| 2009-07-06: |
European Commission Approves Statement on Lipid Improvement for VIRAMUNE( R ) Label
Ingelheim, Germany ( PRN/ots ) - - For Medical Media Outside the US only Boehringer Ingelheim announced today that the European Commission has approved an update of the Summary of Product Characteristics ( SmPC ) for VIRAMUNE( R ) ( nevirapine ) in the treatment of patients with HIV. The decision (...) |
| 2009-07-02: |
FDA Approves Multaq( R ) for Patients With Atrial Fibrillation or Atrial Flutter
Paris ( PRN/ots ) - - Multaq( R ) Approved to Reduce the Risk of Cardiovascular Hospitalization in Patients With Atrial Fibrillation or Atrial Flutter - U.S Commercial Launch Planned for the Summer of 2009 Sanofi - aventis ( EURONEXT: SAN and NYSE: SNY ) announced today that the U.S. Food (...) |
| 2009-06-30: |
New Data Supports Significant Economic and Clinical Value of MENOPUR( R ) in IVF
Amsterdam, The Netherlands ( PRN/ots ) - - "Study Could Have Major Impact on the Decision - Making Process With Respect to Infertility Treatment" New data from an economic analysis presented today at this year's European Society of Human Reproduction and Embryology ( ESHRE ) congress showed that, (...) |
| 2009-06-26: |
European Regulator Gives Positive Opinion for the use of Avastin in Combination With docetaxel for the First - Line Treatment of Advanced Breast Cancer
Basel ( PRN/ots ) - - For non - US, non - UK and non - Austrian Media Patients with advanced ( metastatic ) breast cancer will be able to benefit from treatment with Avastin ( bevacizumab ) as a result of a new broader label recommendation in Europe, Roche announced (...) |
| 2009-06-26: |
Genomic Health Reports Favorable Commentary on Value of Multigene Assays From the St. Gallen Expert Consensus Meeting on the Primary Treatment of Early Breast Cancer
Geneva, and Redwood City, California ( PRN/ots ) - - Guidelines Specify that Validated Molecular Assays Should be Considered as an Adjunct to Standard Measures in Helping Determine Chemotherapy Benefit - Genomic Health, Inc. ( Nasdaq: GHDX ) today reported that the St. Gallen International Consensus Panel (...) |
| 2009-06-26: |
Boehringer Ingelheim Receives Positive Recommendation From European Scientific Committee for a New Once Daily Mirapexin( R ) ( Pramipexole ) Formulation for the Treatment Of Parkinson's Disease
Ingelheim, Germany ( PRN/ots ) - - For non - U.S. Healthcare Media Boehringer Ingelheim announced today that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMEA ) has issued a positive opinion recommending the approval of a once daily formulation (...) |
| 2009-06-25: |
ONGLYZA( TM ) ( saxagliptin ) Receives Positive Opinion in Europe for the Treatment of Type 2 Diabetes
Paris and London ( PRN/ots ) - Bristol - Myers Squibb Company ( NYSE: BMY ) and AstraZeneca ( LSE: AZN ) today announced that their marketing authorisation application for ONGLYZA( TM ) ( saxagliptin ) received a positive opinion from the Committee for Medicinal Products for Human Use ( CHMP ) for the treatment of type (...) |
| 2009-06-23: |
Abbott Receives CE Mark for Company's Next - Generation XIENCE PRIME( TM ) Drug Eluting Stent, Advancing Leadership Position
Abbott Park, Illinois ( PRN/ots ) - - Broad Size Matrix of XIENCE PRIME to be Launched in Europe in the Third Quarter Abbott announced today that it has received CE Mark ( Conformite Europeenne ) for its next - generation XIENCE PRIME( TM ) Everolimus Eluting Coronary Stent System (...) |
| 2009-06-23: |
Agendia's Breast Cancer Recurrence Test MammaPrint Included in International St. Gallen Expert Consensus Recommendations
Huntington Beach, California and Amsterdam ( PRN/ots ) - - International Expert Panel Recommends Use of Multigene Profiling Assays and Finds Intermediate Scores Lack Clinical Utility Agendia, a world leader in molecular cancer diagnostics, today announced the inclusion of its breast cancer recurrence test MammaPrint (...) |
| 2009-06-23: |
New Educational Initiative Urges People With Rheumatoid Arthritis ( RA ) to Dedicate One Day so That They May Make a Lasting Difference to How They Live With Their Condition
