Design of experiments

PRA Health Sciences and Deep Lens announce strategic relationship to accelerate patient recruitment for precision cancer trials

Friday, September 18, 2020 - 1:30pm

RALEIGH, N.C. and COLUMBUS, Ohio, Sept. 18, 2020 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ: PRAH) and Deep Lens, Inc., announced today a new strategic relationship to accelerate patient access and recruitment for oncology clinical trials.

Key Points: 
  • RALEIGH, N.C. and COLUMBUS, Ohio, Sept. 18, 2020 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ: PRAH) and Deep Lens, Inc., announced today a new strategic relationship to accelerate patient access and recruitment for oncology clinical trials.
  • Using Deep Lens VIPER technology, the patient identification process will be streamlined by instantly analyzing data within electronic health records, pathology systems and genomic profiles to enable matching of cancer patients with suitable clinical trials.
  • Deep Lens is a software company focused on a groundbreaking approach to faster recruitment of the best-suited cancer patients to clinical trials.
  • Growing with sponsors, providers, and strategic partners, Deep Lens challenges the status quo so that patients can get the therapies they want and deserve.

Worldwide Risk-based Monitoring Software Industry to 2026 - Featuring MasterControl, Veeva Systems & Techso Among Others - ResearchAndMarkets.com

Friday, September 18, 2020 - 1:05pm

The "Global Risk-based Monitoring Software Market Analysis 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Risk-based Monitoring Software Market Analysis 2020" report has been added to ResearchAndMarkets.com's offering.
  • The Global Risk-based Monitoring Software market is expected to reach $652.40 million by 2026 growing at a CAGR of 15.3% from 2019 to 2026.
  • Risk-based monitoring (RBM) software is a clinical trial-monitoring method that fulfills regulatory necessities.
  • It employs various tools, platforms and dashboards to identify signals, which indicate potential issues with trial conduct, safety, data integrity, compliance and enrollment.

Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia

Friday, September 18, 2020 - 6:00am

The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.

Key Points: 
  • The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.
  • Actemra is currently being investigated as a potential treatment for COVID-19 associated pneumonia, including in combination with an anti-viral in the Phase III REMDACTA clinical trial.
  • Results from the Phase III COVACTA trial in patients with severe COVID-19 associated pneumonia were released in July.
  • EMPACTA (Evaluating Minority Patients with Actemra) is a Phase III, randomized, double-blind, placebo-controlled multicenter study (EMPACTA, NCT04372186) to evaluate the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 associated pneumonia among patients that are often underrepresented in clinical trials.

Nebulyft® Skincare Device Set to Transform the Anti-Aging Landscape

Thursday, September 17, 2020 - 2:19pm

IRVINE, Calif., Sept. 17, 2020 /PRNewswire/ --Rebeccatech LLC is proud to introduce the Nebulyft, World's 1st MicroRF anti-aging device that's truly non-intrusive.

Key Points: 
  • IRVINE, Calif., Sept. 17, 2020 /PRNewswire/ --Rebeccatech LLC is proud to introduce the Nebulyft, World's 1st MicroRF anti-aging device that's truly non-intrusive.
  • The Nebulyft skincare device utilizes the company's proprietary microRF technology to promote subcutaneous collagen tightening and regrowth.
  • Nebulyft skincare device aims to deliver professional skincare results for home users.The initial clinical trials demo that most users are able to see visible wrinkle reduction with a month.
  • For More information on the Nebulyft device, visit www.nebulyft.com and find Nebulyft on Youtube, Facebook and Instagram.

Atossa Therapeutics Receives Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID

Thursday, September 17, 2020 - 2:30pm

This second group of eight participants received a single escalated dose of either AT-301A (placebo) or AT-301B (active drug).

Key Points: 
  • This second group of eight participants received a single escalated dose of either AT-301A (placebo) or AT-301B (active drug).
  • Based on rapid enrollment in the first half of the study, we expect to complete enrollment in the remainder of the study very quickly.
  • We anticipate that our AT-301 nasal spray will complement any traditional COVID-19 vaccine that may be developed, added Dr. Quay.
  • The ongoing Phase 1 study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups.

Global $22 Billion Leukemia Drug Market to 2025: Partnerships & Collaborations, 633 Clinical Trials, 77 Marketed Drugs, Availability, Dosage & Price Analysis

Thursday, September 17, 2020 - 12:00pm

DUBLIN, Sept. 17, 2020 /PRNewswire/ -- The "Global Leukemia Drug Market, Drug Price, Patent, Dosage & Clinical Trials Insight 2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Sept. 17, 2020 /PRNewswire/ -- The "Global Leukemia Drug Market, Drug Price, Patent, Dosage & Clinical Trials Insight 2025" report has been added to ResearchAndMarkets.com's offering.
  • "Global Leukemia Drug Market, Drug Price, Patent, Dosage & Clinical Trials Insight 2025" offers comprehensive insights on the various clinical and non-clinical parameters responsible for growth of global leukemia drug market.
  • The emergence of new technological innovations in clinical research and drug development methodologies has led to the desired thrust to the market in recent years.
  • There are more than 600 drugs in clinical trials and more than 70 drugs are commercially available in the market.

MediWound Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns

Wednesday, September 16, 2020 - 12:30pm

In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S.
  • Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area.
  • Vericel Corporation (NASDAQ: VCEL) holds an exclusive license for North American commercial rights to NexoBrid.

Galera Therapeutics Announces Dosing of First Patient in a Randomized, Double-Blind Pilot Phase 2 Clinical Trial of GC4419 for COVID-19

Wednesday, September 16, 2020 - 1:00pm

The randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety and efficacy of GC4419 in improving 28-day mortality, compared to placebo.

Key Points: 
  • The randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety and efficacy of GC4419 in improving 28-day mortality, compared to placebo.
  • The trial will enroll up to 50 hospitalized adult patients critically ill with COVID-19 at several sites across the U.S.
  • Patients in the trial will receive 90 mg of GC4419 or placebo by infusion twice daily for seven days.
  • The trial will also collect additional data related to the requirement for intensive care, mechanical ventilation, and organ function.

Company Profile for Anova Enterprises, Inc.

Wednesday, September 16, 2020 - 10:59am

Anova is a technology company bringing participants in the clinical research process together to speed promising new treatments to market, at reduced cost and for a larger number of patients.

Key Points: 
  • Anova is a technology company bringing participants in the clinical research process together to speed promising new treatments to market, at reduced cost and for a larger number of patients.
  • We kickstart the development of new treatments through standardization and automation as no one else can do.

DGAP-News: Positive Results from Adrenomed's AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented during e-ISICEM

Wednesday, September 16, 2020 - 7:00am

[1]

Key Points: 
  • [1]
    The AdrenOSS-2 Phase II trial ( NCT03085758 [2] ) achieved its primary endpoint: No differences in serious or possibly related Treatment Emergent Adverse Events (TEAEs) between Adrecizumab and placebo were observed.
  • As already demonstrated in previous Phase I trials, Adrecizumab exhibited a favorable safety and tolerability profile in septic shock patients.
  • [3]
    28-day all-cause mortality analysis including all patients (n=301) showed a trend towards a survival benefit for Adrecizumab treated patients.
  • Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock.