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Diamyd Medical's Phase III study published in the New England Journal of Medicin...

2/2/2012 2:30 AM EST  -   Diamyd Medical
An article with the results of Diamyd Medical's European Phase III study of the antigen-based diabetes therapy Diamyd® has been published in the scientific journal the New England Journal of Medicine. The now published results were previously presented at the American Diabetes Association’s 71st Scientific Sessions in San Diego, California, USA, on June 28, 2011.
The title of the published article is “GAD65...

Diamyd presents detailed results of European Phase III study

6/28/2011 10:30 AM EST  -   Diamyd Medical
Diamyd Medical AB reports detailed results from the Company’s European Phase III study of the antigen-based diabetes therapy Diamyd®, which, as previously announced, did not meet the primary efficacy endpoint.
Today, June 28, at the “American Diabetes Association’s 71st Scientific Sessions” in San Diego, California, USA, lead investigator Dr. Johnny Ludvigsson presents the detailed results of Diamyd Medical’s...

TrialNet presents results from a study with Diamyd®

6/28/2011 2:30 AM EST  -   Diamyd Medical
Diamyd Medical AB reports that the results of a study with the Company’s antigen-based diabetes therapy Diamyd®, conducted by the research consortium Type 1 Diabetes TrialNet did not show a statistically significant effect of the study drug.
The American research consortium Type 1 Diabetes TrialNet presented their results of a Phase II study with the antigen-based diabetes therapy Diamyd® yesterday, June 27, at...

Diamyd initiates closure of US Phase III study

6/23/2011 2:30 AM EST  -   Diamyd Medical
Diamyd Medical AB reports that the Company has decided to suspend dosing in a US Phase III study with the antigen-based therapy Diamyd® and to initiate closure of the study.
Following consultation with the US Food and Drug Administration (FDA), Diamyd Medical has decided to suspend dosing in its US Phase III study, DiaPrevent, with the antigen-based therapy Diamyd®. Study closure activities will commence...

Diamyd closes European Phase III study

6/1/2011 2:31 AM EST  -   Diamyd Medical
Diamyd Medical AB reports that the Company has decided not to complete the follow-up period of a European Phase III study with the antigen-based therapy Diamyd®.
On May 9, the Company reported that its European Phase III study with the antigen based therapy Diamyd® did not meet the primary efficacy endpoint of preserving beta cell function at 15 months, as measured by meal stimulated C-peptide, although a small...

Diamyd reports initial results from European Phase III trial in patients newly d...

5/9/2011 2:30 AM EST  -   Diamyd Medical
Diamyd Medical AB reports that results from its European Phase III study with the antigen-based therapy Diamyd® did not meet the primary efficacy endpoint of preserving beta cell function at 15 months, as measured by meal stimulated C-peptide, in newly diagnosed type 1 diabetes patients.
In Diamyd Medical’s European Phase III study in recently diagnosed type 1 diabetes patients, 10 to 20 years old, the...

Quarterly Report III 09/10

7/1/2010 2:30 AM EST  -   Diamyd Medical
Third quarter report for Diamyd Medical AB (publ.), fiscal year 2009/2010

(www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker: DMYDY
Third quarter March 1, 2010 – May 31, 2010

· Group net sales for the third quarter was MSEK 1.3 (0.2)
· Loss before tax for the third quarter was MSEK -30.9 (-26.2)
· Earnings per share after dilution for the third quarter were SEK -1.1 (-1.2)

Period September 1,...

Diamyd Medical Signs Agreement for Diabetes Therapy

6/22/2010 2:30 AM EST  -   Diamyd Medical
Diamyd Medical AB has signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy.
The agreement relates to the development and world-wide commercialization of the GAD65 antigen-based therapy (Diamyd®) for the treatment and prevention of type 1 diabetes and associated conditions.
OMJPI will make an upfront...

Diamyd’s Phase III studies continue to follow plan

4/28/2010 2:31 AM EST  -   Diamyd Medical
In her comments in today’s quarterly report, Elisabeth Lindner, President and CEO of Diamyd Medical, describes the progress in the decisive Phase III studies with the Company’s lead drug candidate Diamyd®, and comments on the Company’s strategies and efforts to build a Nordic specialty pharmaceutical company.
”We have exciting times ahead of us with only one year to go before we have the results from our...

Diamyd granted Orphan Drug Designation in the US

3/23/2010 1:55 PM EST  -   Diamyd Medical
The FDA has granted Orphan Drug Designation of Diamyd Medical´s lead drug candidate Diamyd®. Orphan drugs qualify for seven years of market exclusivity from the date of US marketing approval, tax credits for clinical research and a waiver for FDA user fees.
“This is extremely good news that we finally received today”, says Elisabeth Lindner, CEO and President of Diamyd Medical. “The granted Orphan Designation...