Ministry of National Health Services, Regulation and Coordination

TB Alliance Announces Partnership with Remington Pharmaceuticals to Commercialize New Therapy for Drug-Resistant Forms of TB in Pakistan

Retrieved on: 
Monday, August 14, 2023
PVT, Partnership, TB Alliance, Public, TB, Linezolid, Miliary tuberculosis, Ministry of National Health Services, Regulation and Coordination, Medicine, Dauntless (video game), Government, Patient, Tuberculosis, Remington, WHO, Moxifloxacin, World Health Organization, Disease, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Non-profit drug developer TB Alliance has granted Remington Pharmaceutical Industries (Pvt.) Ltd. a non-royalty bearing license to market the anti-tuberculosis (TB) medicine pretomanid as part of the all-oral, six-month BPaL and BPaLM regimens for treatment of drug-resistant TB (comprised of bedaquiline, pretomanid, and linezolid, with or without moxifloxacin). Pakistan ranks third among countries designated by the World Health Organization as having a high burden of drug-resistant TB. Remington has agreed to develop, manufacture, and commercialize pretomanid in Pakistan and the collaboration may extend to other countries in the future.

Key Points: 
  • Pakistan ranks third among countries designated by the World Health Organization as having a high burden of drug-resistant TB.
  • Remington has agreed to develop, manufacture, and commercialize pretomanid in Pakistan and the collaboration may extend to other countries in the future.
  • "Remington is proud and thrilled to collaborate with TB Alliance to provide solutions that could change the lives of drug-resistant TB patients in Pakistan.
  • The partnership with Remington is part of TB Alliance's global commercialization strategy for pretomanid as part of the BPaL/BPaLM regimens.

TB Alliance Announces Partnership with Remington Pharmaceuticals to Commercialize New Therapy for Drug-Resistant Forms of TB in Pakistan

Retrieved on: 
Monday, August 14, 2023
PVT, Partnership, TB Alliance, Public, TB, Linezolid, Miliary tuberculosis, Ministry of National Health Services, Regulation and Coordination, Medicine, Dauntless (video game), Government, Patient, Tuberculosis, Remington, WHO, Moxifloxacin, World Health Organization, Disease, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Non-profit drug developer TB Alliance has granted Remington Pharmaceutical Industries (Pvt.) Ltd. a non-royalty bearing license to market the anti-tuberculosis (TB) medicine pretomanid as part of the all-oral, six-month BPaL and BPaLM regimens for treatment of drug-resistant TB (comprised of bedaquiline, pretomanid, and linezolid, with or without moxifloxacin). Pakistan ranks third among countries designated by the World Health Organization as having a high burden of drug-resistant TB. Remington has agreed to develop, manufacture, and commercialize pretomanid in Pakistan and the collaboration may extend to other countries in the future.

Key Points: 
  • Pakistan ranks third among countries designated by the World Health Organization as having a high burden of drug-resistant TB.
  • Remington has agreed to develop, manufacture, and commercialize pretomanid in Pakistan and the collaboration may extend to other countries in the future.
  • "Remington is proud and thrilled to collaborate with TB Alliance to provide solutions that could change the lives of drug-resistant TB patients in Pakistan.
  • The partnership with Remington is part of TB Alliance's global commercialization strategy for pretomanid as part of the BPaL/BPaLM regimens.

Mahana Therapeutics Achieves Key Quality Control Credentials

Retrieved on: 
Wednesday, April 26, 2023
Technology, Biotechnology, Online Privacy, Alternative Medicine, Health, Apps, Applications, Other Health, Other Technology, Telemedicine, Virtual Medicine, Medical Devices, Managed Care, General Health, Health Technology, Data Management, Data management, System and Organization Controls, Cognitive behavioral therapy, Ministry of National Health Services, Regulation and Coordination, Accreditation, Therapy, National Health Service, ISO, Risk management, Certified Public Accountant, American Institute of Certified Public Accountants, Android, Irritable bowel syndrome, Research, SOC, Confidentiality, IOS, Certification, Tablet, UKCA, SOC 2, Patient, IBS, Quality assurance, United Kingdom, Cyber Essentials, Digital, FDA, American Institute, Dental Service Organizations, Medical device, Pharmaceutical industry

Mahana Therapeutics , a leading developer of digital therapeutics designed to empower people with chronic conditions to lead fuller lives, today announced that it has completed Service Organization Control (SOC) 2 Type II audit for its world class digital therapeutic offering.

