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Biotechnology Products Clinical Trials

05:32 EST 23rd January 2019 | BioPortfolio

Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs

In Canada and worldwide there is a need for updated independent real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs. Biosimilar drugs hold potential to improve access to needed therapies at reduced cost enabling savings to be reallocated to other needs. However updated real-world evidence on comparative effectiveness and...

Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer

This study is a multicenter, prospective, single-arm, phase II study to evaluate the antitumor activity and safety of trastuzumab biosimilar (herzuma®) plus gedatolisib in patients with HER-2 positive MBC who progressed after 2 or more HER-2 directed chemotherapy.

An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease

The purpose of this program is to provide early access to ustekinumab where it is commercially unavailable for the treatment of participants with moderately to severely active Crohn's disease who have failed treatment with conventional Crohn's disease therapy (example, immunomodulators or corticosteroids) and Tumor Necrosis Factor alpha (TNF alpha) antagonist therapy (e.g.,...

Post-ASCT Use of Zarzio®

There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and Ratiograstim®) compared to those of Neupogen® for our patients who underwent ASCT.

An Explanatory Factors Analysis of Inflammatory Bowel Diseases(IBD's) Management Costs for Adults Patients Treated by Biotherapy and Followed at Nancy University Hospital

The objective of this study is to analyze the factors influencing the medical and non-medical direct costs of patients treated with biotherapy during the last twelve months (infliximab or adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for treating Crohn's desease or ulcerative colitis

A Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Injections of Elamipretide (MTP-131) in Subjects With Genetically Confirmed Mitochondrial Disease Previously Treated in the Stealth BioTherapeutics SPIMM-201 Study

This is a Phase 2, randomized, double-blind, placebo-controlled crossover study which will enroll up to 36 subjects (anticipated) with genetically confirmed mitochondrial disease who have completed participation in the SPIMM-201 (MMPOWER) study. Subjects will be randomized (1:1) to one of two sequence groups: 4-weeks of treatment with 40 mg elamipretide administered once da...

A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine

Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluat...

Personalized Immunotherapeutics for Antibiotic-resistant Infection

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and ...

The Effect of OASIS Ultra on Critical Sized Wound Healing

The aim of this study is to evaluate the speed and quality with which OASIS® Ultra (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical sized defect. The investigators intend on confirming the histological composition of the dermal substitute in order to delineate the amount of cellular recruitment, collagen deposition and neovasculari...

Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)

The purpose of this study is to: - evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360 mg/kg total IgG, GAMUNEX(R)(immune globulin intravenous (human) 10% caprylate/chromatography purified). GAMUNEX is a trademark o...

Nicotine Vaccination and Nicotinic Receptor Occupancy

This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a t...

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