A compilation of recent notable news developments that pertain to the clinical trials industry.
Johnson & Johnson and its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the U.S. following approval or emergency use authorization byFDA.
The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, in collaboration with the U.S. Department of Defense, is committing over $1 billion for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.
J&J efforts to develop a SARS-CoV-2 vaccine have been undertaken pursuant to an ongoing R&D collaboration with BARDA and under the oversight of FDA. Based on the positive preclinical data recently published in Nature, the Phase I/IIa first-in-human clinical trial of Ad26.COV2.S is underway in healthy volunteers in the U.S. and Belgium.
Sanofi and GlaxoSmithKline have reached an agreement, subject to final contract, with the U.K. government for the supply of up to 60 million doses of a COVID-19 vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s pandemic adjuvant technology.
Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase I/II study to start in September, followed by a Phase III study by the end of 2020. If the data are positive, regulatory approval could be achieved by the first half of 2021.
Covance, the CRO unit of LabCorp, has acquired GlobalCare, a provider of patient-centric decentralized clinical trials support services. This acquisition will expand Covance’s decentralized study capabilities globally, enabling recruitment and increasing access to trials. Specifically, Covance will leverage GlobalCare’s mobile healthcare services, site staffing support, patient transport assistance, and contracted central pharmacy services.
GlobalCare will also complement its existing services with additional decentralized trial services via Covance’s capabilities, such as eConsent, telehealth, electronic data capture (EDC), online patient scheduling, connected device solutions, and more.
IQVIA is collaborating with AstraZeneca to accelerate development of AZ’s potential new vaccine for COVID-19. This joint initiative is part of the U.S. government’s recently announced Operation Warp Speed project. The initiative includes an expansive subject study, which is expected to begin enrolling this summer and will leverage IQVIA’s virtual trial solutions, including Study Hub.
Myoderm, a clinical trial supply company, broke ground on its new global headquarters and U.S. operational facility on a 14-acre site in Horsham, Pa. The 65,000-square-foot facility will include 20,000-sq.-ft. of office space and a 45,000-sq.-ft. warehouse and distribution center with staging, shipping, and receiving areas; rack storage in ambient temperatures and 2–8-degree Celsius cold box; -20-degree C and -80-degree C freezer storage; and secondary labeling rooms, all designed to current good manufacturing practices guidelines.
Novo Nordisk recently entered into a definitive agreement to acquire Corvidia Therapeutics Inc., a privately held, clinical-stage company focused on the R&D of transformative therapies for cardio-renal diseases. Corvidia’s lead candidate, a fully human monoclonal antibody directed against Interleukin-6, is being developed to reduce the risk of major adverse cardiovascular events in chronic kidney disease patients with atherosclerotic cardiovascular disease and inflammation.
The transaction will not impact Novo Nordisk’s previously communicated operating profit outlook for 2020.
— Staff and wire reports
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