FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity
26th October 2009 DUBLIN, October 26 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that the Food and Drug Administration
(FDA), following a thorough...
EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimer's Disease Patient
16th October 2009 WELLESLEY HILLS, Massachusetts, October 16 /PRNewswire/ -- The FDA has approved a Physician-Sponsored IND and continuation of the
fourth 6-month open label extension of PRX-03140, a novel 5HT4...
Oncolytics Biotech(R) Inc. Reaches Special Protocol Assessment Agreement With the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers
2nd October 2009 CALGARY, Canada, October 2 /PRNewswire/ -- Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today
announced that it has reached an agreement with the U.S. Food and Drug
Administration...
New Multicenter Study Finds That Cardiac Function Measured During Stress Testing With Cheetah Medical's BIOREACTANCE(R) Noninvasive Technology Offers New Insights Into Heart Failure
2nd October 2009 TEL-AVIV, Israel and PORTLAND, Oregon, October 2 /PRNewswire/ -- Results from a multicenter study of Cheetah Medical's Exercise Cardiac
Output (ECO(R)) stress test protocol for chronic heart failure...
Merck Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States
30th September 2009 GENEVA, September 30 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany,
announced today the submission of a New Drug Application (NDA) to the US Food
and Drug Administration...
Simbionix USA Corporation's Innovative Development Division Releases Two New Breakthrough Technologies
21st September 2009 CLEVELAND, Ohio, September 21 /PRNewswire/ -- Simbionix USA Corporation, the world's leading developer of medical
simulation systems, just released two new products: a new Laparoscopic
Essential...
/C O R R E C T I O N -- Merck Serono S A/
16th September 2009 GENEVA, September 16 /PRNewswire/ -- In the news release, "Merck Serono Growth Hormone Injection Device
easypod(R) Approved in Japan" issued on 16 Sep 2009 07:00 GMT, by Merck
Serono S A SWX:SEO...
Merck Serono Growth Hormone Injection Device easypod(R) Approved in Japan
16th September 2009 GENEVA, September 16 /PRNewswire/ -- Merck Serono, a division of Merck KGaA Darmstadt, Germany,
today announced that the Japanese health authorities, the Pharmaceutical and
Medical Devices Agency...
Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
3rd September 2009 PHILADELPHIA, September 3 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that it has received approval from
the US Food and Drug...
Pitavastatin is Non-Inferior to Atorvastatin and Simvastatin and Demonstrates Sustained Efficacy and Tolerability Over 52 Weeks
1st September 2009 BARCELONA, Spain, September 1 /PRNewswire/ -- New phase III data presented at the European Society of Cardiology
congress (ESC) demonstrated that pitavastatin is non-inferior to atorvastatin
and...
Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
1st September 2009 CAMBRIDGE, Massachusetts, September 1 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today reported that it has completed its
submission of a New...
Bavarian Nordic A/S - Half Year Interim Report 2009
28th August 2009 KVISTGAARD, Denmark, August 28 /PRNewswire/ -- Today Bavarian Nordic published the company's half-year interim report
2009. The full financial statements are available on the company's...
Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device
27th August 2009 SIOUX FALLS, South Dakota, August 27 /PRNewswire/ -- Sanford Health (www.sanfordhealth.org), a comprehensive health care
provider in the Upper Midwest, announced today a spinal implant developed...
Bavarian Nordic in Negotiations With the US Authorities for the Further Development of IMVAMUNE(R)
24th August 2009 KVISTGAARD, Denmark, August 24 /PRNewswire/ -- Bavarian Nordic A/S (OMX: BAVA) announced today that the US authorities
have initiated negotiations for a new contract to develop a freeze-dried
version...
Smith & Nephew Takes Single Injection PMA to Next Stage
19th August 2009 RALEIGH and DURHAM, North Carolina, August 19 /PRNewswire/ -- Smith & Nephew (NYSE: SNN; LSE: SN) Biologics & Spine is proceeding to
the next stage in the approval process for the U.S. launch of...
The European Commission Approves Samsca(TM) (tolvaptan), Europe's First and Only Oral Vasopressin Antagonist for Hyponatraemia Secondary to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
3rd August 2009 TOKYO, Japan and UXBRIDGE, England, August 3 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Europe Ltd.
(OPEL) announced today that the European Commission has approved...
Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
3rd August 2009 LEXINGTON, Massachusetts, August 3 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today reported positive results from the first of
three Phase...
© Copyright 1995-2009 Pharmalicensing, a division of UTEK Europe Ltd 
All rights reserved. Terms and Conditions | Contact us
