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Inactivated COVID-19 vaccine candidate enters comparative immunogenicity trial
The Phase III trial aims to demonstrate that Valneva’s VLA2001 is more immunogenic than AstraZeneca's conditionally approved COVID-19 vaccine, Vaxzevria.
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FDA halts COVID-19 vaccine production at Emergent facility
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
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Plasma-derived therapies require a mastery of advanced bioproduction techniques
Plasma-derived therapies and medicines provide life-changing treatments for patients around the world who suffer from serious, and often rare, diseases that affect the immune system or result from non-functioning proteins in blood plasma. Carole Resman, Executive Vice President Production at LFB, describes the complex and highly regulated manufacturing process of…
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FDA revokes bamlanivimab Emergency Use Authorization
The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
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INO-4800 COVID-19 vaccine provides cross-reactive immune responses against variants
Antibodies induced by the investigational DNA vaccine candidate, INO-4800, were found to be able to neutralise three SARS-CoV-2 emerging variants of concern.
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NT-300 tablets show promise in Phase III COVID-19 trial
Initial results suggest NT-300 (nitazoxanide extended-release tablets, 300mg) reduces progression to severe illness in mild to moderate COVID-19 patients.
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European Pharmaceutical Review Issue 2 2021
European Pharmaceutical Review's latest journal features articles discussing the challenges and potential of antibody-drug conjugates, innovations in cleanroom infrastructure and why we need to test for heavy metal contaminants in cannabis vaping aerosols. Also in the issue, an exploration of how risk-sharing strategies could help expedite access to COVID-19 vaccines,…
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Novavax’ COVID-19 vaccine to be included in UK’s mixed regimen study
Novavax has agreed to participate in the University of Oxford’s Com-COV2 study evaluating the safety and efficacy of regimens consisting of doses of COVID-19 vaccines from different manufacturers.
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Clinical trial packaging – what can we expect from the market?
EPR discusses the findings of market research reports, unveiling how, where and why the global clinical trial packaging market will grow between now and 2027.
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NIAID doses first patient with Moderna’s variant specific COVID-19 vaccine candidate
The trial will evaluate the safety and immunogenicity of the mRNA-1273.351 vaccine candidate in 200 healthy adult volunteers.
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Celonic to produce 100 million doses of CureVac’s COVID-19 vaccine candidate
Production of CureVac’s CVnCoV vaccine will take place in Germany, with over 50 million doses expected to be produced in 2021.
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First ever Award for Extraordinary Impact on Health bestowed on Moderna and Pfizer
While announcing 2021’s Top 10 Clinical Research Achievement Awards, the US Clinical Research Forum revealed that Pfizer and Moderna would be honoured for their COVID-19 vaccines.
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Lenzilumab™ significantly improves survival in hospitalised COVID-19 patients
In a Phase III trial, adding Lenzilumab™ to steroid and remdesivir regimens improved the likelihood of survival without need for mechanical ventilation by 54 percent.
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African Union to receive 220 million doses of Janssen COVID-19 Vaccine
The African Vaccine Acquisition Trust (AVAT) has entered into an advanced purchase agreement for 220 million doses of Janssen COVID-19 Vaccine.
