Post Marketing Research

New Real-World Analysis Shows INVOKANA® (canagliflozin) and Other SGLT2 Inhibitors Reduced the Risk of Death and Cardiovascular Events Compared to Other Diabetes Medicines

November 20, 2017

TITUSVILLE, N.J., Nov. 17, 2017 /PRNewswire/ — A new real-world analysis of adults with type 2 diabetes and established cardiovascular disease (CVD) shows adult patients who initiated therapy with INVOKANA® (canagliflozin) or another sodium glucose cotransporter-2 inhibitor (SGLT2i) had a 43 percent reduced risk for all-cause mortality (ACM) and hospitalization for heart failure (HHF) after […]

Bioclinica Acquires MDDX Research & Informatics Combining Advanced Image Management Cloud Technology with Its Scientific and Medical Imaging Leadership

November 7, 2017

Best-in-class solution ensures sponsors and CROs have global access to efficient, accurate, and scalable medical imaging to drive better data and outcomes DOYLESTOWN, Pa., Nov. 6, 2017 – Bioclinica®, the world-leading provider of scientific-enabled Medical Imaging, eHealth, and patient-centric solutions supporting clinical research, today announces it has acquired Silicon Valley-based MDDX Research & Informatics, adding […]

Novartis seeks leadership with Cosentyx® showing no radiographic progression in ankylosing spondylitis at 4 years

November 6, 2017

Basel, November 6, 2017 – Novartis announced today new long-term Cosentyx® (secukinumab) data for patients with ankylosing spondylitis (AS)[1]. This study is unique as these data show, for the first time with any biologic, that almost 80 percent of AS patients treated with Cosentyx have no radiographic progression (mSASSS <2) of the spine at 4 […]

Adapt Pharma® Presents Human Factors Study Data on Usability of NARCAN® (naloxone HCl) Nasal Spray at the 41st Association for Medical Education & Research in Substance Abuse Annual National Conference

November 3, 2017

DUBLIN, Nov. 3, 2017 /PRNewswire/ — Adapt Pharma, Inc. (www.adaptpharma.com) presented findings from two human factors studies conducted, as a part of its Food and Drug Administration (FDA) product approval, to evaluate the usability of NARCAN® Nasal Spray by adolescents and individuals including those with low literacy. The poster titled, Usability of Naloxone Nasal Spray […]

Novartis PARADIGMS data show children and adolescents with MS had an 82% lower relapse rate with Gilenya® vs. interferon beta-1a

October 30, 2017

Basel, October 28, 2017 – Novartis today announced full results from the positive Phase III PARADIGMS study, investigating the safety and efficacy of Gilenya® (fingolimod) vs. interferon beta-1a, in children and adolescents (ages 10 to 17) with multiple sclerosis (MS). Treatment with oral Gilenya resulted in an 82% reduction in the rate of relapses (annualized […]

Novartis to present first of its kind evidence for Cosentyx® on potential to maintain mobility in patients with AS and PsA

October 30, 2017

Basel, October 30, 2017 – New evidence on the efficacy of the innovative biologic Cosentyx® (secukinumab) demonstrating its potential to reduce structural disease progression in patients with specific rheumatological conditions will be presented at the 2017 ACR/ARHP Annual Meeting in San Diego, United States. The Cosentyx late breaking presentations will include new 4-year data from […]

Novartis drug Promacta® shows long-term disease control for chronic/persistent immune thrombocytopenia (ITP)

October 18, 2017

EAST HANOVER, N.J., Oct. 18, 2017 /PRNewswire/ — Novartis today announced long-term study results supporting the positive safety and efficacy of Promacta (eltrombopag) in adults with chronic/persistent (enrolling patients that were 6 or more months from diagnosis) immune (idiopathic) thrombocytopenia (ITP) were published online in Blood. The EXTEND study found that a majority of patients […]

Novartis drug Revolade® shows long-term disease control for chronic/persistent immune thrombocytopenia (ITP)

October 18, 2017

Basel, October 18, 2017 – Novartis today announced long-term study results supporting the positive safety and efficacy of Revolade (eltrombopag) in adults with chronic/persistent (enrolling patients that were 6 or more months from diagnosis) immune (idiopathic) thrombocytopenia (ITP) were published online in Blood. The EXTEND study found that a majority of patients maintained a substantial […]

New Post-Hoc Analyses Report Early Symptomatic Improvement in Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Patients Taking Entyvio® (vedolizumab), Particularly in Biologic-Naïve Patients

