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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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Biologics
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Janssen COVID-19 Vaccine – one regulator blocks use, another promotes it
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
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Comirnaty® COVID-19 vaccine protects against multiple viral variants
Laboratory study shows the blood sera of people vaccinated against COVID-19 with Comirnaty® can neutralise at least six viral variants including three variants of concern.
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COVID-19 antibody therapies safe and effective for transplant patients
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
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Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
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Janssen COVID-19 Vaccine can protect against variants of concern
Trial shows the single-shot Janssen COVID-19 Vaccine generates robust immune responses against several COVID-19 variants.
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Cancer vaccine shows promise in glioblastoma trial
Personalised cancer vaccine increases progression free survival by approximately 50 percent in patients with newly diagnosed glioblastoma.
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Sanaria® PfSPZ-CVac vaccine 75 percent effective at preventing malaria
Clinical studies optimising immunisation with Sanaria’s PfSPZ-CVac vaccine resulted in 77 and 75 percent of participants being protected from malaria infection.
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On-demand webinar: Contamination control strategy essentials
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
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Navigating the transition from IVDD to IVDR
9 June 2021 | By Tecan
This on-demand webinar brings three leaders in the field together to discuss the new regulations, responsibilities across the whole supply chain, documentation, the notified body application process and key timelines.
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EMA to assess whether COVID-19 Vaccine Moderna can be used in adolescents
The European Medicines Agency (EMA) has begun evaluating whether to extend the use of the COVID-19 Vaccine Moderna to include adolescents aged 12 to 17.
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Experts call for improved oversight to combat rise of unproven stem cell therapies
Stem cell therapy authorities urge the WHO to create an advisory committee for regenerative medicine and work to combat the rising use of unproven stem cell therapies worldwide.
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Infographic: How different endotoxin testing platforms work
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
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Alzheimer’s drug Aduhelm™ authorised in US under accelerated approval
Aduhelm™ (aducanumab-avwa) is the first new treatment approved for Alzheimer’s since 2003 and the first therapy to target the fundamental pathophysiology of the disease – amyloid plaques.
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Imfinzi increases five year survival to 43 percent in Stage III lung cancer trial
New data shows AstraZeneca’s Imfinzi (durvalumab) achieved an unprecedented five year survival rate of over 40 percent in patients with Stage III non-small cell lung cancer.