Key Points: 
  • Mahana Therapeutics , a leading developer of digital therapeutics designed to empower people with chronic conditions to lead fuller lives, today announced that it has completed Service Organization Control (SOC) 2 Type II audit for its world class digital therapeutic offering.
  • “Mahana Therapeutics is proud to complete these important certifications, underscoring our commitment to the highest possible data management and quality standards for our customers,” said Simon Levy, co-founder and CEO of Mahana Therapeutics.
  • SOC Type II certification demonstrates that Mahana has implemented the highest standards to provide assurance for customers around data privacy and security controls.
  • “I am proud of the entire Mahana team for undertaking these rigorous quality programs and achieving compliance with SOC 2 and with Cyber Essentials,” said Kendal Dinsmore, VP of Global Regulatory Affairs & Quality Assurance, at Mahana Therapeutics.

The Pharma Mini MBA Training Course: Featuring Business School Pharmaceutical Case Studies

Retrieved on: 
Friday, April 21, 2023
Pharma, Ministry of National Health Services, Regulation and Coordination, University, National Health Service, Predicted impact of Brexit, PwC, RQA, Policy, Medication, Health, Health Economics, Euromed, HTA, Hoechst AG, Research, Patient, Doctor of Philosophy, Pharmaceutical Price Regulation Scheme, Bachelor of Science, Economics, Oguz, Integrity, International Drug Policy Consortium, Master of Science, Clinical research, Richard Roberts (pharmaceutical executive), Cancer Drugs Fund, Pharmacy school, School, Consumer, Phoenix International Holdings, Health technology assessment, Fine chemical, Pharmaceutical industry, Pharmacy

BSc (Economics), MSc (Health Economics) Leela Barham is an independent health economist and policy expert working on a freelance basis.

Key Points: 
  • BSc (Economics), MSc (Health Economics) Leela Barham is an independent health economist and policy expert working on a freelance basis.
  • This follows 7 years at a specialist economic consulting firm working in a small dedicated health and pharmaceutical team.
  • She regularly writes on hot topics affecting the industry for Pharmaceutical Executive, Pharmaphorum and EyeforPharma and has also written for PharmaTimes, and Pharma Pricing and Reimbursement.
  • Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff.

The Pharma Mini MBA Training Course: Accelerated Management Programme for Pharmaceutical Industry Employees - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 19, 2023
Health, Pharmaceutical, Pharma, Ministry of National Health Services, Regulation and Coordination, University, National Health Service, Predicted impact of Brexit, PwC, RQA, Policy, Medication, Health Economics, Euromed, HTA, Hoechst AG, Research, Patient, Doctor of Philosophy, Pharmaceutical Price Regulation Scheme, Bachelor of Science, Economics, Oguz, Integrity, International Drug Policy Consortium, Master of Science, Clinical research, Richard Roberts (pharmaceutical executive), Cancer Drugs Fund, Pharmacy school, School, Consumer, Phoenix International Holdings, Health technology assessment, Fine chemical, Pharmaceutical industry, Pharmacy

BSc (Economics), MSc (Health Economics) Leela Barham is an independent health economist and policy expert working on a freelance basis.

Key Points: 
  • BSc (Economics), MSc (Health Economics) Leela Barham is an independent health economist and policy expert working on a freelance basis.
  • This follows 7 years at a specialist economic consulting firm working in a small dedicated health and pharmaceutical team.
  • She regularly writes on hot topics affecting the industry for Pharmaceutical Executive, Pharmaphorum and EyeforPharma and has also written for PharmaTimes, and Pharma Pricing and Reimbursement.
  • She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry.

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
Ministry of National Health Services, Regulation and Coordination, Adverum Biotechnologies, Doctor of Pharmacy, Anti-VEGF, National Health Service, AMD, OPTIC, Eye, LUNA, PRIME, EMA, Patient, United Kingdom, European Medicines Agency, United, National Institute for Health and Care Excellence, Medicines and Healthcare products Regulatory Agency, Innovation, NHS, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, Fast track (FDA), NICE, Food, Caregiver, MHRA, Pharmaceutical industry

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.

LiveWell's Governors Club Care Home Receives 4 Star Rating!

Retrieved on: 
Wednesday, March 29, 2023
Club Drive, Alzheimer's disease, Human services, Livewell, Governors Club, North Carolina, Division, Ministry of National Health Services, Regulation and Coordination, North Carolina Department of Health and Human Services, Dementia

"LiveWell has a passionate and dedicated team of care home and home care professionals working in Governors Club.