Maidenhead, England ( PRN/ots ) - - My Day for RA Launches Across Europe Today: A Novel 'Goal - Centred' Patient Programme Recognising that rheumatoid arthritis ( RA ) can cause deformity, disability and loss of independence without effective management - My Day for RA, a new educational programme, (...) |
| 2009-06-22: |
NeurogesX and Astellas Enter Commercialization Agreement for Qutenza( TM )
San Mateo, California and Staines, England ( PRN/ots ) - - Conference Call Today at 9:00am ET - Covers Europe, Middle East and Africa - Includes Licensing Option and Development Funding for NGX - 1998 NeurogesX, Inc. ( NASDAQ: NGSX ) and Astellas Pharma Europe Ltd., ( Astellas ), (...) |
| 2009-06-12: |
Wyeth Presents New Analyses of Data From Three Studies of ENBREL( R ) at the European League Against Rheumatism ( EULAR ) Annual Meeting
Maidenhead, England ( PRN/ots ) - - Two - year Data From COMET Study in Early Active Moderate - to - Severe Rheumatoid Arthritis Indicated Sustained Halt of Progressive Joint Damage - New Analyses From ASCEND Study in Ankylosing Spondylitis Indicated Improvement in Patients With and Without Peripheral Joint Involvement - (...) |
| 2009-06-11: |
New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13 - valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease
Collegeville, Pennsylvania ( PRN/ots ) - New data from Phase 3 European clinical trials reinforce that Wyeth's ( NYSE: WYE ) investigational pneumococcal vaccine, Prevenar 13* ( Pneumococcal Polysaccharide Conjugate Vaccine, 13 - valent [Adsorbed] ), has the potential to provide coverage against the 13 most prevalent serotypes (...) |
| 2009-06-08: |
Final Call for Entries to the 'Excellence in Epilepsy' Journalism Award
Brussels ( PRN/ots ) - The 'Excellence in Epilepsy' Journalism Award - an initiative of the International Bureau for Epilepsy ( IBE ) and UCB - invites journalists from around the world to submit stimulating, informed and compelling news and feature stories on epilepsy. The award seeks to increase awareness (...) |
| 2009-06-06: |
New Data From Boehringer Ingelheim's Ongoing Linagliptin Trial Programme Show Promising Safety and Efficacy Results
Ingelheim, Germany ( PRN/ots ) - - Results From Linagliptin Study in Type 2 Diabetes Patients Who Were Inadequately Controlled on Metformin Therapy Alone, Presented at Major Diabetes Meeting Study results presented for the first time in the scientific sessions of this year's American Diabetes (...) |
| 2009-06-04: |
Enbrel( R ) Receives Positive European Recommendations for a New Plaque Psoriasis Treatment Regimen and New Pre - Filled Pen Delivery Device
Maidenhead, England ( PRN/ots ) - - CHMP Recommends Approval of a Continuous Dosing Regimen Option for Enbrel In Plaque Psoriasis, and a New Pre - Filled Pen Delivery Device Today, Wyeth received positive recommendations from the European Committee for Medicinal Products for Human Use ( CHMP ) (...) |
| 2009-06-03: |
One - Year Phase III Study Confirms Ilaris( R ) Offers Long - Term Remission in Patients With CAPS, a Severe Lifelong Auto - Inflammatory Disease
Basel, Switzerland ( PRN/ots ) - - Not for US Media - New Ilaris Data in The New England Journal of Medicine Show Rapid Sustained Efficacy in Patients With Cryopyrin - Associated Periodic Syndrome ( CAPS )( 1 ) - CAPS is a Debilitating Genetic Disorder With Potentially Fatal Complications and Limited (...) |
| 2009-06-03: |
Investigational Cancer Drug BSI - 201 Showed Clinical Benefit in 62 Prozent of Patients with Triple - Negative Metastatic Breast Cancer and Significantly Prolonged Survival
Paris and Brisbane, California ( PRN/ots ) - - Data Highlighted in Plenary Session of 2009 American Society of Clinical Oncology Annual Meeting Sanofi - aventis ( EURONEXT: SAN and NYSE: SNY ) and its fully owned subsidiary, BiPar Sciences, today announced results from a randomized Phase 2 (...) |
| 2009-06-02: |
IMPACT Study Shows Longer Valcyte Treatment Provides Better Protection Against Cytomegalovirus ( CMV ) Disease CMV is the Most Serious Viral Infection Affecting Transplant Patients
Basel, Switzerland ( PRN/ots ) - - For Non - US Media Only New Phase III study results presented for the first time today at the ninth annual American Transplant Congress 2009 ( ATC ) demonstrate that doubling the duration of preventive therapy ( 'prophylaxis' ) with Valcyte ( oral valganciclovir ), (...) |
