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© 2020 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2020 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
October 22, 2020
The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.
The companies will work to accelerate the clinical development and manufacturing of the treatment, while determining its safety and efficacy.
October 19, 2020
The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.
October 13, 2020
The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.
Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic.
The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.
October 12, 2020
The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.
October 09, 2020
Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.
Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.
October 07, 2020
Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
October 06, 2020
Experts fear confusion over allocation process, cold-chain requirements, IT systems.
The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.
October 05, 2020
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.
October 02, 2020
Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
Misleading messages contribute to eroding trust in public health agencies.
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
October 01, 2020
The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.
The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.
September 28, 2020
Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.