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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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Covid-19
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Technologies and tactics for accelerating end-to-end biologic drug development
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
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AZD7442 reduces COVID-19 risks by 83 percent in Phase III trial
A separate treatment trial showed 88 percent reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
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EMA issues advice on use of Lagevrio for the treatment of COVID-19
The Europe Medicines Agency (EMA)'s human medicine committee advise (CHMP) that Lagevrio can be used for COVID-19 patients who do not require oxygen and are at increased risk.
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Europe to donate 70 million doses of Moderna’s COVID-19 vaccine
18 November 2021 | By
The agreement enables the EU and European Economic Area (EEA) countries to donate Moderna's COVID-19 vaccine to low-income countries.
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Pfizer and MPP to expand COVID-19 oral antiviral treatment access
The license agreement between Pfizer and the Medicines Patent Pool (MPP) will enable access to Pfizer's antiviral candidate in 95 countries.
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
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Anti-viral COVID-19 nasal spray to be commercialised
Birmingham Biotech and the University of Birmingham, UK, have signed a licensing agreement for an anti-viral nasal spray against COVID-19.
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Oral antiviral candidate Paxlovid™ reduces COVID-19 risks by 89 percent
Paxlovid™, Pfizer's investigational oral antiviral candidate, displayed an 89 percent reduction in COVID-19 risks in Phase II/III study.
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FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
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CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
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D&I: What health companies should be doing post-pandemic
Luke Robinson from Included highlights the impact of diversity and inclusion issues in the pharma industry, reflecting on the benefits to be gained from fundamental engagement with them.
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Co-creating solutions that advance global health innovation – IFPMA’s role
The COVID-19 pandemic has altered and continues to shape our lives. Here, Thomas B Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), gives insight into how the pandemic gave impetus to the organisation’s manifesto to innovate and save lives.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
