Clinical research

Sesen Bio to Host Conference Call to Review First Quarter Financial Results and to Provide Operational Update Highlighting Positive Progress Towards Demonstrating Analytical Comparability

Retrieved on: 
Monday, May 4, 2020
Oncology, Health, FDA, Clinical trials, Pharmaceutical, Biotechnology, Pharmaceutical industry, Validity, Clinical data management, Clinical research, Quality, Validation, Articles, Business, Vicinium®, Sesen Bio

ET to review operating results for the first quarter ended March 31, 2020.

Key Points: 
  • ET to review operating results for the first quarter ended March 31, 2020.
  • The Company will also provide an update on the progress of manufacturing activities related to demonstrating analytical comparability between clinical batches of Vicinium and validation batches of Vicinium intended for potential future commercial use.
  • To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 3780957.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.

Marinus Pharmaceuticals Provides Business Update and Reports First Quarter 2020 Financial Results

Retrieved on: 
Monday, May 4, 2020
Health, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry, Pharmacology

Marinus is moving forward with plans for its Phase 3 pivotal clinical trial in SE after a constructive end-of-Phase2 meeting with the FDA.

Key Points: 
  • Marinus is moving forward with plans for its Phase 3 pivotal clinical trial in SE after a constructive end-of-Phase2 meeting with the FDA.
  • Ganaxolone administered intravenously for 48 hours, the first 12 hours of which is expected to target a 500 ng/ml serum concentration.
  • Patientenrollment to begin in Q3 2020 and trial sites have already identified and are in process of being readying.
  • Marinus remains on-track to report topline data from the trial in Q3 2020 with no expected material delays due to COVID-19.

Medable Secures $25M Venture Funding to Drive Global Adoption of Decentralized Clinical Trials

Retrieved on: 
Monday, May 4, 2020
Technology, Research, Hospitals, Clinical trials, Software, Biotechnology, Health, Data management, Science, Health, Clinical research, Medical research, Clinical pharmacology, Food and Drug Administration, Pharmaceutical industry, Clinical trials, GSR Ventures, Medable

Medable, Inc. , the leading global platform for decentralized clinical trials, today announced $25 million in funding to accelerate clinical drug development with digital technology, enabling effective new therapies to reach patients faster.

Key Points: 
  • Medable, Inc. , the leading global platform for decentralized clinical trials, today announced $25 million in funding to accelerate clinical drug development with digital technology, enabling effective new therapies to reach patients faster.
  • The company has become a leader in the movement to digitize and virtualize clinical trials.
  • Over the past several years, Medables team has built a modular digital platform-as-a-service that streamlines clinical trials with direct-to-patient technologies.
  • Clinical trials are clearly ripe for disruption, and Medable brings forward the next generation of clinical trial platform technology to streamline new therapy development.

Medicenna Announces Upcoming Presentations at the ASCO Annual Meeting

Retrieved on: 
Monday, May 4, 2020
Health, Articles, Drug discovery, Food and Drug Administration, Clinical research, Design of experiments, Pharmaceutical industry, Clinical trial, Orphan drug

Medicenna's lead IL4-EC, MDNA55, has completed a Phase2bclinical trial for rGBM, the most common and uniformly fatal form of brain cancer.

Key Points: 
  • Medicenna's lead IL4-EC, MDNA55, has completed a Phase2bclinical trial for rGBM, the most common and uniformly fatal form of brain cancer.
  • MDNA55 has been studied in five clinical trials involving 132 patients, including 112 adults with rGBM.
  • MDNA55 has demonstrated compelling efficacy and has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA respectively.
  • This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts.

FDA Approves 54 Emergency INDs for Leronlimab Treatment of Coronavirus – CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible for Participation in Two Ongoing Clinical Trials in U.S. – CytoDyn Targets Enrollment Completion fo

Retrieved on: 
Monday, May 4, 2020
Health, Clinical research, Clinical pharmacology, Medical research, Pharmaceutical industry, Clinical trial, Design of experiments, Food and Drug Administration, Expanded access

CytoDyn has submitted a request to the FDA to grant expanded access, also known as compassionate use, to make leronlimab available for patients not eligible for participation in two ongoing clinical trials for coronavirus infections.

Key Points: 
  • CytoDyn has submitted a request to the FDA to grant expanded access, also known as compassionate use, to make leronlimab available for patients not eligible for participation in two ongoing clinical trials for coronavirus infections.
  • We are equally excited about the prospects for patients should the FDA grant access to leronlimab under the compassionate use program.
  • During this past Saturday, we had to overcome many obstacles for two patients who desperately wanted leronlimab.
  • One patient was in the same hospital that enrolled the first 11 patients and the second was a VIP patient in Los Angeles.

Cantargia IND Application for CAN04 Approved by FDA

Retrieved on: 
Monday, May 4, 2020
Health, Food and Drug Administration, United States Public Health Service, Clinical research, Drug Safety, Pharmaceutical industry

STOCKHOLM, May 4, 2020 /PRNewswire/ -- Cantargia AB today announced that the IND application regarding the antibody CAN04 has been approved by the US FDA.