| 2009-06-01: |
Encouraging First Data on New Targeted Treatment for Patients With Melanoma - the Deadliest Form of Skin Cancer
Basel, Switzerland ( PRN/ots ) - - PLX4032 ( R7204 ) Phase I Results Offer Hope of First Highly Effective Drug in Melanoma Along With Companion Diagnostic - For Non - US Media Only Roche announced today results from a Phase I study with PLX4032 ( R7204 ) a (...) |
| 2009-05-30: |
Maintenance Treatment With Avastin and Tarceva in Combination Helps Lung Cancer Patients Live Longer Without Their Disease Worsening
Basel, Switzerland ( PRN/ots ) - - For ex - US Media Only - Phase III ATLAS Study Achieves a New Milestone in Treating Advanced Lung Cancer Roche announced today that the Phase III ATLAS study showed patients with advanced non - small cell lung cancer ( NSCLC ) (...) |
| 2009-05-29: |
Avastin Plus Commonly Used Chemotherapies Improves the Time Breast Cancer Patients Live Without Their Disease Getting Worse
Basel, Switzerland ( PRN/ots ) - - RIBBON - 1 Study Confirms Benefit of Avastin in Treating HER2 - Negative Breast Cancer - For Non - US, Non - UK and Non - Austrian Media Results from the phase III RIBBON - 1 study presented today at ASCO showed that patients (...) |
| 2009-05-29: |
New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER - 2 Positive Breast Cancer
Collegeville, Pennsylvania ( PRN/ots ) - Wyeth Pharmaceuticals, a division of Wyeth ( NYSE: WYE ), today announced preliminary data from two ongoing studies, one evaluating neratinib ( HKI - 272 ) in combination with trastuzumab ( Herceptin( R ), Roche ) in HER - 2 positive ( ErbB - 2 positive ) breast cancer, and a separate (...) |
| 2009-05-28: |
Agendia Supports Genentech's Citizen's Petition Urging FDA to Hold In - Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards
Huntington Beach, California, and Amsterdam ( PRN/ots ) - Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech's Citizen's Petition. Filed on December 5, 2008, Docket No. FDA - 2008 - P - 0638 - 0001/CP petitions that all in vitro diagnostic (...) |
| 2009-05-28: |
MDS Nordion Opens New Radiopharmaceutical Production Facility in Belgium
Ottawa, Canada and Fleurus, Belgium ( PRN/ots ) - - Site to Provide Fluorodeoxyglucose ( F - 18 FDG ) for use in Earlier Detection of Disease and Therapy Management MDS Nordion, a leading global provider of medical isotopes and radiopharmaceuticals used in molecular medicine, today announced (...) |
| 2009-05-27: |
New NICE Guideline for Type 2 Diabetes Recognises Benefits From Newer Agents for Blood Glucose Control
London ( PRN/ots ) - - For Healthcare and Pharmaceutical Correspondents Only - NICE Recommends Considering DPP - 4 Inhibitors as a Second Line Treatment Option in Appropriate Patients Merck Sharp & Dohme Limited ( MSD ) welcomes the publication of the guideline for type 2 diabetes newer (...) |
| 2009-05-27: |
Boehringer Ingelheim and the World Stroke Organization Announce Partnership in the World Stroke Academy
Ingelheim, Germany ( PRN/ots ) - - For Healthcare Media Outside the U.S.A., Canada, and Japan Boehringer Ingelheim announced today that it will become the founding sponsor of the World Stroke Academy, a novel training initiative for stroke professionals being developed by the World Stroke (...) |
| 2009-05-26: |
Agendia Opens CLIA - Registered U.S. Genomics Laboratory
Huntington Beach, California and Amsterdam ( PRN/ots ) - - Agendia Increases U.S. Footprint with Domestic Executive Team and Operations Agendia, a world leader in molecular cancer diagnostics, today announced the opening of its U.S. clinical genomics laboratory in Huntington Beach, CA. The laboratory is (...) |
| 2009-05-25: |
New Findings Provide Additional Insights into the Management of Anaemia and Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
Milan ( PRN/ots ) - Data presented from large - scale observational studies provide new insights into the day - to - day management of two major complications of CKD: anaemia and secondary hyperparathyroidism ( SHPT ).( 1 ), ( 2 ), ( 3 ), ( 4 ) - CKD anaemia: Aranesp( R ) ( darbepoetin alfa ) flexible dosing intervals help (...) |
| 2009-05-21: |
