Sandoz presents new long-term and switching data for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in rheumatoid arthritis

June 15, 2018

Holzkirchen, June 15, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly® (infliximab)[4],[5] and biosimilar Erelzi® (etanercept).[6],[7] Research from the 54-week REFLECTIONS B537-02 study of Zessly and the 48-week EQUIRA study of Erelzi showed that […]

Novartis study of real-world data concludes Jakavi is associated with a reduction in risk of death and dangerous blood clots for patients with rare blood cancer

June 15, 2018

Basel, June 15, 2018 – Novartis announced today results from a new comparison study showing that Jakavi® (ruxolitinib)-treated patients with polycythemia vera (PV), who were resistant or intolerant to hydroxyurea (HU), had a significantly reduced risk of thrombosis (blood clots) and death compared to PV patients who received best available therapy[1]. The study findings are […]

Novartis International AG: Patient-reported outcomes tool revealed significant improvement in symptom frequency and quality of life domains with Entresto®

May 29, 2018

Basel, May 28, 2018 – Novartis announced today new real world evidence from the CHAMP-HF registry comparing Entresto® (sacubitril/valsartan) patients to patients not taking Entresto.[1] This pre-specified analysis of an interim data cut from the CHAMP-HF registry showed that chronic heart failure (HF) patients with reduced ejection fraction (HFrEF) taking Entresto reported early, statistically significant […]

A Study Analyzing Observational Data Shows Real-World Effectiveness of Prevnar® 13 in Adults Age 65+

May 23, 2018

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that results from a study analyzing real-world effectiveness data found that Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) reduced the risk of hospitalization from vaccine-type pneumococcal community-acquired pneumonia (CAP) by 73% (95% CI: 12.8−91.5%) in adults aged 65 and older.1 Importantly, Prevnar 13 (PCV13) worked […]

Real-World Evidence from McKesson Supports First-Ever FDA Approval for Metastatic Merkel Cell Carcinoma Drug

May 22, 2018

Study Wins the 2018 Clinical and Research Excellence (CARE) Award for Best in Health Economics and Outcomes THE WOODLANDS, Texas–(BUSINESS WIRE)–A powerful, real-world evidence study designed by McKesson Specialty Health for its biopharma partner played a key role in the Food and Drug Administration’s (FDA) approval for first-line indication for a rare disease. Recently “Merkel […]

ERT and Foundry3 Partner to Deliver Best-in-class Patient Support Programs

May 9, 2018

ERT and Foundry3 Partner to Deliver Best-in-class Patient Support Programs Insight into patient behaviors and scalable digital health services combine to improve clinical outcomes PHILADELPHIA – May 9, 2018 – ERT, a global data and technology company dedicated to improving health outcomes through innovative drug development and patient support solutions, and Foundry3, a creative, science […]

New Release of Cenduit’s IRT Platform and Quantum Interactive™ Updates Enable Efficient Technology Transfer and Increased Reports Customization for Clinical Trials

April 24, 2018

Durham, NC – Cenduit LLC continues to drive innovation and quality as a leader in the Interactive Response Technology (IRT) marketplace, with the latest release of the Cenduit IRT platform and Quantum Interactive ™. Cenduit CIRT combines faster study set-up times with the flexibility and benefits of customization. This enables sponsors to better meet the […]

CRF Health’s TrialMax eCOA Solution Selected for Landmark Pain Outcomes Study by Global Japanese Pharmaceutical Company

April 23, 2018

Plymouth Meeting, PA – April 23, 2018: CRF Health, the leading provider of patient-centered eSource for the life sciences industry, today announced that its TrialMax Touch® and TrialMax Slate® solutions have been selected by a Global Category Japanese Pharmaceutical company for a significant pain trial. The Phase III trial will involve 800 screened and 320 […]

Certara Acquires Analytica Laser, a Leader in Market Access, Health Economics and Outcomes Research (HEOR), and Real-world Evidence Solutions

April 12, 2018

Acquisition adds real-world effectiveness prediction and value assessment to Certara’s model-informed drug development and regulatory science decision-making portfolio Certara®, the global leader in model-informed drug development and regulatory science, today announced that it has acquired Analytica Laser, a global research consultancy that uses health economics and outcomes research (HEOR) and real-world data to provide the […]

ActiGraph Collaborates with Bayer in Mobile App Usability Pilot Study

April 11, 2018

Pensacola, FL (April 12, 2018) – ActiGraph, a leading provider of medical-grade wearable activity and sleep monitoring solutions, is collaborating with Bayer in an ongoing pilot study evaluating usability and patient perceptions of a digital tool suite consisting of Clinical Ink’s SureSource Engage mobile application, an ActiGraph activity monitor, and a Bluetooth-enabled weight scale. The […]

Aptevo Therapeutics Presents New Patient-Reported Data With IXINITY

March 12, 2018

SEATTLE, March 12, 2018 (GLOBE NEWSWIRE) — Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, today announced that new patient-reported outcomes data for IXINITY® [Coagulation Factor IX (Recombinant)] were presented at the Thrombosis and Hemostasis 2018 Summit of North America, supporting a positive benefit for IXINITY in patients […]

Reducing the Burden of Data Collection in Oncology Trials

February 28, 2018

Understanding patient reported outcomes (PROs) in oncology clinical trials enables researchers to develop more effective treatments for patients battling this illness. But if it isn’t easy for patients to report their health data, they won’t – so it must be accessible for them. Electronic Clinical Outcome Assessment (eCOA) solutions allow seriously ill cancer patients to […]

Understanding the Benefits of eCOA in Oncology Clinical Trials

February 28, 2018

In this episode, Katie Garner discusses the challenges of oncology clinical trials, and the benefits of implementing eCOA (electronic Clinical Outcome Assessment) solutions. There is also a related eBook on this topic. Reducing the Burden of Data Collection in Oncology Trials Use the link below to access the eBook.