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Global pharmacovigilance market to value almost $15bn by 2028
Research suggests outsourcing and the increasing incidence of adverse drug reactions (ADR) will be primary drivers of growth in the global pharmacovigilance market.
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Drug Safety
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Novel vaccine 77 percent effective in preventing malaria, finds study
The R21 vaccine candidate, when administered with 50mg of adjuvant, was found to be 77 percent effective in preventing malaria in children over 12 months.
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EMA and ECDC to collaborate on post-marketing monitoring of COVID-19 vaccines
Under a new initiative, the EMA will monitor on the safety of marketed COVID-19 vaccines while the ECDC monitors their effectiveness in Europe.
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Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-300x278.jpg)
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-e1619436264802.jpg)
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Janssen COVID-19 Vaccine approved for continued use in US
The US FDA and CDC have confirmed that the single-shot COVID-19 vaccine’s benefits continue to outweigh the risks of clotting and have given approval for its use to resume.
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Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
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NICE recommends ravulizumab for treatment of a rare blood disorder
On the NICE’s recommendation, ravulizumab will be made available to hundreds of patients with paroxysmal nocturnal haemoglobinuria on the UK’s NHS.
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FDA approves Jemperli for advanced endometrial cancer
Jemperli (dostarlimab) was granted accelerated approval after 42.3 percent recurrent or advanced endometrial cancer patients with deficient mismatch repair responded in a trial.
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Is the compendia-recommended microorganism test panel truly representative?
A recently published paper suggests the test panel of microorganisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.
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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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First patients dosed with Fasenra in three dermatology trials
With the addition of the new dermatology trials, Fasenra is now being evaluated in nine different indications associated with eosinophilic immune dysfunction.
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Measurement of heavy metals in cannabis vaping aerosols: a practical assessment
In light of the increased popularity of cannabis vaping in the United States, new regulations in the state of Colorado assert the need to test for heavy metal contaminants. Here, Robert Thomas explains the reasons for this pressing need and the challenges it presents.
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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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Stem cell transplantation may be able to prevent major cause of death in preterm infants
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.
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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.