Key Points: 
  • "LiveWell has a passionate and dedicated team of care home and home care professionals working in Governors Club.
  • We are honored to serve the families in Governors Club, and we look forward to the continued relationship," stated LiveWell CEO Mike Brosie.
  • "We have been residents and active members of the Governors Club community for over 14 years," stated LiveWell client Dr. Stephen Prystowsky.
  • LiveWell was founded in 2010 and focuses on Alzheimer's, Dementia, and other memory care challenges through its residential care homes (located throughout the Triangle area) and home care business.

Pluralsight Announces the 2022 Best in Tech Award Winners

Retrieved on: 
Tuesday, October 11, 2022
Cloud, Data science, Engineering, Rabobank, Technology, Conference, Machine learning, Sibling, Organization, Intelligence, Workforce, Investment, Philosophy, Artificial intelligence, Wells Fargo, Knowledge, AWS, Technology College, Cloud computing, Ford Motor Credit Company, L&D, Learning, Industry, International Air Navigation Conference, Flow, CEO, SSP, Capgemini, Estonian Information Technology College, Success, BMO, National Health Service, Ministry of National Health Services, Regulation and Coordination, Techcombank, Solution, BP, Creative industries, Management, Tutoring, Online shopping, Tech, Pluralsight

SILICON SLOPES, Utah, Oct. 11, 2022 /PRNewswire/ -- Pluralsight , the technology workforce development company, today announced the winners of its 2022 Best in Tech Awards.

Key Points: 
  • SILICON SLOPES, Utah, Oct. 11, 2022 /PRNewswire/ -- Pluralsight , the technology workforce development company, today announced the winners of its 2022 Best in Tech Awards.
  • The awards are designed to honor and celebrate Pluralsight customers who are innovating across their organizations through technology workforce development.
  • Congratulations to each of the Best in Tech recipients who are dedicated to empowering their people, and as a result, are creating incredible outcomes for their customers."
  • With Pluralsight Skills, A Cloud Guru, and engagement with Pluralsight Professional Services, Wells Fargo is leveraging Pluralsight for the blended learning approach they want to offer all employees across their technology organization.

Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine

Retrieved on: 
Thursday, April 14, 2022
EMA, Vero, VLA, Ministry of National Health Services, Regulation and Coordination, NHRA, Marketing, COVID-19, Population, Conditional, Medication, Lyme disease, VLA2001, European Medicines Agency, CpG, Chikungunya, Infection, Vaccination, Bahraini, 2020 European Medicines Agency cyberattack, MHRA, Technology, Vaccine, Nasdaq, Company, United Kingdom, National Health Service, 1018, Health care, Euronext Paris, Safety, CMA, Severe acute respiratory syndrome coronavirus 2, Trust

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence.

Key Points: 
  • Thomas Lingelbach, Chief Executive Officer of Valneva, commented, We are extremely pleased with this new authorization and would like to thank the MHRA for their trust and confidence.
  • VLA2001 is the only inactivated whole virus COVID-19 vaccine approved in the UK and this authorization could pave the way for the availability of an alternative vaccine solution for the UK population.
  • We continue to receive messages every day from people who are looking for a more traditional vaccine approach.
  • This new marketing authorization comes in addition to the emergency use authorization which was granted by the Bahraini NHRA in March 20221.

Global Shingles Vaccine Market to 2028 - Size, Share & Trends Analysis Report - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 12, 2022
Infectious Diseases, Pharmaceutical, Health, Medical Devices, Awareness, Government, Adoption, Ministry of National Health Services, Regulation and Coordination, Clinical trial, GlaxoSmithKline, NHS, CDC, Coordinating Ministry for Political, Legal, and Security Affairs (Indonesia), Ageing, Incidence, CAGR, Patient, Vaccine, National Health Service, SWOT analysis, JCVI, USD, Shingles, Disease, Risk, Postherpetic neuralgia, Politics, Immunization, Vaccination

Increasing incidence of shingles and high awareness regarding shingles in developed countries are contributing to the market growth.

Key Points: 
  • Increasing incidence of shingles and high awareness regarding shingles in developed countries are contributing to the market growth.
  • The inclusion of shingles vaccines in national immunization programs of several countries is anticipated to propel the demand for vaccines.
  • For instance, the shingles vaccine is a part of the national immunization program in the U.K. since 2013.
  • Chapter 3 Shingles Vaccine Market Variables, Trends & Scope
    3.4.2 SWOT Analysis; By factor (Political & Legal, Economic and Technological)