Post Marketing Research

Novartis new data reinforces superiority of Cosentyx® versus Stelara®* in achieving skin clearance for psoriasis patients

January 16, 2018

Basel, January 16, 2018 – Novartis announced today results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx® (secukinumab) compared to Stelara®* (ustekinumab) in delivering clear and almost clear skin in adults with moderate-to-severe plaque psoriasis at 12 weeks. The study results show 66.5% and 72.3% of patients treated with Cosentyx (p < 0.0001) […]

Novartis advances head-to-head superiority trials of Cosentyx® versus Humira®* and proposed biosimilar adalimumab

January 9, 2018

Basel, January 9, 2018 – Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondylitis (AS). SURPASS is the first head-to-head clinical trial in AS investigating superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab**. SURPASS is currently recruiting patients, with […]

Boehringer Ingelheim initiates real-world study of treatment sequencing in EGFR mutation-positive lung cancer

December 13, 2017

Ridgefield, Conn., December 12, 2017 – Boehringer Ingelheim has initiated GioTag, a real-world study to assess the impact of sequential therapy in patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). Data from approximately 190 patients who received tyrosine kinase inhibitors (TKI) – afatinib in first-line, followed by second-line osimertinib as part of standard […]

Sustained Benefit in Patients with Relapsed/Refractory Mantle Cell Lymphoma Demonstrated by 3½-Year Follow-Up Data of IMBRUVICA® (ibrutinib)

December 11, 2017

ATLANTA, GA and RARITAN, NJ, December 9, 2017 – Today, Janssen Research & Development, LLC (Janssen) announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with IMBRUVICA® (ibrutinib). The extended follow-up data demonstrated that patients treated with IMBRUVICA earlier (after first relapse) experienced the best clinical outcomes, in terms […]

Sanofi’s Toujeo® met main objective in head-to-head study versus insulin degludec

December 4, 2017

PARIS, FRANCE – December 4, 2017 – Sanofi’s Toujeo® met the primary study objective in the first large head-to-head clinical trial1, called BRIGHT study, comparing Toujeo with insulin degludec. Sanofi plans to provide full results in 2018.   The primary objective was to determine if the effect of Toujeo on blood sugar levels (HbA1c) was […]

WIRB-Copernicus Group Acquires Vigilare International

November 28, 2017

WCG expands portfolio to include top pharmacovigilance, drug safety solution provider WIRB Copernicus Group® (WCG™), the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, today announced its acquisition of Vigilare International, the top provider of integrated, end-to-end pharmacovigilance and drug safety solutions for the biopharmaceutical and biotech industry. […]

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 […]

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