Spotlight

In a breakthrough approach that combines virtual reality and artificial tactile sensations, two amputees feel as though their prosthetic hand belongs to their own body. Moreover, the scientists show that the phantom limb actually grows into their prosthetic hand.

Spotlight

In a breakthrough approach that combines virtual reality and artificial tactile sensations, two amputees feel as though their prosthetic hand belongs to their own body. Moreover, the scientists show that the phantom limb actually grows into their prosthetic hand.

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PHARMA TECH

TransPerfect Life Sciences Introduces Trial Interactive CTMS Solution

Trial Interactive | November 12, 2021

TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of the Trial Interactive (TI) Clinical Trial Management System (CTMS). This release marks the industry's only mobile-first CTMS, placing important actions and information at the fingertips of study managers and CRAs and supporting a full author-to-archive process. Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) effectively streamline product development life cycles. The platform improves speed, quality, and compliance across site identification, site feasibility, study start-up, site personnel training, regulated content management, eISF, and eTMF management. The addition of TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment. Designed by clinical professionals for clinical professionals, TI CTMS benefits include World-Class User Experience – The time-saving and pain-free mobile-first interface, with full-text and segmented metadata search, flexible filtering and exports, dark mode, and one-click navigation, creates the industry's friendliest user experience. By Clinical, for Clinical – Enjoy greater efficiency without the hassle, and get started quickly with no heavy configuration required and best practices built into the default configuration. True SaaS Solution – TI CTMS is a single-study or enterprise SaaS solution developed by experts. TransPerfect's award-winning service teams support rapid implementation plans with full validation. Enterprise Ready – With the flexibility to align with large-scale operations, TI CTMS enables enterprises with complex study teams to easily update the system to meet unique requirements and have access to a comprehensive web services API supporting third-party integrations. Author-to-Archive Platform – Streamline processes and oversight with content management solutions supporting the workflow of documents across the life cycle from site and study personnel to the eTMF in one seamless process. As clinical operations become more decentralized, TI CTMS continues Trial Interactive's mission of providing practical innovation to improve the efficiency of global clinical processes while reducing costs. "Having consulted with many organizations and colleagues over the years about CTMS, we've recognized common challenges like time-consuming configurations, difficult navigation, and user experiences that are clearly developed without the input of clinical operations experts. The end result is that existing platforms have fallen short of the features that study managers and CRAs really needTI CTMS was built by clinical professionals for clinical professionals and cuts configuration times while delivering powerful capabilities in a clean user experience that perfectly addresses the needs of sponsors and CROs." Michael Smyth, Division President of TransPerfect Life Sciences TransPerfect President and CEO Phil Shawe stated, "The launch of TI CTMS comes at a time when conducting remote and decentralized clinical trials is more important than ever. The CTMS is connected to our eTMF and other platform solutions to deliver a mobile-first experience that ensures study teams can work effectively and at scale from any location." About Trial Interactive TransPerfect's Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. About TransPerfect Life Sciences TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. About TransPerfect TransPerfect is the world's largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

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PHARMACY MARKET

EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)

CureVac, EMA | February 18, 2021

The European Medicines Agency (EMA's) Committee for Human Medicinal Products (CHMP) has begun a moving audit of CureVac AG's COVID-19 antibodies, CVnCoV. The survey was started on the grounds that starter research facility contemplates and early clinical preliminary outcomes recommend the immunization triggers the creation of antibodies and insusceptible cells that target SARS-CoV-2, the infection that causes COVID‑19. The survey will successively audit information as it opens up, beginning with the preclinical and beginning stage proof presently submitted. As opposed to a customary advertising authorisation application, in which all information on a medication's or immunization's viability, security and quality and all necessary archives should be prepared toward the beginning of the assessment. Continuous preliminaries are proceeding to assess the immunization's wellbeing, immunogenicity and viability against COVID-19. EMA will assess information from these and other clinical preliminaries as they become accessible. The moving audit will proceed until the CHMP concludes that adequate information is accessible for a conventional showcasing authorisation application. Because of the work attempted in the moving audit, it should take less time than typical to assess such an application. EMA will survey the immunization's consistence with the typical norms for adequacy, wellbeing and drug quality inside the moving audit measure. About CVnCoV CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly. When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.

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PHARMA TECH

PharmaJet partner Zydus Cadila Announces COVID-19 Vaccine Expansion Plan to Multiple Countries With Korean Firm

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 About 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. About Enzychem 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. About Zydus 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.

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