October 17, 2017

OSAKA, Japan, Oct. 16, 2017 /PRNewswire/ — Takeda Pharmaceutical Company Limited (TSE: 4502), (“Takeda”) today announced the presentation of data suggesting early symptomatic improvement in specific symptoms with Entyvio® (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), particularly in biologic-naïve patients for whom other therapies have not worked […]

New Post-Hoc Analyses Report Early Symptomatic Improvement in Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Patients Taking Entyvio® (vedolizumab), Particularly in Biologic-Naïve Patients

October 17, 2017

OSAKA, Japan, Oct. 16, 2017 /PRNewswire/ — Takeda Pharmaceutical Company Limited (TSE: 4502), (“Takeda”) today announced the presentation of data suggesting early symptomatic improvement in specific symptoms with Entyvio® (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), particularly in biologic-naïve patients for whom other therapies have not worked […]

Sword and Medexprim : combining clinical and imaging data in big-data research projects

October 12, 2017

Sword Group and Medexprim are partnering in view to offer cancer centers and large hospitals a unified solution to facilitate translational research, combining clinical and imaging data. SWORD GROUP has developed the innovative solution ConSoRe, in partnership with Unicancer, which federates 20 French leading not-for profit private cancer hospitals (« centres de lutte contre le cancer», http://www.unicancer.fr/unicancer) in France.  ConSoRe is an evolved […]

Jardiance® (empagliflozin) tablets reduced risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease independent of background blood sugar control

September 12, 2017

RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 12, 2017 /PRNewswire/ — New analyses of the landmark EMPA-REG OUTCOME® trial showed that Jardiance® (empagliflozin) tablets reduced the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, independent of blood sugar control at the start of the study. A reduction in cardiovascular death was […]

Positive results from pioneering Salford Lung Study in asthma published in The Lancet, and presented at European Respiratory Congress

September 11, 2017

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive results from the Salford Lung Study (SLS) in asthma have been simultaneously published in The Lancet journal and presented at the European Respiratory Society (ERS) International Congress in Milan. The innovative study, which reported headline results in May 2017, showed that initiation of […]

New Sub-analysis Data Highlights the Benefit of LIXIANA®▼ (edoxaban) Over Warfarin in NVAF Patients According to More Comprehensive Stroke Risk Scoring

August 30, 2017

MUNICH, August 29, 2017 /PRNewswire/ —     Sub-analysis highlights the protective effect of edoxaban against stroke or systemic embolic events (SEEs) and its superior safety in terms of major bleeding risk compared to warfarin, in non-valvular atrial fibrillation (NVAF) patients at varying levels of stroke risk.[1] The data is being presented at ESC Congress […]

New Repatha® (evolocumab) Analysis Demonstrates Cardiovascular Outcomes Efficacy And Safety Of Achieving Very Low LDL-C Levels

August 28, 2017

THOUSAND OAKS, Calif., Aug. 28, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced a new analysis from the Repatha® (evolocumab) cardiovascular outcomes study (FOURIER) that showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease. There was no evidence of a […]

Victoza® Reduces the Risk of Major Cardiovascular Events in People with Type 2 Diabetes With or Without Prior Events

August 28, 2017

BARCELONA, Spain, August 28, 2017 /PRNewswire/ —   Oral Presentation 3909   A new analysis of the landmark LEADER trial shows that Victoza® (liraglutide) reduced the risk of major cardiovascular (CV) events in people with type 2 diabetes at high CV risk, irrespective of their history of having a heart attack and/or stroke or not […]

Bristol-Myers Squibb and Pfizer Present Observational Real-World Data Analysis on the Effectiveness and Safety of Eliquis® (apixaban) Compared to Warfarin in Select High-Risk Patients with Non-Valvular Atrial Fibrillation

August 28, 2017

PRINCETON, N.J. & NEW YORK–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced results from an analysis of real-world data pooled from four large U.S. insurance claims databases. Among non-valvular atrial fibrillation (NVAF) patients, Eliquis ® (apixaban) was associated with a lower risk of stroke/SE and lower rates of major bleeding compared to […]

Anika Announces Publication of Data Demonstrating the Efficacy and Safety of HYALOFAST® in Combination with Stem Cells for the Treatment of Cartilage Lesions on the Knee

August 8, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the publication of data demonstrating that HYALOFAST®, a biodegradable HA-based scaffold, used in combination with autologous adult mesenchymal stem cells (MSCs), regardless of a patients’ age, is a viable […]

Mallinckrodt Enrolls First Patient In Phase 4 Registry Of INOMAX® (Nitric Oxide) Gas For Inhalation For Pulmonary Hypertension In Neonates

