Clinical Trials (Phase III)
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After nearly a month in limbo, AstraZeneca will resume Phase III testing of its COVID-19 vaccine candidate in the United States.
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Two Phase III studies showed significant reduction in urinary oxalate excretion in patients of all ages with PH1.
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Study Suggests Bayer’s Finerenone Slows CKD Progression in Patients With Kidney Disease and T2D
10/23/2020
The findings from this study were presented at the virtual American Society of Nephrology’s (ASN) Kidney Week 2020 on October 23, and the full study was published in a recent online edition of the New England Journal of Medicine. -
Akebia Presents Results from its PRO2TECT Global Phase 3 Program of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients Not on Dialysis
10/23/2020
Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced the presentation of clinical data from its PRO2TECT global Phase 3 program that evaluated the efficacy and safety of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
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Bayer’s FIDELIO-DKD Phase III Study Demonstrated Investigational Drug Finerenone Significantly Reduced Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes
10/23/2020
Finerenone is a potential first-in-class investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that works on the pathway of MR overactivation, a key contributor to disease progression in patients with chronic kidney disease and type 2 diabetes FIDELIO-DKD is the first large contemporary positive outcomes study in patients with chronic kidney disease and type 2 diabetes with a primary composite endpoint exclusively cons
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BiondVax Announces Topline Results from Phase 3 Clinical Trial of the M-001 Universal Influenza Vaccine Candidate
10/23/2020
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a pioneer in the development of a universal flu vaccine designed to provide protection against current, future, seasonal and pandemic influenza, today announced topline data from the Company's pivotal, phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate.
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FARXIGA DAPA-CKD Phase III Trial Reduced Worsening of Kidney Function, Risk of Cardiovascular or Renal Death in Patients With Chronic Kidney Disease Irrespective of Underlying Cause
10/23/2020
FARXIGA DAPA-CKD Phase III Trial Reduced Worsening of Kidney Function, Risk of Cardiovascular or Renal Death in Patients With Chronic Kidney Disease Irrespective of Underlying Cause Results reinforce FARXIGA’s potential to treat a wide range of patients with chronic kidney disease WILMINGTON, Del.--( BUSINESS WIRE )-- A new subgroup analysis from the ground-breaking DAPA-CKD Phase III trial showed that AstraZeneca’s FARXIGA ® (dapagliflozin), on
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First Patient Dosed in Monalizumab Phase 3 Clinical Trial Triggers $50M Payment From AstraZeneca
10/23/2020
INTERLINK-1 represents first Phase 3 study examining IO approach in R/M SCCHN patients who have been treatedwith a platinum-based therapy and PD-(L)1 inhibitor
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Moderna Fully Enrolls 30,000-Person COVID-19 Vaccine Trial, Boosts Minority Participation
10/22/2020
Moderna has fully enrolled its late-stage coronavirus disease 2019 (COVID-19) vaccine trial by hitting its target of 30,000 participants. More than one-third of this cohort includes minority participants. -
Aurinia Pharmaceuticals selects MyMeds&Me’s Reportum QuickStart platform to streamline drug safety reporting
10/22/2020
MyMeds&Me, a leading provider of drug safety software to transform the end-to-end pharmacovigilance process, have today announced that Aurinia Pharmaceuticals Inc. (Aurinia) has selected the Reportum QuickStart platform to streamline the capture, processing and management of safety data for the investigational drug voclosporin, following recent positive Phase 3 results.
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Milestone Pharmaceuticals Announces Proposed Public Offering of Common Shares and Pre-Funded Warrants
10/22/2020
Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing etripamil for the treatment of cardiovascular indications, today announced that it intends to offer and sell common shares and, to certain investors in lieu thereof, pre-funded warrants to purchase common shares, in an underwritten public offering
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Orbus Therapeutics Expands Series A Financing to $71 Million to Support Ongoing STELLAR Phase 3 Study in Rare Brain CancerProceeds to fund STELLAR study and additional clinical studies in patients with malignant gliomas
10/22/2020
Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that that it has closed an expansion of its Series A financing. As part of this expanded financing, Abingworth LLP has joined the existing Series A investors led by Longitude Capital, H.I.G. BioVentures and Adams Street Partners. In conjunction with the financing, Kur
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Akebia Presents Results from its INNO2VATE Global Phase 3 Program; Demonstrated Efficacy and Cardiovascular Safety of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis
10/22/2020
- INNO2VATE data presented at American Society of Nephrology Kidney Week 2020 Reimagined - Presentation expands on previously announced positive top-line data showing vadadustat achieved clear and consistent results across primary and secondary efficacy and safety endpoints - Company on track to submit New Drug Application - Company to host investor briefing webcast at 4:10 p.m. ET on October 23, 2020
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Soligenix Announces Phase 3 FLASH Study Continues to Demonstrate Positive Benefits in Patients with Cutaneous T-Cell Lymphoma
10/22/2020
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3)
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Alnylam Presents Positive Results from ILLUMINATE-B Phase 3 Study in Pediatric Patients with Primary Hyperoxaluria Type 1 at the American Society of Nephrology Kidney Week
10/22/2020
– Lumasiran Demonstrated a 72 Percent Mean Reduction in Urinary Oxalate and Improvements in Nephrocalcinosis in ILLUMINATE-B Phase 3 Study in Children Under the Age of Six and as Young as Three Months – – Alnylam Also Presents New Results from the 12-Month Extension Period of the ILLUMINATE-A Pivotal Study,
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FibroGen Presents Late-Breaker Abstract Results on Associations between Hemoglobin Levels and Cardiovascular Outcomes in Roxadustat-Treated Patients with Anemia of Chronic Kidney Disease (CKD)
10/22/2020
In non-dialysis and dialysis-dependent CKD patients, Major Adverse Cardiovascular Event (MACE) and MACE+ incidence rates were lowest when patients achieved hemoglobin levels ≥ 1 0 g/dL Two analyses o f pooled data from the roxadustat global Phase 3 development program t o be presented during the American Society of Nephrology Kidney Week 2020 Reimagined
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Moderna Completes Enrollment of Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273)
10/22/2020
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has completed enrollment of 30,000 participants for the Phase 3 COVE study of mRNA-1273, its vaccine candidate against COVID-19, being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
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AstraZeneca Shares Drop Following Report of a COVID-19 Vaccine Study Patient Death in Brazil
10/21/2020
Shares of AstraZeneca dropped slightly Wednesday afternoon following reports that a patient participating in the Brazilian arm of the company’s global Phase III study has died. -
The U.S. arm of the trial has been paused for more than a month while the U.S. Food and Drug Administration investigates a serious illness that occurred in a patient who received the experimental treatment.
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Cara Therapeutics Announces Presentation at American Society of Nephrology Kidney Week 2020
10/21/2020
Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, today announced that results from its KALM-2 pivotal Phase 3 trial of KORSUVA