Outcome (probability)

Ventura Orthopedics and OBERD partner for Patient Reported Outcomes data collection

Retrieved on: 
Thursday, January 5, 2023

COLUMBIA, Mo., Jan. 5, 2023 /PRNewswire/ -- Ventura Orthopedics will partner with OBERD for digital Patient-Reported Outcomes collection.

Key Points: 
  • COLUMBIA, Mo., Jan. 5, 2023 /PRNewswire/ -- Ventura Orthopedics will partner with OBERD for digital Patient-Reported Outcomes collection.
  • As one of the leading orthopedic specialty institutions on the west coast, Ventura Orthopedics has a strong commitment to improving the patient experience and utilizing data to improve outcomes.
  • OBERD's sophisticated technology will help Ventura Orthopedics engage patients electronically to capture as much meaningful data as possible.
  • Integrating OBERD into Ventura Orthopedics' clinical flow will result in minimal workflow disruption – a benefit that appealed greatly to Ventura Orthopedics during its evaluation process.

Veeva Introduces New ePRO Application for Faster Access to Patient Data

Retrieved on: 
Tuesday, October 18, 2022

BARCELONA, Spain, Oct. 18, 2022 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced the availability of Veeva ePRO, a key advancement in patient-centric digital trials. The application makes it easier for patients to complete assessments on a mobile device or web browser and enables real-time data access for sponsors and clinical research sites. As part of a connected platform for clinical trials, study teams can use ePRO to exchange high-quality data across the clinical ecosystem for improved transparency and collaboration.

Key Points: 
  • BARCELONA, Spain, Oct. 18, 2022 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced the availability of Veeva ePRO , a key advancement in patient-centric digital trials.
  • The application makes it easier for patients to complete assessments on a mobile device or web browser and enables real-time data access for sponsors and clinical research sites.
  • As part of a connected platform for clinical trials, study teams can use ePRO to exchange high-quality data across the clinical ecosystem for improved transparency and collaboration.
  • Veeva ePRO is part of Veeva Vault Clinical Suite , the industry's first cloud platform that unifies clinical data management and operations.Vault Clinical Suite includes Vault EDC , Veeva RTSM , Veeva ePRO, Veeva CDB , Vault eTMF , Vault CTMS , Veeva Site Connect , Vault Payments , Vault Study Start-up , and Vault Study Training .

Treace Announces Updated ALIGN3D™ Data at the 2022 AOFAS Annual Meeting

Retrieved on: 
Tuesday, September 13, 2022

John T. Treace, CEO, Founder and Board Member of Treace said, Interim data readouts from our ongoing ALIGN3D clinical study continue to demonstrate sustained, successful procedural and patient outcomes on additional patients followed through 12-, 24- and 36-months post-surgery.

Key Points: 
  • John T. Treace, CEO, Founder and Board Member of Treace said, Interim data readouts from our ongoing ALIGN3D clinical study continue to demonstrate sustained, successful procedural and patient outcomes on additional patients followed through 12-, 24- and 36-months post-surgery.
  • The audio poster, which includes additional details, can be accessed by meeting attendees on a kiosk at the Annual Meeting or on the mobile app.
  • The updated data is also available on the Treace Medical website.
  • The AOFAS Annual Meeting is the premier event for foot and ankle education, offering presentations from renowned speakers, special interest forums and the latest products and technology.

AIM ImmunoTech Bolsters Intellectual Property Portfolio for Ampligen® with Issuance of New Netherlands Utility Patent Covering Ampligen® and other AIM Developed dsRNA Products for Use in COVID-19 Treatment or Prevention

Retrieved on: 
Monday, June 13, 2022

2027383 a utility patent covering Ampligen (rintatolimod) and other AIM developed dsRNA products for use in the prevention or treatment of COVID-19, with a base patent term extending until 2041.

Key Points: 
  • 2027383 a utility patent covering Ampligen (rintatolimod) and other AIM developed dsRNA products for use in the prevention or treatment of COVID-19, with a base patent term extending until 2041.
  • Ampligen is AIMs RNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.
  • In another patent embodiment, the therapeutic double-stranded RNA product may be one or more of a number of therapeutic double-stranded RNA (tdsRNA) developed by AIM.
  • National patent application filings based on these PCTs, entitled to claim priority from the provisional patent applications, are ongoing.

