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The adoption of the 2014 Clinical Trial Regulation moves one step closer as the EMA confirms a key aspect, the EU trials database and portal, is on track for implementation.
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
Transplanting stem cells directly into the trachea of preterm infants with bronchopulmonary dysplasia was found to be safe and of some benefit in the most vulnerable group.
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.
New Phase III data shows once daily treatment with baricitinib significantly increases hair regrowth in adult patients with severe alopecia areata.
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
The lowest dose of the gene therapy was shown to be safe and somewhat improved vision in the first three patients treated in the trial.
![A bottle of Advil over the counter pain medication [Credit: Rajarajan Kannanb/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Advil-bottle-300x278.jpg)
![A bottle of Advil over the counter pain medication [Credit: Rajarajan Kannanb/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Advil-bottle-e1618917106973.jpg)
GSK Consumer Healthcare aims to reduce the plastic in all Advil bottles sold online and in store by 20 percent by 2022.
Enhertu® (trastuzumab deruxtecan) has been made available to allow for more safety and efficacy data to be collected prior to the NICE’s decision about its routine use on the NHS.
The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
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.
The new chapter, to be released in May, highlights the benefits of water activity measurement, as well as potential applications and best practices for use in pharmaceutical manufacturing.
Using a new precipitation method eliminates the need for the costly chromatography process and could make antibody therapies more affordable to produce, according to Andrew Zydney.
The ChAd63-KH vaccine, used to treat leishmaniasis rather than prevent in this trial, significantly improved symptoms in patients with persistent post-kala-azar dermal leishmaniasis.
Initial results suggest NT-300 (nitazoxanide extended-release tablets, 300mg) reduces progression to severe illness in mild to moderate COVID-19 patients.
