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.
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.
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.
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.
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.
EMA board confirms the EU clinical trial portal and database is fit for purpose
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.
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.
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.
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.
Baricitinib enhances hair regrowth for alopecia areata patients
New Phase III data shows once daily treatment with baricitinib significantly increases hair regrowth in adult patients with severe alopecia areata.
Pharmaceutical sterility testing market to value over $1000 million by 2027
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.
Novel blindness gene therapy shows promise in first-in-human trial
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.
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Advil to reduce plastic waste through implementing new sustainable plastic technology
GSK Consumer Healthcare aims to reduce the plastic in all Advil bottles sold online and in store by 20 percent by 2022.
Enhertu® made available to breast cancer patients on UK’s Cancer Drugs Fund
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.
