News : Diamyd® vaccine

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Last patient completes the EU Phase III study of Diamyd® antigen based therapy f...

2/14/2011 2:30 AM EST  -   Diamyd Medical
The final patient has performed the last visit of the main study period in Diamyd Medical’s European Phase III study. Treatment with the antigen based therapy Diamyd® is made to investigate whether beta cell function and thereby blood sugar control can be preserved in children and adolescents with new onset type 1 diabetes. The top line results from this study are expected to be reported as planned, in late spring...

Diamyd completes screening for US Phase III study

11/10/2010 2:30 AM EST  -   Diamyd Medical
Diamyd Medical has completed the screening of patients for the US Phase III study, DiaPrevent, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age have already been enrolled in the study and have received their first injection of the antigen-based therapy Diamyd® or placebo.
"We expect to reach the enrollment target of 320 patients in the...

Diamyd on the threshold of a new era

7/1/2010 2:35 AM EST  -   Diamyd Medical
In her comments in today's quarterly report, Elisabeth Lindner, President and CEO of Diamyd Medical, notes that a new chapter has begun in the Company’s history with last week’s agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc., to develop and commercialize the Diamyd® diabetes therapy.
"We will realize the plan to bring Diamyd® to the market in the Nordic countries ourselves and have negotiated...

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...

Diamyd US Phase III study well under way

3/10/2010 2:30 AM EST  -   Diamyd Medical
Diamyd Medical announces today that one hundred study participants have been included in the ongoing US Phase III study, DiaPrevent. The global Phase III program with the company’s lead drug candidate Diamyd® has thereby enrolled more than 430 children newly diagnosed with type 1 diabetes in Europe and the USA.
One hundred patients are now enrolled in the company’s US Phase III study called DiaPrevent at 33...

Diamyd terminates liquidity provider agreement

3/4/2010 2:20 AM EST  -   Diamyd Medical
Due to increased turnover in the share Mangold Fondkommission AB will no longer act as liquidity provider in Diamyd Medical’s B-share. The current liquidity provider agreement will expire on March 5, 2010. A new liquidity provider has not been appointed.

Diamyd informs in quarterly report of the objective to file for market approval ...

1/29/2010 2:55 AM EST  -   Diamyd Medical
In her comments in today’s quarterly report Elisabeth Lindner, President and CEO of Diamyd Medical, says that the Company’s objective is to file the Diamyd® diabetes vaccine for market approval in 2011 - a goal that isn’t very far off now.
During the first quarter Diamyd Medical has reported several important events that have contributed positively to the Company’s development. The financial position has been...

First children vaccinated in Diamyd®-study in order to prevent diabetes

6/22/2009 6:02 AM EST  -   Diamyd Medical
with the diabetes vaccine Diamyd®. The purpose of the study is to investigate whether vaccination with Diamyd® may prevent or delay that children, with high risk to develop type 1 diabetes, get the disease. This is the first time ever that vaccination is tested with the purpose to prevent this chronic disease.
The children participating in the Diamyd®-study are at high risk of developing type 1 diabetes. It has...