Innovative Treatment Approach Offers New Hope for Eczema Sufferers With Moderate to Severe Disease PROTOPIC( R )
Prague ( PRN/ots ) - - Ointment ( Tacrolimus Monohydrate ) in a New Twice - Weekly Regimen can Help Prevent Eczema Flares Today sees the European launch of the first topical calcineurin inhibitor to be approved for the maintenance treatment of eczema to prevent flares and prolong (...) |
| 2009-05-20: |
BIO International Convention 2009: Research Location Germany Presents Potential in Regenerative Medicine
Atlanta ( na Originaltextservice ) - Germany will present itself as one of the world's leading regenerative medicine research locations at this year's BIO International Convention. Under the "Breakthroughs in Regenerative Medicines in Germany" banner, German experts will provide invaluable insight into the latest research (...) |
| 2009-05-15: |
SHARE Program Launched to Address the Challenges of Achieving Blood Pressure Goal
Munich ( PRN/ots ) - - Investigating the Real Burden of Hypertension, Addressing the Challenges of Getting to Blood Pressure Goal and SHARE( ing ) the Knowledge ( http://www.SHARE - hypertension.com ) The SHARE steering committee announce the launch of Supporting Hypertension Awareness & Research Europe - wide ( SHARE ) program (...) |
| 2009-05-12: |
Occlutech obtains CE mark for the new generation PFO & ASD occluders
Jena ( na Originaltextservice ) - Occlutech, the leading European developer of septum occluders, today announced that it has obtained CE mark approval for its new generation ASD and PFO occluders, the Figulla Flex. The Figulla Flex ASD and PFO occluders encompass a new (...) |
| 2009-05-07: |
FDA Grants Priority Review Status to Prevnar 13 Marketing Application
Collegeville, Pennsylvania ( PRN/ots ) - - - Candidate vaccine designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease - - Wyeth Pharmaceuticals, a division of Wyeth ( NYSE: WYE ), announced today that the U.S. Food and Drug Administration ( FDA ) granted priority review to (...) |
| 2009-05-07: |
AMT Starts Preregistration Trial for Glybera( TM )
Amsterdam ( PRN/ots ) - Amsterdam Molecular Therapeutics ( Euronext: AMT ), a leader in the field of human gene therapy, announced today the treatment of the first patient in a preregistration clinical trial with Glybera( TM ). This gene therapy product targets lipoprotein lipase deficiency ( LPLD ), a seriously debilitating and (...) |
| 2009-04-30: |
Outcome of New Mirapexin( R )/Sifrol( R ) ( Pramipexole ) Study set to Change Treatment of Depressive Symptoms in Parkinson's Disease
Ingelheim, Germany ( PRN/ots ) - - New Study Shows That Mirapexin( R )/Sifrol( R ) ( Pramipexole ) Relieves Depressive Symptoms of Parkinson's Disease ( PD ), a Common Non - Motor Symptom Affecting PD Patients' Quality of Life - For Non - US Healthcare Media To view the Multimedia News Release, go (...) |
| 2009-04-29: |
New Study Results Support Once Daily, Prolonged Release Formulation of Mirapexin( R )/Sifrol( R ) ( Pramipexole ) for the Treatment of Parkinson's Disease
Ingelheim, Germany ( PRN/ots ) - - Data for the Once Daily Mirapexin( R )/Sifrol( R ) ( Pramipexole ) Formulation Under Development Show Efficacy, Safety and Tolerability Outcomes Comparable to the Current Immediate Release Formulation for the Treatment of Parkinson's Disease For non - US Healthcare Media First data showing (...) |
| 2009-04-27: |
Wyeth's CONBRIZA Approved in the European Union for Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture
Collegeville, Pennsylvania ( PRN/ots ) - Wyeth Pharmaceuticals, a division of Wyeth ( NYSE: WYE ), announced today that the European Commission has granted marketing authorization for CONBRIZA( TM ) ( bazedoxifene ), a selective estrogen receptor modulator ( SERM ), for the treatment of postmenopausal osteoporosis in women at increased risk of (...) |
| 2009-04-25: |
Ground - Breaking Combination of All - Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen
BASEL, Switzerland, BRISBANE, California and PRINCETON, New Jersey, April 25 ( PRN/ots ) - - - Combination of R7227, Protease Inhibitor, and R7128, Nucleoside Polymerase Inhibitor, Shows Significant Potency in Reducing Viral Load in Patients With Hepatitis C Roche ( SWX: RO, ROG; OTCQX: RHHBY ), InterMune, Inc. (...) |
