:04 am
On November 4, the Department of Justice announced that Johnson & Johnson and its subsidiaries, Janssen Pharmaceuticals, Inc., and Scios, Inc., had agreed to pay $2.2 billion to resolve claims originally brought by whistleblowers that the company promoted its drugs Risperdal, Invega, and Natrecor for unapproved (off-label) uses. [read post]
5 Feb 2016, 7:55 am
Zimmer, Inc., MDL No. 2272, Master Docket No. 11 C 5468, No. 12 C 6279, 2015 WL 5050214 (N.D. [read post]
20 Oct 2018, 8:50 am
After the data are collected and analyzed, the assumptions may or may not be supported. [read post]
9 Nov 2010, 11:02 am
Barr Laboratories, Inc. [read post]
20 Jul 2009, 2:00 pm
The basis for this request was stated by the defendant to be the results of a retrospective analysis of pooled clinical data that reflected a significant increased incidence of cardiovascular events in persons taking Zelnorm. [read post]
15 Sep 2010, 9:30 pm
In this NDA, the manufacturer is required to set forth information concerning the manufacturing processes and composition of the drug, and provide sufficient data generated in adequate and well-controlled clinical investigations to demonstrate that the drug is safe and effective for its specified use. [read post]
3 Jun 2016, 1:22 pm
Maciocio obtained confidential clinical and business data about other pharmaceutical firms being considered by his company for potential acquisitions and business relationships, and he used the nonpublic information to trade in their stocks. [read post]
1 Oct 2014, 3:42 pm
(Reporting by Ben Hirschler; Editing by Crispian Balmer)[Click here to see the rest of this post]Found onRelated articlesChemical at Goodyear Plant Linked to Bladder Cancer in 50 Workers (workers-compensation.blogspot.com)Medical Device Litigation: Medtronic, Inc. v. [read post]
22 Aug 2011, 4:09 am
The Executive Editor of the New England Journal of Medicine recently called the DePuy ASR hip replacement recall a “public health nightmare” and a prime example for why the FDA needs to fix the “510(k) clearance” loophole that allows the sale of certain medical devices — even implants — to be sold without any clinical data or testing. [read post]
26 Oct 2020, 8:49 am
Carlton & Harris Chiropractic, Inc. [read post]
26 Oct 2020, 8:49 am
Carlton & Harris Chiropractic, Inc. [read post]
26 Oct 2020, 8:49 am
Carlton & Harris Chiropractic, Inc. [read post]
17 Mar 2017, 1:59 pm
The SEC alleges that one of them obtained confidential clinical and business data about other pharmaceutical firms being considered by his company for potential acquisitions and business relationships, and he used the nonpublic information to trade in their stocks. [read post]
21 Nov 2019, 9:04 am
Aradigm, Inc. [read post]
