Health Products Regulatory Authority

Charles River and Vertex Pharmaceuticals Reach Important Milestone in Cell Therapy Manufacturing Collaboration

Retrieved on: 
Montag, Dezember 18, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Medical Devices, Genetics, Life expectancy, NYSE, DNA, GMP, Food, European Medicines Agency, CRISPR Therapeutics, Therapy, CDMO, Vertex, EMA, Patient, FDA, Blood, Health Products Regulatory Authority, Cas9, CRL, CRISPR, Oxygen, SCD, HPRA, News, Pharmaceutical industry, Vaccine

Charles River Laboratories International, Inc. (NYSE: CRL) today announced an important milestone in their strategic collaboration to manufacture CASGEVY™ (exagamglogene autotemcel [exa-cel]).

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) today announced an important milestone in their strategic collaboration to manufacture CASGEVY™ (exagamglogene autotemcel [exa-cel]).
  • “We are pleased to reach this milestone working hand-in-hand with Vertex to manufacture the world’s first gene-edited therapy.
  • Charles River provides cell and gene-modified cell therapy developers with an efficient, robust, and scalable process to swiftly transition autologous and allogeneic programs to clinic and commercialization with one production partner.
  • Combined with the Company’s legacy testing capabilities, Charles River offers an industry-leading “concept-to-cure” advanced therapies solution.

Audere Launches HealthPulse TestNow™ Digital Companion App for Self-Testers

Retrieved on: 
Mittwoch, April 5, 2023
Software, General Health, Philanthropy, Apps, Applications, Technology, Infectious Diseases, Artificial Intelligence, Health Technology, Foundation, COVID-19, Other Technology, Other Philanthropy, Health, SAHPRA, Built-in self-test, Health equity, Diagnosis, Partnership, RDT, Health Products Regulatory Authority, Collection, Digital, COVID-19 testing, Pharmaceutical industry

Audere , a digital health nonprofit developing solutions to advance health equity, today announced HealthPulse TestNow™ , the first COVID-19 app deployed in South Africa that supports self-testers with the administration and interpretation of rapid diagnostic tests (RDT).

Key Points: 
  • Audere , a digital health nonprofit developing solutions to advance health equity, today announced HealthPulse TestNow™ , the first COVID-19 app deployed in South Africa that supports self-testers with the administration and interpretation of rapid diagnostic tests (RDT).
  • HealthPulse TestNow™ helps ensure the accurate use of RDTs through easy-to-follow instructions, process control timers, and guided result interpretation.
  • “We are proud to announce the first deployment of HealthPulse TestNow™ in South Africa.
  • Medical Diagnostech’s COV ID-19 Antigen Self T est 1, the first COVID-19 self-test manufactured in Africa to receive South African Health Products Regulatory Authority (SAHPRA) approval in 2023, will be the first test covered by Audere’s HealthPulse TestNow™ digital companion app.

Audere and South Africa-Based Medical Diagnostech Partner to Bring Africa’s First Home-Grown COVID-19 Antigen Test to Market with Digital Companion App

Retrieved on: 
Freitag, März 11, 2022
Research, Technology, Infectious Diseases, Software, Philanthropy, Biotechnology, General Health, Health, Foundation, Science, South African Medical Research Council, ISO, HIV, Disease management, Health Products Regulatory Authority, Pregnancy, Department, Partnership, Research, Public health, Machine learning, Google Play, Accreditation, App Store (iOS/iPadOS), Membrane protein, Investment, Technology Innovation Agency, Bill, SAMRC, Department of Science and Innovation, MD, Artificial intelligence, Capsid, Health equity, SAHPRA, Solution, COVID-19, Innovation, Global health, Bill & Melinda Gates Foundation, Immunity, Severe acute respiratory syndrome coronavirus 2, Infection, Malaria, Medical device, Mobile phone, Pharmaceutical industry, Audere, Medical Diagnostech, AUDERE, MEDICAL DIAGNOSTECH

Access to aggregated test data will provide a comprehensive understanding of disease prevalence, enabling more informed surveillance and disease management.

Key Points: 
  • Access to aggregated test data will provide a comprehensive understanding of disease prevalence, enabling more informed surveillance and disease management.
  • As a South African, I have first-hand experience with the test inequity challenges faced by individuals in my country.
  • I feel extreme pride to partner with Medical Diagnostech and support the roll-out of a COVID-19 rapid test made on the continent, for the continent.
  • The increased public health reporting capabilities enabled by digitizing rapid diagnostic test result data are crucial to South Africas evolving public health strategy.