SpringWorks Therapeutics Announces Nirogacestat Achieved Primary and All Key Secondary Endpoints in Phase 3 DeFi Trial in Adult Patients with Progressing Desmoid Tumors

Retrieved on: 
Tuesday, May 24, 2022

-- NDA Submission to the U.S. FDA Planned for Second Half of 2022 --

Key Points: 
  • In addition, the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate (ORR) and patient-reported outcomes (PROs).
  • Desmoid tumors are aggressive soft-tissue tumors that can lead to severe negative outcomes for patients, including long-lasting pain, disfigurement, and amputation.
  • In rare cases, when vital organs are impacted, desmoid tumors can also be life-threatening, said Saqib Islam, Chief Executive Officer of SpringWorks.
  • DeFi ( NCT03785964 ) is an ongoing, global, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors.

AIM ImmunoTech Provides Update on Ampligen Long COVID Development Program

Retrieved on: 
Wednesday, May 18, 2022

Long COVID also referred to as Post-COVID conditions by the U.S. Centers for Disease Control and Prevention (CDC) presents as a wide range of health problems.

Key Points: 
  • Long COVID also referred to as Post-COVID conditions by the U.S. Centers for Disease Control and Prevention (CDC) presents as a wide range of health problems.
  • A Phase 3 prospective, double-blind, randomized, placebo-controlled trial of rintatolimod (Ampligen) in ME/CFS (AMP-516) produced objective improvement in exercise tolerance.
  • We are hopeful about the potential of the drug Ampligen in Long COVID and ME/CFS.
  • Significant additional testing and trials will be required to determine whether Ampligen will be an effective treatment for Long COVID.

Treace Announces Peer-Reviewed Publication of ALIGN3D™ Multicenter Prospective Clinical Data

Retrieved on: 
Thursday, May 5, 2022

Additionally, statistically significant improvement in physical, mental, and social health scores were reported using the PROMIS-29 scoring system.

Key Points: 
  • Additionally, statistically significant improvement in physical, mental, and social health scores were reported using the PROMIS-29 scoring system.
  • John T. Treace, CEO, Founder and Board Member of Treace said, We are pleased to announce our first ALIGN3D peer-reviewed publication in the Journal of Foot & Ankle Surgery reporting on the studys one- and two-year results.
  • This type of multicenter, prospective study is unique in the field of bunion surgery, and this positive interim data documents successful patient outcomes utilizing our proprietary Lapiplasty Procedure.
  • The ALIGN3D clinical study is a prospective, multicenter, post-market study designed to evaluate outcomes of Lapiplasty 3D Bunion Correction in the surgical management of symptomatic hallux valgus.

Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients

Retrieved on: 
Thursday, April 28, 2022

Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives.

Key Points: 
  • Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives.
  • For more information, please visit viforpharma.com
    Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.
  • The Companys novel KORSUVA (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
  • 4 Mathur VS, et al.A longitudinal study of Uremic Pruritus in hemodialysis patients.Clin J Am Soc Nephrol.2010; 5(8):1410-1419.

Kapruvia® receives positive CHMP opinion for the treatment of moderate-to-severe pruritus in hemodialysis patients

Retrieved on: 
Friday, February 25, 2022

Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives.

Key Points: 
  • Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives.
  • For more information, please visit viforpharma.com
    Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.
  • The Companys novel KORSUVA (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
  • 4 Mathur VS, et al.A longitudinal study of Uremic Pruritus in hemodialysis patients.Clin J Am Soc Nephrol.2010; 5(8):1410-1419.

Kapruvia® receives positive CHMP opinion for the treatment of moderate-to-severe pruritus in hemodialysis patients

Retrieved on: 
Monday, February 28, 2022

The CHMP opinion is the basis for the European Commissions final decision regarding marketing authorization for Kapruvia.

Key Points: 
  • The CHMP opinion is the basis for the European Commissions final decision regarding marketing authorization for Kapruvia.
  • If approved, Kapruvia will be the first therapy available in Europe for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients.
  • We are pleased to have received the positive CHMP opinion, which brings us one step closer to making a treatment option available to hemodialysis patients in Europe who suffer from pruritus, said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics.
  • These are major milestones on Cara Therapeutics path to being a category-defining leader in the treatment of pruritus.