PharmaJet | January 05, 2022
PharmaJet®, the maker of innovative, needle-free injection technology, announced that its partner Zydus Cadila, is partnering with Enzychem Lifesciences to manufacture their COVID-19 plasmid DNA vaccine in Korea. The plan is to manufacture 80+ million doses of the ZyCoV-D vaccine, which was recently granted emergency use approval by India’s national regulatory agency for those aged 12 years and above. The vaccine will be manufactured in Korea and exported to several lower-middle income countries in Latin America and Asian New Southern Policy member countries. It is exclusively delivered by the PharmaJet Tropis® Needle-free Injection System.
Under the terms of this agreement, Zydus will transfer its manufacturing technology and provide technical assistance to Enzychem Lifesciences. The vaccine is administered intradermally using the PharmaJet needle-free system, which can be deployed more readily, especially in resource-poor populations where these are urgently needed.
“This manufacturing agreement will enable people in lower-middle income countries access to a safe, well-tolerated and efficacious vaccine, delivered by a proven delivery system. Our systems have been successfully used to deliver millions of doses for polio immunization initiatives in Pakistan, Somalia, The Gambia, and numerous other countries. We are prepared for this commercialization initiative and have scaled our operations to meet the demand driven by COVID-19 vaccinations as we continue to fulfill our company mission of improving peoples’ lives through our needle-free delivery technology.”
Chris Cappello, President and CEO of PharmaJet
PharmaJet’s mission is to improve people’s lives through needle-free technology. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections.
Headquartered in Seoul, South Korea, Enzychem Lifesciences is developing novel small molecule therapeutics to target fundamental pathways in inflammation, patients with significant unmet needs in oncology, inflammatory, and severe respiratory diseases. Enzychem lead candidate, EC-18, has successfully completed US FDA phase 2 clinical testing in cancer patients. In response to the Korean government pledge for a Vaccine Hub, Enzychem has formed a consortium with Hanmi Pharma and several domestic companies in Korea to manufacture vaccines against COVID 19. The company plans to leverage its expertise in lipid chemistry and manufacturing to establish itself as a regional producer of lipid-based formulations for improved delivery of nucleic acids and other biologicals and drugs.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs over 23,000 people worldwide, including 1,400 scientists engaged in R & D, and is dedicated to creating healthier communities globally.
Transaction Data Systems | November 25, 2020
Exchange Data Systems (TDS), the pioneer in drug store programming answers for the network drug store market, today reported the obtaining of KloudScript, a strength drug store care arrangement.
Right now 39% of network drug stores apportion a type of strength prescriptions, agreeing the National Community Pharmacy Association. Interest for strength meds has been consistently ascending to treat explicit sickness states and the constantly sick. With the maturing populace and the expansion in ongoing consideration, forte drug store is required to develop to $500 billion as strength meds arrive at half of outpatient drug spend by end of 2020.
“Combining KloudScript’s capabilities with our market-leading solutions will empower our pharmacists to expand into specialty medication offerings,” said Jude Dieterman, CEO of TDS. “This acquisition further cements TDS’s leadership position in the independent pharmacy market and demonstrates our commitment to delivering the most clinically focused solution suite for community pharmacy.”
The increase in specialty medications has caused a shift in distribution and dosage form from traditional injectable and infusible formulations to oral dosage. At the end of 2019, 60% of the new drugs awaiting FDA approval were specialty medications with a noteworthy number in oral dosage form. The growth of specialty drugs and the shift to oral medications has opened a path for patient-focused pharmacists to further distinguish themselves through coordinated care of chronic disease states.
“We are excited to bring Kloudscript into the TDS suite of solutions and services,” stated Rinku Patel, Pharm D, KloudScript CEO and Founder. “Together we look forward to bringing innovative service solutions to our pharmacy, pharma, payor and prescriber partners that solve the accessibility, affordability and adherence challenges of patient care.”
Commonwealth Informatics, a Genpact company | January 25, 2022
Commonwealth Informatics, an independently-operated subsidiary of Genpact, and leading technology and services company with industry expertise in medical product safety and public health surveillance, today announced that it has expanded its relationship with the Medicines and Healthcare products Regulatory Agency, a medical regulatory body for the United Kingdom.
MHRA has selected Commonwealth Informatics' state-of-the-art signal detection and signal management solution, Commonwealth Vigilance Workbench (CVW), to support the MHRA transformation of safety monitoring through a single integrated platform across all medicines, vaccines, blood components and devices.
"The MHRA is looking to transform our vigilance services through new ways of working, underpinned by the technology we use and how we operate our services. We see our partnership with CVW enabling us to deliver a more responsive safety surveillance system through innovative technology."
Mick Foy, Head of Pharmacovigilance Strategy at MHRA
"We are delighted to have the opportunity to build on our longstanding research collaboration with the MHRA and deliver future value through greater efficiencies within signal detection," said Bill Blackwell, Commonwealth VP Safety Science Solutions. "The collaborative partnership will enable us, together with the MHRA, to bring new innovative methodologies to safety surveillance on behalf of patients."
Commonwealth's solution will be implemented to perform signal detection and signal management across multiple data sources leveraging advanced automation, such as artificial intelligence, to ensure more accurate multivigilance analysis and processing. CVW is an integrated cloud-based signal management system supporting the detection, tracking and refinement of safety signals using evidence across multiple data sources.
The MHRA is deploying Insife's HALOPV solution for case processing management, advanced automation, and real-time reporting and analytics. Commonwealth Informatics has partnered with Insife, to integrate CVW with HALOPV and to collaboratively deploy the end-to-end multi-vigilance platform in Q2 2022. Insife, headquartered in Denmark, offers specialist consulting services in multivigilance (Medicines and Devices), Regulatory Affairs (RA), and Information Technology (IT) implementation. Insife's services are based on expertise across the life sciences value chain with an understanding of digital transformation and drug safety assurance through process optimisation and automation.
About Commonwealth Informatics
Commonwealth Informatics is a technology and services company with industry expertise in medical product safety and public health surveillance. Pharmaceutical and biotechnology companies, government agencies, and healthcare providers use Commonwealth's products and services to assemble relevant data and answer complex clinical and safety analysis questions quickly and accurately. Commonwealth is an independently-operated subsidiary of Genpact, a global professional services firm focused on delivering digital transformation.
About Medicines and Healthcare products Regulatory Agency
MHRA, based in London, is an executive agency sponsored by the Department of Health and Social Care, that regulates medicines, medical devices and blood components for transfusion in the United Kingdom. Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.