National Institute for Health and Care Excellence

Healthcare Veteran, Zach Henderson to lead Global Kinetics as CEO

Retrieved on: 
Wednesday, May 3, 2023

Zach joins Global Kinetics with over 25 years of healthcare software and big data experience and will lead Global Kinetics' continued growth and global expansion.

Key Points: 
  • Zach joins Global Kinetics with over 25 years of healthcare software and big data experience and will lead Global Kinetics' continued growth and global expansion.
  • Zach recently served as the Chief Commercial Officer of Glooko, where he led the rapid growth of the business with life science partners and healthcare providers.
  • "With the largest body of published clinical evidence and over 35,000 patients treated, Global Kinetics has the deepest clinical data set in the neurology field," said Zach Henderson, newly appointed CEO of Global Kinetics.
  • Mr. Henderson's appointment as CEO follows several exciting announcements for Global Kinetics.

Aurinia Pharmaceuticals Announces NICE Recommendation of LUPKYNIS® (Voclosporin) For Adults with Active Lupus Nephritis

Retrieved on: 
Wednesday, May 3, 2023

The NICE recommendation applies to England and Wales and follows the recent Medicines and Healthcare Products Regulatory Agency (MHRA) authorization of voclosporin licensed in Great Britain for the treatment of active LN in adult patients.

Key Points: 
  • The NICE recommendation applies to England and Wales and follows the recent Medicines and Healthcare Products Regulatory Agency (MHRA) authorization of voclosporin licensed in Great Britain for the treatment of active LN in adult patients.
  • “We are extremely pleased with the NICE recommendation of LUPKYNIS for patients with lupus nephritis.
  • This recommendation follows the earlier approval from the MHRA and further supports access to an important treatment option for those patients.
  • The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.

Carpal Tunnel Release System - Market Insights, Competitive Landscape and Market Forecast 2023-2027: Increasing Prevalence of Carpal Tunnel Syndrome Among Women Boosts Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 25, 2023

The Carpal Tunnel Release System Market is estimated to register a growth at a remarkable CAGR forecast during 2022-2027 owing to rising cases of workplace associated carpal tunnel syndrome and increasing prevalence of carpal tunnel syndrome among women.

Key Points: 
  • The Carpal Tunnel Release System Market is estimated to register a growth at a remarkable CAGR forecast during 2022-2027 owing to rising cases of workplace associated carpal tunnel syndrome and increasing prevalence of carpal tunnel syndrome among women.
  • Carpal Tunnel Release System Market Dynamics:
    The rising cases of workplace-associated carpal tunnel syndrome is one of the noteworthy driver for the carpal tunnel release system market.
  • Carpal Tunnel Release System Market Segment Analysis:
    Carpal Tunnel Release System Market by Type (Endoscopic Carpal Tunnel Release System and Open Carpal Tunnel Release System), End-User (Hospitals, Ambulatory Surgical Centres, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World).
  • Moreover, the technique of the open carpal tunnel release system has been improved throughout time with the introduction of mini-open carpal tunnel release systems and ultrasound-guided carpal tunnel release.

Adverum Biotechnologies Granted Innovative Licensing and Access Pathway Designation in the United Kingdom for Ixo-vec for the Treatment of Wet AMD

Retrieved on: 
Tuesday, April 18, 2023

REDWOOD CITY, Calif., April 18, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Ixo-vec (ixoberogene soroparvovec), an investigational gene therapy for the treatment of wet AMD, an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP). The Innovation Passport is the first step in the ILAP process, triggering the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE) and the National Health Service (NHS) England, to partner with Adverum to charter a roadmap for regulatory and development milestones with the goal of early patient access in the United Kingdom (U.K.)

Key Points: 
  • The OPTIC data indicates a greater than 80% reduction in annualized anti-VEGF injections with more than 50% of the trial subjects being supplemental injection-free at two years post-treatment with Ixo-vec, which data is suggestive of a functional cure,” commented Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • “The current standard of care in wet AMD, requires frequent anti-VEGF injections in the eye that can be a lifelong burden for many patients and their caregivers.
  • We believe Ixo-vec has the potential to provide an in-office treatment option that is durable and safe, provides cost-savings, and addresses the needs of wet AMD patients and their families, retina specialists and health systems worldwide.
  • We look forward to leveraging the benefits of ILAP designation, as we continue our development of Ixo-vec.”
    “The ILAP designation grants us enhanced regulatory and market access interactions and a potentially faster path towards approval in the U.K. Ixo-vec has already received Fast Track Designation by the FDA and PRIME designation by the EMA,” said Star Seyedkazemi, PharmD, chief development officer of Adverum Biotechnologies.

Global Vitamin in Human Nutrition Market Report to 2028: Rising Number of Health-conscious Consumers Drives Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, April 17, 2023

The market for vitamins in human nutrition is expected to be driven by a rise in the number of health-conscious consumers and a preference for vitamins in daily diets.