| 2009-04-24: |
Roche Announces Collaboration to Investigate New Treatment Strategy With Tarceva in Lung Cancer
Basel, Switzerland ( PRN/ots ) - - New Phase III Study Will Evaluate if Tarceva is Superior to Traditional Chemotherapy in First Line Treatment of key Group of Patients Roche and the Spanish Lung Cancer Group ( SLCG ) today announced their collaboration on the first phase (...) |
| 2009-04-20: |
Newly Published Study Shows That Re - Treatment With Pegasys( R ) ( Peginterferon Alfa - 2a ) Provides Hepatitis C Patients With a Second Chance for a Cure
Basel, Switzerland ( PRN/ots ) - New data published today in a major peer - reviewed journal, Annals of Internal Medicine, show that re - treatment with Pegasys( R ) ( peginterferon alfa - 2a ) plus Copegus( R ) ( ribavirin ) provides previously - treated hepatitis C patients a second chance for a cure. The study (...) |
| 2009-04-17: |
New Partnerships Added to World Federation of Hemophilia Twinning Program
Collegeville, Pennsylvania ( PRN/ots ) - - Wyeth and Advocacy Community Mark Continued Commitment to Patient Care on World Hemophilia Day In honor of the twentieth Anniversary of World Hemophilia Day, Wyeth Pharmaceuticals, a division of Wyeth ( NYSE: WYE ), together with the World Federation of (...) |
| 2009-03-31: |
Avastin Label Updated Reflecting Confidence in Safety Profile
Basel, Switzerland ( PRN/ots ) - - Contraindication for Patients With Untreated Brain Metastases Removed - For non - US, UK and Austrian Media Only The European Medicines Agency ( EMEA ) has removed a restriction in the product label which prevented the use of Avastin( R ) ( bevacizumab ) in some (...) |
| 2009-03-31: |
Wyeth Submits Marketing Application to FDA for its 13 - Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers
Collegeville, Pennsylvania ( PRN/ots ) - - Candidate vaccine designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease - Wyeth Pharmaceuticals, a division of Wyeth ( NYSE: WYE ), announced today that it has submitted a Biologic License Application ( BLA ) to the U.S. (...) |
| 2009-03-31: |
Leading HIV Experts Convene to Tackle the Challenge of Late Presentation in Europe
London ( PRN/ots ) - - Between 15 to 38 percent of HIV - infected persons in Europe do not present for screening and treatment until late in infection.( 1 ) Late presentation has been show to result in increased morbidity( 1 ) and decreasing quality of life.( 2,3 ) Almost three (...) |
| 2009-03-31: |
World Heart Federation, Daiichi Sankyo and Lilly Partner to Improve Cardiovascular Health
Orlando, Florida ( PRN/ots ) - The World Heart Federation, Daiichi Sankyo Company, Limited ( TSE: 4568 ) and Eli Lilly and Company ( NYSE: LLY ) announced today that they have partnered to improve cardiovascular health internationally. The organizations made the announcement at the 58th Annual (...) |
| 2009-03-30: |
Patients Receiving Haemodialysis for Treatment of End Stage Renal Disease did not Benefit From Statin Therapy in the AURORA Study
Orlando, Florida ( PRN/ots ) - New data from the AURORA trial, a study in patients with end stage renal disease ( ESRD ) undergoing chronic haemodialysis, showed that there was no difference between rosuvastatin 10mg and placebo in reducing the combined endpoint of cardiovascular ( CV ) death, nonfatal (...) |
| 2009-03-29: |
CRESTOR( R ) Reduced CV Risk in Patients Achieving Low LDL - C and hsCRP Targets in New Jupiter Analysis
Orlando, Florida ( PRN/ots ) - Results from a new sub - analysis of the JUPITER study show that patients who attained a dual treatment target of LDL - C <70mg/dL and high - sensitivity C - reactive protein ( hsCRP ) <2mg/L with CRESTOR ( rosuvastatin ) 20mg achieved a greater (...) |
| 2009-03-29: |
CRESTOR( R ) is the First Statin to Reduce Risk of Blood Clots in Veins in a Large Prospective Randomised Study
Orlando, Florida ( PRN/ots ) - - A New Analysis From the JUPITER Trial A new analysis from the JUPITER study shows that CRESTOR ( rosuvastatin ) 20mg significantly cut the risk of venous thromboembolism ( VTE ) by 43 Prozent ( p =0.007 ) compared to placebo among men and women (...) |
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