Post Marketing Research

Integreview IRB Adds Renowned Professor Emeritus to Team

July 11, 2018

IntegReview IRB announces that Ernest D. Prentice, Ph.D., has joined the organization as a Senior Consultant to the IRB. In his new role, Dr. Prentice will work with IntegReview leadership to provide consultation to the IRB and educate researchers by speaking at upcoming research conferences. “We are thrilled to work with someone as experienced and […]

Novartis presents data to advance understanding of the role of IL-17A and reinforce Cosentyx® leadership in spondyloarthritis

June 13, 2018

Basel, June 13, 2018 – Novartis will attend the Annual European Congress of Rheumatology (EULAR 2018) with 26 accepted abstracts reinforcing the roles of Cosentyx® (secukinumab) and IL-17A, cornerstone cytokine in the development of ankylosing spondylitis (AS) and psoriatic arthritis (PsA)[1]. EULAR 2018 will be taking place June 13-16, in Amsterdam, Netherlands. “For patients living […]

GSK presents new results showing low rates of organ damage with long term use of Benlysta

June 13, 2018

GSK today announced results from two new analyses showing low rates of organ damage progression in patients with active systemic lupus erythematosus (SLE) treated with Benlysta (belimumab). These data will be presented at the 2018 Annual European College of Rheumatology (EULAR). Patients with SLE are at risk of irreversible damage across multiple organ systems because […]

Synergy Pharmaceuticals Highlights New Data at Digestive Disease Week (DDW) 2018 Linking Uroguanylin Deficiency to Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C)

June 6, 2018

NEW YORK–(BUSINESS WIRE)–Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, announced today new data presented at Digestive Disease Week (DDW) 2018 showing chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are associated with depressed levels of uroguanylin, a naturally occurring and endogenous […]

LYNPARZA® (olaparib) in Combination With Abiraterone Delayed Disease Progression in Metastatic Castration-Resistant Prostate Cancer

June 5, 2018

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with LYNPARZA® (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic castration-resistant prostate cancer (mCRPC). […]

New Novartis data presented at ASCO find nearly half of CML patients treated with Tasigna® remain in remission almost three years after stopping therapy

June 4, 2018

EAST HANOVER, N.J., June 2, 2018 /PRNewswire/ — New Novartis data from two long-term Treatment-free Remission (TFR) studies in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP) will be presented during the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Results from the open-label […]

New Real-World Study Finds Long-Term XARELTO® (rivaroxaban) Use Resulted in Fewer Strokes and Systemic Emboli Compared to Warfarin in Frail Patients with Non-Valvular Atrial Fibrillation

May 25, 2018

TITUSVILLE, N.J., May 24, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new real-world data that showed frail patients with non-valvular atrial fibrillation (NVAF) experienced significantly fewer strokes and systemic emboli when treated with XARELTO® (rivaroxaban) over a two-year period compared to those taking warfarin. Specifically, long-term XARELTO® use reduced […]

Efficacy and safety of Ofev® (nintedanib) reinforced in new presentations at ATS 2018

May 23, 2018

RIDGEFIELD, Conn., May 21, 2018 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced new presentations at the American Thoracic Society’s 2018 annual conference that reinforce the efficacy, safety and tolerability profile of Ofev® (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF).   “The data presented at the conference support the established efficacy of Ofev, while […]

Head-to-head pharmacokinetic study demonstrated greater factor IX activity with Rebinyn® versus rFIXFc in people with hemophilia B

May 23, 2018

PLAINSBORO, N.J., May 21, 2018 /PRNewswire/ — A new head-to-head pharmacokinetic study showed that adults with hemophilia B who received a single dose (50 IU/kg) of Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated] achieved high factor IX activity for longer than those treated with rFIXFc [Coagulation Factor IX (Recombinant), Fc Fusion Protein]. Factor IX activity observed […]

Shire Releases Data at THWFH Congress 2018 Evaluating Vonvendi® in Adults With Von Willebrand Disease During and After Surgery

May 22, 2018

– Study evaluated safety, efficacy of recombinant von Willebrand factor with or without recombinant FVIII – Findings suggest potential for more tailored treatmen – VONVENDI [von Willebrand factor (Recombinant)] is approved only in the U.S. Zug, Switzerland – May 22, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) the global biotech leader in rare diseases, […]

Neurocrine Biosciences Presents New Quality of Life Data from RE-KINECT, the Largest Real-World Screening Study of Possible Tardive Dyskinesia in Patients Treated with Antipsychotics

May 9, 2018

SAN DIEGO, May 8, 2018 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced new data from RE-KINECT, the largest real-world screening study to date of patients with clinician-confirmed possible tardive dyskinesia (TD), providing valuable insight into the impact of involuntary movements on the quality of life of patients taking antipsychotic medication. TD is a […]

Galderma Announces Results of ALAMO: A Real-World, Phase 4 Study Demonstrating Efficacy and Safety of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Plus Oral Doxycycline 200 mg in Treating Severe Inflammatory Acne

May 8, 2018

FT. WORTH, Texas, May 7, 2018 /PRNewswire/ — Galderma, a global leader focused on medical solutions for skin health, announces the publication of results from the Phase 4 ALAMO study, which evaluated the efficacy and safety of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% plus oral doxycycline 200 mg in patients with severe inflammatory […]

