Pharma giant Roche gets US go-ahead for Covid-19 antibody test

The guardian | May 03, 2020

Swiss drug maker Roche Holding AG says it has received emergency use approval from the US Food and Drug Administration (FDA) for an antibody test to help determine if people have ever been infected with the coronavirus. Governments, businesses and individuals are seeking such blood tests to help them learn more about who may have had the disease, who may have some immunity and to potentially craft strategies to end lockdowns that have battered global economies. Roche had previously pledged to make its antibody test available by early May and to boost production by June to “high double-digit millions” per month.

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RecunnectLtd takes the pleasure to invite professionals involved in pharmacovigilance, risk assessment and management, clinical research, data analysis and related fields for a two day conference on Pharmacovigilance to enable them to gain a vantage point in the contemporary pharma industry by ingraining themselves with updates on regulatory trends in inspections of signal detection, post authorisation safety studies, optimal use of social media in pharmacovigilance, data mining technology, outsourcing Pharmacovigilance and strategic pharmacovigilance pre and post product life cycle. For more information, please visit our website – www.recunnect.com. To get in touch with us, please email info@recunnect.com or call +44 (0) 2071129183. For registrations, Please use the discount voucher code to avail extra £50 off online registration. For group discounts and bookings, please email info@recunnect.com For full terms and conditions, please visit www.recunnect.com/terms-conditions

Spotlight

RecunnectLtd takes the pleasure to invite professionals involved in pharmacovigilance, risk assessment and management, clinical research, data analysis and related fields for a two day conference on Pharmacovigilance to enable them to gain a vantage point in the contemporary pharma industry by ingraining themselves with updates on regulatory trends in inspections of signal detection, post authorisation safety studies, optimal use of social media in pharmacovigilance, data mining technology, outsourcing Pharmacovigilance and strategic pharmacovigilance pre and post product life cycle. For more information, please visit our website – www.recunnect.com. To get in touch with us, please email info@recunnect.com or call +44 (0) 2071129183. For registrations, Please use the discount voucher code to avail extra £50 off online registration. For group discounts and bookings, please email info@recunnect.com For full terms and conditions, please visit www.recunnect.com/terms-conditions

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BUSINESS INSIGHTS

Fusion Pharmaceuticals and Niowave Announce Actinium-225 Collaboration and Supply Agreement

Fusion Pharmaceuticals Inc. | June 13, 2022

Fusion Pharmaceuticals Inc. a clinical-stage oncology company focused on developing next-generation radio pharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of medical radioisotopes from radium and uranium, today announced that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225. Under the agreement, Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave's capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion's needs. "As excitement for the tumor-killing potential of alpha-emitting radio pharmaceuticals increases, we intend to stay at the forefront of actinium development and supply to support our growing pipeline of targeted alpha therapies. We continue to prioritize manufacturing and access to actinium as a critical component of Fusion's platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we advance multiple actinium-based radio pharmaceuticals in the clinic." Fusion Chief Executive Officer John Valliant, Ph.D "The Niowave team has worked hard to scale up our actinium-225 production to the millicurie level and this has allowed us to start working with oncology community partners," said Niowave Chief Executive Officer/Senior Scientist Terry Grimm, Ph.D. "We have been watching Fusion's progress in the development of their pipeline of targeted alpha therapies and we are very excited to partner with them on this journey." Fusion is developing actinium-based TATs leveraging the potency and precision offered by alpha particles. Actinium-225 decay gives off four alpha emissions in relatively rapid succession, maximizing the damage to the DNA of tumor cells, with a 10-day half life that allows for central manufacturing and distribution of products to clinical sites in a ready-to-use form. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. About Niowave Niowave manufactures radioisotopes to cure cancer and save lives. Niowave builds and operates superconducting electron linear accelerators and is using that expertise to produce various radioisotopes for nuclear medicine. Niowave is a Cooperative Agreement partner with the National Nuclear Security Administration to develop a domestic supply of molybdenum-99 and currently produces yttrium-90 for use in cancer therapy. Niowave is licensed by the NRC to manufacture radioisotopes from uranium and radium and has partnerships with several universities and national laboratories focused on production and purification of radioisotopes for use in cancer therapy. By using radium targets and electron beams, Niowave is able to produce ultra pure and carrier-free actinium-225. Niowave's R&D facility is currently supplying actinium-225 samples to partners. Production-scale operations are ramping up at a second, FDA-compliant facility capable of meeting the growing actinium-225 market.

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RESEARCH

Parexel and Veeva Collaborate to Speed-Up Clinical Trials

Parexel, Veeva Systems | May 04, 2021

Parexel and Veeva Systems announced a strategic partnership today to accelerate clinical trials through technological and process innovation. The unique partnership blends the best of each company's expertise through thousands of tests worldwide – Parexel as a pioneering CRO and Veeva as the technological innovator powering trials – to boost study performance and bring innovative therapies to patients faster. Parexel is standardizing Veeva's suite of clinical operations software, including Veeva Vault eTMF, Vault CTMS, and Vault Study Startup, as part of the agreement to streamline operations. Parexel's clients will now have access to Veeva Vault CDMS for clinical data storage as a free product. The companies will work together to continually develop Veeva's cloud technology and Parexel's clinical trial delivery processes based on the insights from sponsors, sites, and patients. Parexel will provide early access to and give feedback on Veeva's clinical products, such as innovations to support sites and patients in decentralized clinical trials (DCT), risk-based quality management (RBQM), and community-based sites. "By implementing Veeva's clinical solutions, we can streamline trial procedures, increase performance, and make trial implementation and attendance simpler for promoters, locations, and patients," Parexel CEO Jamie Macdonald said. "Through this extended relationship with Veeva, we hope to have more value to customers and have a much greater effect on the lives of patients." "We're happy to work with Parexel to fuel customer success and accelerate clinical research innovation," said Peter Gassner, Veeva's founder, and CEO. "By working together, we will help our customers get new vaccines, diagnostics, devices, and therapies to patients in need" About Parexel Parexel encourages the development of new innovative drugs to improve patient health. It provides services to clients in the life sciences and biopharmaceutical industries all over the world to help them transform scientific discoveries into new treatments. The therapeutic, technological, and functional ability is underpinned by a strong conviction in what we do, from decentralized clinical trials to regulatory advisory services to exploiting real-world insights. An independent council for Informa Pharma Intelligence voted Parexel the "Best Contract Research Organization" in December 2020. About Veeva Systems Veeva is the world's leading provider of cloud software for the life sciences industry. Veeva represents over 975 clients, ranging from the world's leading pharmaceutical firms to new biotechs, and is dedicated to innovation, product excellence, and customer success. Veeva is committed to balancing the needs of all stakeholders, including customers, employees, shareholders, and the industries it serves, as a Public Benefit Corporation.

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PHARMA TECH

CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021. Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022. "Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care." About CareRx Corporation CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

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