Key Points: 
  • The market for vitamins in human nutrition is expected to be driven by a rise in the number of health-conscious consumers and a preference for vitamins in daily diets.
  • The Global Vitamin in Human Nutrition Market is segmented based on Type, Application, end use, distribution channel, and Region.
  • Based on the Type, the Global Vitamin in Human Nutrition Market is segmented as Multivitamin, Vitamin A, Vitamin B, Vitamin C, Vitamin E, Vitamin D, Vitamin K.
    Based on the Application, the Global Vitamin in Human Nutrition Market is segmented as Dietary Supplements, Functional Nutrition, Sports Nutrition, Infant Nutrition.
  • The global market for human nutrition is predicted to grow as a result of the emergence of a middle class with high incomes in the emerging vitamin market.

Uterine Fibroids Impact Up to 70% of African American Women Over the Age of 50

Retrieved on: 
Saturday, April 15, 2023

San Diego, April 15, 2023 /PRNewswire-PRWeb/ -- Precision Therapy provides outpatient fibroid treatment in San Diego to host virtual event!

Key Points: 
  • Up to 40% of women over the age of 35 have uterine fibroids, and that number increases to over 70% of women over 50.
  • African American women are three times more likely to have fibroids than women of other ethnicities.
  • Up to 40% of women over the age of 35 have uterine fibroids, and that number increases to over 70% of women over 50.
  • African American women are three times more likely to have fibroids than women of other ethnicities.

MHRA Grants ADvantage Therapeutics Innovative Licensing and Access Pathway (ILAP) Designation for Novel Lead Product AD04™ for Phase 2b Trial in Alzheimer’s Disease

Retrieved on: 
Wednesday, April 5, 2023

ILAP was established in 2021 to reduce the time to market for innovative medicines in the United Kingdom.

Key Points: 
  • ILAP was established in 2021 to reduce the time to market for innovative medicines in the United Kingdom.
  • In addition, patients are also considered key partners and the patient voice is integrated at every development stage.
  • “We are delighted that MHRA has recognized the potential of AD04™ at same time we are launching our confirmatory trial,” said Jeffrey Madden, chief executive officer of ADvantage.
  • We hope this AD04 trial with ILAP designation will bring us one step closer,” he concluded.

ProFound AI Risk Outperforms Traditional, Widely-Accepted Breast Cancer Risk Models for Both Short-term and Long-term Risk Assessments

Retrieved on: 
Tuesday, April 4, 2023

ProFound AI Risk offered higher accuracy than Tyrer-Cuzick v8 for all women – regardless of menopausal status, breast density, and family history of breast cancer – with an area under the curve (AUC) ranging from 0.74-0.65 for ProFound AI Risk, compared to 0.62-0.60 for Tyrer-Cuzick v8.

Key Points: 
  • ProFound AI Risk offered higher accuracy than Tyrer-Cuzick v8 for all women – regardless of menopausal status, breast density, and family history of breast cancer – with an area under the curve (AUC) ranging from 0.74-0.65 for ProFound AI Risk, compared to 0.62-0.60 for Tyrer-Cuzick v8.
  • “This research shows that an image-based risk model can identify high-risk women who may benefit from additional screening or risk reducing intervention.
  • With ProFound AI Risk, clinicians can now do this with even greater accuracy,” said lead researcher, Mikael Eriksson, PhD, Karolinska Institutet.
  • “It is also worth noting that ProFound AI Risk offered higher accuracy than Tyrer-Cuzick for women with both dense and non-dense breasts.

ZimVie Announces Expanded Reimbursement and Exemplary Clinical Rating for Mobi-C®

Retrieved on: 
Monday, April 3, 2023

In addition, the clinical data for Mobi-C was awarded the highest quality rating of 10A* by the Orthopaedic Data Evaluation Panel in the United Kingdom.

Key Points: 
  • In addition, the clinical data for Mobi-C was awarded the highest quality rating of 10A* by the Orthopaedic Data Evaluation Panel in the United Kingdom.
  • “This reimbursement of the Mobi-C prosthesis is really excellent news.
  • ODEP provides the objective, systematic review and rating of the strength of evidence supporting the performance of medical devices.
  • “We applaud the French reimbursement decision for Mobi-C and welcome the exemplary 10A* rating from ODEP,” said Rebecca Whitney, Global President of ZimVie Spine.

CardieX advances to final phase of NIH's inaugural RADx Tech for Maternal Health Challenge

Retrieved on: 
Monday, April 3, 2023

IRVINE, Calif., April 3, 2023 /PRNewswire/ -- Global health technology company, CardieX Limited , is pleased to announce it has advanced to the final phase of the National Institutes of Health's (NIH) RADx Tech for Maternal Health Challenge , receiving a $75,000 cash prize.

Key Points: 
  • IRVINE, Calif., April 3, 2023 /PRNewswire/ -- Global health technology company, CardieX Limited , is pleased to announce it has advanced to the final phase of the National Institutes of Health's (NIH) RADx Tech for Maternal Health Challenge , receiving a $75,000 cash prize.
  • The NIH launched the Rapid Acceleration of Diagnostics (RADx®) Tech for Maternal Health Challenge as part of the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) initiative, which supports research to reduce preventable causes of maternal deaths and to improve health for women before, during, and after delivery.
  • CEO of CardieX, Craig Cooper said the company was delighted to have reached the next stage of the first RADx Tech for Maternal Health Challenge.
  • The ability to capture advanced arterial health insights will be a game changer for maternal health outcomes.