Clinical Trials - Phase IV
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A CRA’s Digital Journey, aka How I Learned to Love my eTMF
10/30/2019
As a consultant CRA with more than a decade of experience, I took on the assignment of managing the essential TMF documents for two large phase 3 dermatology studies in 2007 thinking “This won’t be so bad!”
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SureClinical and Clinilabs Announce Global Lunch and Learn Series for Clinical Operations
10/17/2019
SureClinical, a global provider of innovative cloud solutions for the health sciences market and Clinilabs Drug Development Corporation, a CNS-focused contract research organization, are sponsoring a global Lunch & Learn series demonstrating how sponsors can streamline and accelerate the clinical trials process.
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Cannabics Pharmaceuticals Announces Publication of Clinical Data From Its Sponsored Pilot Study on Controlled Release Capsules, on the Journal of Integrative Cancer Therapies
10/16/2019
Data Demonstrated Cannabics' SR capsules with 5 mg dosage seems to be appropriate for the treatment of cancer anorexia-cachexia syndrome (CACS) in advanced cancer patients under active treatment.
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Galmed Pharmaceuticals Initiated ARMOR, a Phase 3/4 Registrational Study of Aramchol in Subjects With NASH and Fibrosis
9/26/2019
Galmed Pharmaceuticals Ltd. announced the initiation of its Phase 3/4 ARMOR clinical study to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis.
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While the Danish drugmaker’s Tresiba (insulin degludec) didn’t fare as well as hoped in the head-to-head trial, Novo Nordisk was quick to point out that Tresiba showed an overall lower risk of hypoglycemia compared to Toujeo.
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Results from Blue Earth Diagnostics’ FALCON Trial Show 64% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Following Axumin® (Fluciclovine F 18) PET/CT Scan
9/16/2019
Results presented at ASTRO Annual Meeting evaluate clinical utility of 18F-fluciclovine PET/CT imaging in men with recurrent prostate cancer
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Fractyl Announces Positive Topline Results in the Revita-2 Clinical Trial in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
9/9/2019
Successful completion of Fractyl’s first sham-controlled, multicenter clinical trial of Revita DMR to support EU commercial launch and inform U.S. pivotal clinical trial
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REVIAN® RED Light Therapy Safe and Effective for Hair Growth
9/4/2019
New Trial Data Shows Favorable Results Compared to Data Published for Directly Competing Hair Loss Treatments
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Atlantic Research Group Opens New European Offices
8/27/2019
Atlantic Research Group (ARG), a full-service global contract research organization (CRO), has opened new European offices in Amsterdam and Warsaw. The corporate offices, combined with an existing London location, strengthen ARG’s global operations and set the stage for continued growth.
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“It’s important to recognize that this problem is there and this problem is persisting over the years,” Kanwal Raghav, author of the study and an oncologist at MD Anderson Cancer Center, told STAT.
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Clinical Catch-up for August 12-16
8/19/2019
As summer winds its way to an end, biopharmaceutical companies continue to conduct clinical trials and release news related to them. Here’s a look at last week’s clinical trial headlines. -
Patients who took Taltz in the post-marketing study achieved higher rates of “complete skin clearance” in comparison to Tremfya as measured by PASI 100. -
Lilly Announces Superiority of Taltz® (ixekizumab) versus TREMFYA® (guselkumab) in Delivering Total Skin Clearance at Week 12 in Topline Results from Head-to-Head (IXORA-R) Trial in People Living with Moderate to Severe Plaque Psoriasis
8/13/2019
IXORA-R is the first Phase 4 head-to-head study comparing efficacy between an IL-17A inhibitor and an IL-23/p19 inhibitor using PASI 100 as the primary endpoint
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Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis
7/30/2019
Alkermes plc and Biogen Inc. announced positive topline results from EVOLVE-MS-2, a large, randomized, double-blind, five-week, Phase 3 study of diroximel fumarate, an investigational, novel oral fumarate with a distinct chemical structure, for relapsing-remitting multiple sclerosis, compared to TECFIDERA®.
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In its third installment of the Good Pharma Scorecard, Roche and Novo Nordisk scored perfect marks in overall trial transparency, while Johnson & Johnson slipped from the high spot on the previous ranking.
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The beginning of virtual clinical trials is going to be a game-changer. Why they are going to be game-changer? What changes will occur? Know it all here. -
Help us identify the leading employers in the life science industry! We want to uncover who leads in key areas like diversity, culture, unique benefits and, of course, who are the 2019 Life Sciences Ideal Employers.
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Pfizer Announces Positive Top-Line Results from Phase 4 Study of Crisaborole Ointment, 2%, in Children Aged 3 Months to Less Than 24 Months with Mild to Moderate Atopic Dermatitis
7/1/2019
Pfizer Inc. (NYSE:PFE) today announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema.
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ROADSTER-2 Demonstrates Compelling Patient Outcomes with Strong Safety Profile
6/15/2019
Final Results Presented in Late-Breaking Session at Society for Vascular Surgery 2019 Vascular Annual Meeting
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Lilly Presents Positive Results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis at the European Congress of Rheumatology
6/14/2019
Eli Lilly and Company announced that the company will present positive findings from the Phase 3b/4 SPIRIT-Head-to-Head study in patients with active psoriatic arthritis as a late-breaking abstract at the European Congress of Rheumatology in Madrid, Spain on June 15.