August 2, 2017

STAINES-UPON-THAMES, United Kingdom, Aug. 1, 2017 /PRNewswire/ — Mallinckrodt Pharmaceuticals (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed inclusion of the first patient in the company’s Phase 4 registry assessing the use of INOMAX® (nitric oxide) gas for inhalation for premature (less than 34 weeks gestational age) neonates versus term and near-term neonates […]

Alimera Sciences Announces Real-World Audit Data Supporting the Positive Benefits of ILUVIEN® Treatment

July 27, 2017

ATLANTA, July 25, 2017 (GLOBE NEWSWIRE) — Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that data from an ongoing audit of real-world U.K. clinical practice, published online July 18, 2017 in Eye, show a significant number of patients with chronic diabetic macular edema (DME) […]

Pacira Announces Publication of Phase 4 Study of EXPAREL in Patients Undergoing Total Knee Replacement in The Journal of Arthroplasty

July 26, 2017

PARSIPPANY, N.J., July 26, 2017 (GLOBE NEWSWIRE) — Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced the publication of its Phase 4 PILLAR study of EXPAREL® (bupivacaine liposome injectable suspension) in total knee arthroplasty (TKA). The results, which demonstrate a statistically significant reduction in opioid requirements and pain scores for EXPAREL admixed with bupivacaine HCl versus bupivacaine […]

Switching to a dolutegravir regimen from a boosted protease inhibitor regimen maintained viral suppression and improved lipid fractions in patients with HIV and high cardiovascular risk

July 25, 2017

London, UK. 25 July 2017 – ViiV Healthcare and NEAT-ID announced results from the NEAT 022 study of more than 400 patients with HIV and high cardiovascular risk. The study was conducted by the NEAT-ID group with support from ViiV Healthcare and St Stephen’s AIDS Trust (SSAT), and showed that switching virologically suppressed patients at […]

Positive Results Enable Alimera Sciences to Reduce Enrollment in ILUVIEN® Registry Safety Study in the U.K.

July 20, 2017

ATLANTA, July 19, 2017 (GLOBE NEWSWIRE) — Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization, research and development of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has given final approval to reduce the size of its ILUVIEN Registry Safety Study (IRISS).   A post-marketing […]

Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx® reinforcing sustained efficacy and safety profile in psoriasis

July 17, 2017

Basel, July 14, 2017 – Novartis, a global leader in Immunology & Dermatology, confirmed today positive 5 year efficacy and safety results for Cosentyx® from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis[1]. Data will be presented at a key medical congress in the second half of 2017. 5 year Phase […]

Teva and the Huntington Study Group Announce Publication of Data for AUSTEDO™ (deutetrabenazine) Tablets in Huntington Disease from ARC-HD Study in JAMA Neurology

July 12, 2017

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and the Huntington Study Group today announced results from the Phase III open-label, single-arm switch cohort of the ARC-HD (Alternatives for Reducing Chorea in HD) study were published in JAMA Neurology. Results from the study showed patients with chorea associated with Huntington disease (HD) were able to […]

Allergan Reports New Data Reinforcing the Effectiveness of Viberzi® (Eluxadoline) to Treat the Symptoms Associated with Irritable Bowel Syndrome with Diarrhea (IBS-D), Abdominal Pain and Diarrhea

July 11, 2017

DUBLIN, July 10, 2017 /PRNewswire/ — Allergan plc (NYSE:AGN) announced additional results of a prespecified prospective pooled subgroup analysis from the two Phase 3 studies (IBS-3001 and IBS-3002), which evaluated the efficacy and safety of Viberzi in nearly 2,500 IBS-D patients, of whom 36 percent reported use of loperamide in the 12 months prior to […]

ISTH 2017, Berlin: Octapharma presents exciting Nuwiq® data in previously untreated patients and demonstrates real-life value of personalised prophylaxis for Haemophilia A

July 10, 2017

LACHEN, Switzerland–(BUSINESS WIRE)–Octapharma is playing a prominent role this week at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Berlin, Germany. As a platinum sponsor of the congress, Octapharma’s active involvement includes two sponsored scientific symposia, one of which is dedicated to exploring recent data and real-world experiences with Nuwiq®, the most recent […]

ALK – Five-year GRAZAX(R) Asthma Prevention (GAP) Trial Reveals Benefits of Early Treatment Intervention in Children

July 7, 2017

The disease modifying property of GRAZAX® (SQ® grass SLIT-tablet) resulted in long-term effect on allergic rhinoconjunctivitis (ARC) and prevented asthma symptoms, even two years after end of treatment in children with grass pollen ARC and no existing signs or symptoms of asthma Younger children had a higher probability of developing asthma. The younger the children […]

FEEDBACK