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Dossier in Medical News

Hard to Treat Diseases, Inc. (HTDS) Thai Registration Dossier

SHENZHEN, China, July 31 /PRNewswire-FirstCall/ - Hard to Treat Diseases, Inc. (HTDS:PK), http://www.htdsmedical.com announced today that its registration dossier for MEVAC-DTaP (Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, adsorbed) had passed the preliminary consideration ...

A Secret Dossier Predicts Major Changes At NHS, England

Government's disastrous management of the health service has been revealed by the leakage of a document, which predicts a crippling shortage of nurses, measly pay rises// and strikes. A copy of a secret Government memo on pay and workforce strategy reveals that 37000 posts are in danger as th...

FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atrial Flutter

...t setting. Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash. A registration dossier of Multaq(R) is also under regulatory review by the European Medicines Agency (EMEA). About dronedarone (Multaq (R) ) Multaq(R), discovered a...

Sinovac Reports Unaudited First Quarter 2009 Financial Results

... -- In May 2009, Sinovac filed a registration dossier for a split pandemic influenza vaccine with...ne in Hong Kong and submitted an influenza vaccine dossier to its distribution partner in India. In May, Sinovac filed a registration dossier for a split pandemic influenza vaccine with the Ch...

Johnson & Johnson to Host Analyst Conference Call To Review Six-Month Trial Results From NEVO RES I

... NEVO(TM) is the first and only drug-eluting stent utilizing a unique reservoir (RES) technology . Results from this trial will support a design dossier submission for CE Mark approval in Europe and in other countries that accept CE mark designation. Seth Fischer, Company Group Chairman, Worldwide...

Cell Therapeutics Initiating Rolling NDA Submission for Pixantrone

...ted fast track designation to submit sections of the NDA to the FDA as they become available, allowing the review process to begin before the complete dossier has been submitted. About Pixantrone Pixantrone (BBR 2778), is a novel major groove binder with an aza-anthracenedione molecular structure th...

New BSI CE-Onsite Facilitates CE Marking Reviews for Device Manufacturers

...ent feedback, BSI launches a new speed-to-market program, CE-Onsite FastTrack Review, for Class III medical devices needing European CE Marking Design dossier Reviews. This new program will expedite the review process through live, onsite interaction, facilitating more efficient communication as well as the ...

Flax Council of Canada Announces GRAS Status Determined for Flax in U.S.

...rehensive safety and toxicological assessment of flax. The industry simply did not have the resources necessary to compile the literature and submit a dossier to the FDA - until recently, and possible only through the support of Agriculture and Agri-Food Canada (AAFC). Since 2004, Flax Canada 2015 has l...

Cargill Receives Official Notification From FDA Supporting the Safety of Truvia(TM) Rebiana

...dent expert panel convened in March 2008 to review the comprehensive safety dossier for rebiana that also included safety assurance of composition and quality ...s.html ) Cargill is the only petitioner to the FDA that has made the safety dossier for rebiana publicly available as part of its GRAS notification. ...

Stallergenes Partners With Catalent and the Medical House for Commercialization of Adrenaline Autoinjector in Europe

...or food allergies, and for use by the patient himself or a relative in the event of an emergency. Catalent expects to submit the file of ADREFLEX(R) dossier for registration in Europe in 2009. Upon approval, Stallergenes will then promote and distribute the product on an exclusive basis in 13 European coun...
Dossier in Medical Technology

AMT Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera(R)

AMSTERDAM, October 3 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that it intends to incorporate additional data into the Marketing Authorization Application (MAA) for Glybera(R) for Lipoprotein Lipase ...

AMT Prepares for Submission of Marketing Authorization Dossier for AMT-011 (Glybera(R))

AMSTERDAM, June 13 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that it has concluded enrollment and treated the last patient in the pivotal trial for it's lead product AMT-011 (Glybera(R)) for Hyperlip...

HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject for Second Phase II Study

...rrent trial is part of HEALTHPOINT's ongoing development strategy for advancing wound care therapies and further enhances HEALTHPOINT's evidence-based dossier for regulatory filings in both the United States and Europe, according to Mr. Baugh. About the Study The study is a randomized, double-blind...

FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)

...fibrillation for the last twenty years. Multaq(R) has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA). About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical...

Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers

...hpoint. "The current study is an important part of our ongoing development strategy for advancing wound care therapies and our intended evidence-based dossier for regulatory filings in both the United States and Europe." About HP802-247 HP802-247 consists of two components that are sprayed sequenti...

New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation

...fibrillation for the last twenty years. Multaq(R) has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA). About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical...

Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation

...or the last twenty years. Dronedarone (Multaq(R)) has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA). About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical comp...

Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation

...ibrillation in the last twenty years. Multaq(R) has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA). About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical comp...

Further Analysis From ATHENA Study Showed That Multaq(R)(Dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation

...ibrillation in the last twenty years. Multaq(R) has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA). About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical comp...

Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation

...a safe and effective therapy where no satisfactory alternative exists compared to currently available therapies or marketed products. A registration dossier is also under regulatory review by the European Medicines Agency (EMEA) for a Marketing Authorization Application. "We are pleased that the FDA has ...
Dossier in Biological Technology

Kensey Nash Announces Agreement to Acquire Rights to OsseoFit Product

...r Device, which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions. The Company recently submitted a design dossier for CE Mark approval for its cartilage repair device; approval is expected at the end of 2009. About Kensey Nash Corporation. Kensey Nash Co...

AMT Starts Preregistration Trial for Glybera(TM)

... have been observed. AMT will include the data from the new trial in the Marketing Authorization Application for Glybera. The submission of the dossier to the European Medicines Agency is planned for the second half of 2009. About the Disease LPLD is an orphan disease, for which no treat...

AMT CEO Ronald Lorijn Steps Down

... Deventer: "I look forward to guiding AMT at this important stage with the clinical trial for Glybera(R) and the filing of the marketing authorization dossier for this product. I am focused on successfully developing our drug candidates into cures for serious diseases together with the team of excellent and ...

Arpida to Restructure and Focus on Key Projects

...situation with external experts to determine the future development of Iclaprim. Basis for this analysis will be the full FDA response to the Iclaprim dossier and the publication of the phase II oral step down therapy trial. "We were very surprised by this very clear negative ruling by the FDA adviso...

Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidance Upgrade.

...mited ("Renovo") is also intending to initiate a Phase 3 trial in the second half of 2008 in support of Renovo's filing of a European regulatory dossier and has recently announced that the European Medicines Agency ("EMEA") has given clearance to commence Phase 3 trials. Shire is considering the ...

EntreMed Announces 2008 Corporate and Clinical Program Priorities

...t 2ME2 has disease modifying or "DMARD" activity, The FDA has accepted EntreMed's IND for 2ME2 in RA, which included an extensive human safety dossier in 300 patients from the oncology studies. Panzem(R) for RA represents a safe, orally administered, small molecule alternative to current biol...

Kensey Nash Receives FDA 510(k) Clearance for New Safe-Cross(R) Vessel Wall Detection Technology

...new technology will undergo a period of user evaluations prior to broader market introduction. This new technology has also been submitted in a design dossier for CE Mark approval, expected later this year. Separately, Kensey Nash has additional improvements underway for the Safe-Cross product line, which wi...

Targanta Submits Oritavancin New Drug Application

...Phase 3 clinical trials examining the safety and efficacy of oritavancin in the treatment of cSSSI, both of which met their primary endpoints. The NDA dossier also includes data from more than 2,100 individuals and in vitro activity data on oritavancin against more than 9,000 clinical bacterial isolates, inc...

AIM-Quoted Verona Pharma Progresses Anti-Asthma Drug Studies

...halation toxicity study. The results of this study and other toxicology studies will be analysed and included in the Investigational Medicinal Product dossier (IMPD) the company plans to submit to regulatory agencies to commence clinical studies in early 2008. About Verona Pharma plc ( http://www.veronaphar...

Nitec's IND Application for Clinical Development With Lodotra Accepted by the FDA

...lowing the positive results of a European Phase III trial (CAPRA-1; Circadian Administration of Prednisone in Rheumatoid Arthritis), Nitec submitted a dossier for marketing authorization in Europe. The FDA's acceptance of the IND will now allow Nitec to start clinical development of Lodotra in the USA. A se...
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