Key Points: 
  • STOCKHOLM, May 4, 2020 /PRNewswire/ -- Cantargia AB today announced that the IND application regarding the antibody CAN04 has been approved by the US FDA.
  • "Starting clinical development of CAN04 in USA is a key strategic goal for Cantargia which will lead to additional awareness.
  • It is a strength that US FDA has reviewed our documentation and approved clinical activities in the US.
  • The granted IND also enables future activities on regulatory designations aimed at accelerating development of promising drugs",said Gran Forsberg, CEO of Cantargia.

DGAP-News: Newron Reports Top-Line Results from its STARS Study Evaluating Sarizotan in Patients with Rett Syndrome

Retrieved on: 
Monday, May 4, 2020
Health, Medicine, Clinical research, Articles, Clinical trials, RTT, Clinical endpoint, Rett syndrome, Placebo

The STARS (Sarizotan for the Treatment of Apneas in Rett Syndrome) clinical study qualified and enrolled 129 Rett syndrome patients in 14 centres throughout the US, Europe, Asia and Australia for the six-month clinical trial.

Key Points: 
  • The STARS (Sarizotan for the Treatment of Apneas in Rett Syndrome) clinical study qualified and enrolled 129 Rett syndrome patients in 14 centres throughout the US, Europe, Asia and Australia for the six-month clinical trial.
  • Patients received treatment with daily doses of 10 mg and 20 mg of sarizotan, or placebo.
  • The primary endpoint of the STARS study was a percentage reduction in episodes of apnea during waking time compared with placebo.
  • Ravi Anand, M.D., Chief Medical Officer of Newron, commented: "We are very disappointed that the top-line results in the STARS study did not meet the study endpoints.

Global Clinical Trials Review for COVID-19, H1, 2020 - ResearchAndMarkets.com

Retrieved on: 
Friday, May 1, 2020
Infectious diseases, Pharmaceutical, Health, Clinical trials, Health, Clinical research, Medical research, Pharmaceutical industry, Coronaviridae, Clinical trial registration, World Health Organization, Coronavirus, Clinical trials

The "Coronavirus Disease 2019 (COVID-19) Global Clinical Trials Review, H1, 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Coronavirus Disease 2019 (COVID-19) Global Clinical Trials Review, H1, 2020" report has been added to ResearchAndMarkets.com's offering.
  • The clinical trial report, "Coronavirus Disease 2019 (COVID-19) Global Clinical Trials Review, H1, 2020" provides an overview of Hyperthyroidism Clinical trials scenario.
  • Clinical Trial Reports are generated using the publisher's proprietary database - Pharma eTrack Clinical trials database.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.

Kubota Vision Completes Enrollment in the Emixustat Phase 3 Clinical Trial in Patients with Stargardt Disease

Retrieved on: 
Friday, May 1, 2020
Health, FDA, General Health, Clinical trials, Research, Science, Pharmaceutical, Health, Medical research, Clinical research, Design of experiments, Stargardt disease, Placebo-controlled study, Clinical trial, Kubota, Emixustat

Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company has completed subject enrollment in its ongoing Phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.

Key Points: 
  • Kubota Vision Inc. (Kubota Vision), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company has completed subject enrollment in its ongoing Phase 3 clinical trial investigating emixustat hydrochloride (emixustat) in patients with macular atrophy secondary to Stargardt disease.
  • The study is a multi-center, randomized, double-masked, and placebo-controlled phase 3 clinical study in which subjects are randomly assigned to emixustat 10 mg or placebo (2:1 ratio) once daily for 24 months.
  • Dr. Kubota continued, We believe that this clinical trial adds value by accelerating rare disease therapy development.
  • Kubota Vision, the Kubota Vision logo and Kubota are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions.

Premier Research Recognized as a Top CRO By Life Science Leader

Retrieved on: 
Friday, May 1, 2020
Health, Clinical research, Articles, Pharmaceutical industry, Medical research, Clinical pharmacology, Clinical trial, Design of experiments, Contract research organization, CRO

DURHAM, N.C., May 1, 2020 /PRNewswire/ -- Premier Research , the clinical research company that delivers outcome-focused insights which support sponsors in developing life-changing therapies, has been recognized as a 2020 CRO Leadership Award winner in the Life Science Leader program's "Quality (Overall)" category for excellence in clinical trial research.

Key Points: 
  • DURHAM, N.C., May 1, 2020 /PRNewswire/ -- Premier Research , the clinical research company that delivers outcome-focused insights which support sponsors in developing life-changing therapies, has been recognized as a 2020 CRO Leadership Award winner in the Life Science Leader program's "Quality (Overall)" category for excellence in clinical trial research.
  • The CRO Leadership Awards, which spotlight clinical research organizations (CROs) that meet or exceed customer expectations, are issued annually by Life Science Leader and Clinical Leader.
  • ISR's stringent screening processes ensures that only highly qualified decision makers participate in its CRO benchmarking market research.
  • Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.