Mavenclad (Cladribine Tablets) Data in Multiple Sclerosis Journal Show an Even Greater Treatment Effect in Patients With Highly Active Multiple Sclerosis

May 2, 2018

DARMSTADT, Germany, May 2, 2018 /PRNewswire/ —   – Post-hoc analysis from the 2-year CLARITY study demonstrated that Mavenclad reduced the risk of 6-month EDSS progression by 47% vs placebo   – Patients with highly active multiple sclerosis had an even greater treatment effect, reducing the risk by 82% vs placebo     Merck, a […]

A Retrospective Literature Review Published in Pain Management on Prescribing Naloxone for Opioid Overdose Intervention Highlights Opportunities to Expand Community Access to Help Reduce Fatalities

April 25, 2018

DUBLIN, April 25, 2018 /PRNewswire/ — A retrospective literature review, published today in Pain Management, examined prescription naloxone as a harm-reduction strategy and outlined opportunities to expand naloxone use more widely into the community to help reduce opioid overdose fatalities. Researchers used PubMed to identify English-language publications from January 2000 to October 2017 that discussed […]

Relapsing MS Patients Who Switched to Aubagio® (teriflunomide) Reported Increased Treatment Satisfaction in Two Clinical Studies

April 23, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Patients with relapsing multiple sclerosis who switched to Sanofi Genzyme’s Aubagio® (teriflunomide) from interferon therapy experienced improvements in treatment satisfaction, according to investigational data from two clinical studies. These results will be presented this week during the 70th annual meeting of the American Academy of Neurology (AAN) in Los Angeles, CA.   The […]

Theravance Biopharma Highlights Landmark IMPACT Study Published in NEJM Showing Significant Benefits of Trelegy Ellipta for COPD Patients

April 20, 2018

DUBLIN, April 19, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study of Trelegy Ellipta in patients with chronic obstructive pulmonary disease (COPD). The IMPACT study is one of the largest trials ever conducted in COPD patients […]

Wize Pharma Enrolls First Patient in Phase IV Study of LO2A for Symptomatic Treatment of Dry Eye Syndrome in Patients With Sjögren’s Syndrome

March 29, 2018

HOD HASHARON, Israel, March 28, 2018 /PRNewswire/ — Wize Pharma, Inc. (OTCQB: WIZP) (OTCQB: WIZPD) a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, today announced it has enrolled the first patient in its Phase IV clinical trial in Israel for LO2A in the symptomatic treatment of dry eye syndrome (DES) in patients […]

Pfizer Reports Top-Line Results from a Study of CHANTIX®/CHAMPIX® (varenicline) in Adolescent Smokers

March 23, 2018

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today results from a Phase 4 study evaluating the efficacy and safety of CHANTIX®/CHAMPIX® (varenicline) for smoking cessation in nicotine dependent adolescents 12-19 years of age. The study did not meet its primary endpoint of the four-week continuous abstinence rate at weeks 9 through 12 for CHANTIX/CHAMPIX compared to […]

New Data Presented at MDA Clinical Conference Show Benefit in Motor Function for Infants, Teens and Young Adults Treated With SPINRAZA® (nusinersen)

March 13, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen (Nasdaq: BIIB) today announced new interim Phase 2 results from NURTURE, the ongoing open-label, single-arm study evaluating the efficacy and safety of SPINRAZA® (nusinersen) among pre-symptomatic infants with spinal muscular atrophy (SMA). In NURTURE, all infants treated with SPINRAZA were alive, did not require permanent ventilation and showed improvement in motor function […]

Sanofi: Praluent® (alirocumab) significantly reduced risk of cardiovascular events in high-risk patients, and was associated with lower death rate

March 12, 2018

Paris and Tarrytown, N.Y. – March 10, 2018 – Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent® (alirocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack. […]

INVOKANA® (canagliflozin) Significantly Reduces the Risk of Heart Failure-Related Outcomes in Type 2 Diabetes Patients at Risk for or With a History of Cardiovascular Disease

March 12, 2018

ORLANDO, Fla., March 11, 2018 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results of a new analysis showing that INVOKANA® (canagliflozin) significantly reduced the risk of cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with type 2 diabetes (T2D) at high CV risk. This exploratory analysis from […]

Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants

March 12, 2018

PRINCETON, N.J. & NEW YORK, N.Y.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) will present findings today from a real-world data (RWD) analysis titled, Comparison of Effectiveness, Safety, and the Net Clinical Outcome between Different Direct Oral Anticoagulants in 162,707 Non-Valvular Atrial Fibrillation Patients Treated in US Clinical Practice. This is the […]

New Data Presented at MDA Clinical Conference Show Benefit in Motor Function for Infants, Teens and Young Adults Treated With SPINRAZA® (nusinersen)

March 12, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen (Nasdaq: BIIB) today announced new interim Phase 2 results from NURTURE, the ongoing open-label, single-arm study evaluating the efficacy and safety of SPINRAZA® (nusinersen) among pre-symptomatic infants with spinal muscular atrophy (SMA). In NURTURE, all infants treated with SPINRAZA were alive, did not require permanent ventilation and showed improvement in motor function […]

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