Clinical Trials (Phase IV)
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Santhera Announces Phase 4 LEROS Trial with Raxone® Met Primary Endpoint in Patients with Leber’s Hereditary Optic Neuropathy
6/23/2021
Santhera Pharmaceuticals announces positive topline results from itslong-term Phase 4 LEROS study with Raxone® in the treatment of Leber’s hereditary optic neuropathy.The primary endpoint, proportion of eyes with clinically relevant benefit after 12 months treatment with Raxone versus untreated patients from an external control group, was met with high statistical significance.
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Eli Lilly and Company announced Tuesday the launch of a head-to-head study to compare once-monthly injectable Emgality® (galcanezumab-gnlm) with Nurtec® ODT (rimegepant) for the prevention of migraine.
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The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.
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Bharat will conduct Phase IV studies to check real-world efficacy against the virus, while Ocugen says Covaxin will be a valuable tool in helping to end the COVID-19 pandemic.
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Embossed NPWT Dressing Successfully Completes Clinical Safety Study
4/15/2021
"Utilization of a Novel Negative Pressure Platform Wound Dressing on Surgical Incisions: A Case Series"
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Ardelyx Announces Upcoming Data Presentation at ISN World Congress of Nephrology 2021
4/12/2021
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it will present a poster highlighting data from NORMALIZE, an ongoing Phase 4 trial
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Green Park Collaborative and Allergy & Asthma Network Publish a Core Outcome Set for Clinical Trials in Moderate to Severe Asthma
4/6/2021
The Green Park Collaborative (GPC), a major initiative of the Center for Medical Technology Policy (CMTP), in partnership with Allergy & Asthma Network (AAN), led a stakeholder consensus initiative to recommend outcomes that should be core across all phase 3 and 4 clinical drug trials for moderate to severe asthma.
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Bayer Announces Publication of Phase IV Adempas® (riociguat) Data in The Lancet Respiratory Medicine
3/29/2021
Bayer Announces Publication of Phase IV Adempas ® (riociguat) Data in The Lancet Respiratory Medicine The prospective, randomized, controlled, open-label study, which included outcomes from 226 patients with pulmonary arterial hypertension (PAH) (WHO Group 1), met its primary endpoint
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Chemistree Investee - ImmunoFlex Receives NRC IRAP Funding
2/8/2021
Chemistree Technology Inc. (CSE: CHM) (CSE: CHM.WT) (OTCQB: CHMJF) is pleased to inform shareholders that Chemistree investee ImmunoFlex™ has today announced that it is receiving advisory services and conditional research and development funding from the National Research Council
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VBI Vaccines Announces Publication of Results from a Phase 4 Study of VBI’s Prophylactic 3-Antigen Hepatitis B Vaccine in Vaccine
1/15/2021
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that results from a Phase 4 study of VBI’s prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier
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Biogen Announces First Patient Treated in RESPOND Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated With Zolgensma® (onasemnogene abeparvovec)
1/8/2021
Biogen Inc. (Nasdaq: BIIB) today announced that the first patient has been treated in the global clinical study, RESPOND. The Phase 4 study will examine the clinical benefit and assess the safety of SPINRAZA® (nusinersen) in infants and children with spinal muscular atrophy (SMA) who still have unmet clinical needs following treatment with gene therapy Zolgensma
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Medexus Reaches 50% Enrollment in IXINITY® Phase 4 Clinical Trial Targeting Label Expansion for Pediatric Hemophilia B Patients
11/16/2020
Medexus Pharmaceuticals Inc. (the “Company” or “Medexus” ) ( TSXV: MDP , OTCQ X : MEDXF ) today announced it has reached the 50% enrollment target in its Phase 4 clinical trial investigating IXINITY® as a prophylactic treatment for pediatric patients under 12 years of age with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX. IXINITY is an FDA approved in
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Wize Pharma Announces Positive Topline Results in Phase IV Study of LO2A for the Treatment of Dry Eye Syndrome in Patients with Sjögren's Syndrome
11/12/2020
Wize Pharma, Inc. (OTCQB: WIZP), a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, today reported topline results from its Phase IV clinical trial of its in-license eye drop formula, LO2A, for the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren's syndrome.
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Bayer Phase IV Study Met its Primary Endpoint in PAH Patients Who Had Transitioned to Adempas® (riociguat) After Insufficient Response to PDE5 Inhibitors
9/7/2020
Outcomes from the randomized, controlled, open-label REPLACE study included results from 226 patients with pulmonary arterial hypertension (PAH)
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Biogen Plans to Initiate Phase 4 Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated with Zolgensma® (onasemnogene abeparvovec)
7/21/2020
In the long-term follow-up study of Zolgensma ® and real-world experience, it has been reported that some patients previously treated with gene therapy have been treated with SPINRAZA 1,2,3 The RESPOND study aims to evaluate the efficacy and safety of SPINRAZA in patients with a suboptimal clinical response to Zolgensma Biogen continues to advance research in spinal muscular atrophy to address the needs of the community and provide additional data to inform treatment decisions CAMBRIDGE,
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On International Kissing Day, The Restylane® Brand Shares First-of-its-Kind Phase IV Kissability Study Results Showing Both Subject and Partner Satisfaction with Restylane® Kysse
7/6/2020
The Restylane® brand today announced results of a first-of-its-kind phase IV, Kissability study for an injectable hyaluronic acid (HA) lip filler, evaluating not only subject satisfaction but, for the first time, partner satisfaction following treatment with Restylane® Kysse
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Medicure Announces Positive Results for AGGRASTAT in the FABOLUS-FASTER Trial and Publication in the Journal - Circulation
6/29/2020
Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a pharmaceutical company, today announced that results from the investigator sponsored FABOLUS-FASTER Phase 4 clinical trial, using AGGRASTAT®, have been published in Circulation, a peer-reviewed journal of the American Heart Association.
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Medicure Announces Top Line Data from FABOLUS-FASTER Trial With AGGRASTAT will be Presented at the PCR e-Course, Late Breaking Trial Sessions, June 27, 2020
6/15/2020
Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, is pleased to announce that on Saturday, June 27, 2020, Dr. Marco Valgimigli, MD, PhD, Professor of Cardiology, Director of Clinical Research at Bern University Hospital, will present the results of the FABOLUS-FASTER Phase 4 clinical trial.
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Decentralized clinical trials gained a foothold in the pharmaceutical industry amidst the COVID-19 pandemic and will continue to be used once the pandemic ends, according to panelists at BIO 2020, speaking Thursday in a virtual session.
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Although clinical trials are often performed throughout different parts of the world, often their demographic makeup—the gender, age and race of participants—has a certain kind of uniformity.