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Erleada® reduces prostate-specific antigen (PSA) by 86 percent
Erleada achieved an 86 percent reduction in PSA at 12 months in the majority of patients, shows post-hoc analysis of Phase III study.
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Melflufen increases refractory multiple myeloma survival in Phase III study
Melfufen met the primary endpoint of superior progression free survival (PFS) with a median of 6.8 months in Phase III OCEAN trial.
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Imfinzi™ and tremelimumab combo improves NSCLC outcomes
Imfinizi™ and tremelimumab in combination with chemotherapy improved non-small lung cancer (NSCLC) survival by 23 percent in a Phase III study.
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Lumakras™ (sotorasib) helps control brain metastases
Amgen’s Lumakras™, a KRAS inhibitor, was found to improve the stability of brain metastases in a Phase II study.
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Phase III trials for asthma treatment meet all primary endpoints
Avillion reported positive results from MANDALA and DENALI Phase III trials of PT027, an albuterol/budesonide combination, in asthma patients.
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EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
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HIV vaccine fails to protect women against infection
The investigational vaccine tested in sub-Saharan Africa posed no safety concerns but did not provide sufficient HIV protection.
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NICE approves inclisiran for LDL cholesterol reduction
The UK approval follows a Phase III study in which Leqvio® (inclisiran) reduced low-density lipoprotein cholesterol (LDL-C) by 55 percent.
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Increase in virtual trials improves patient accrual rates, finds report
The increased use of virtual components in clinical trials has led to fewer trial delays or terminations due to low participant numbers.
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Minjuvi® receives EC approval to treat large B-cell lymphoma
European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.
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FDA application to be submitted for Comirnaty® booster dose
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-300x278.jpg)
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-e1629795881701.jpg)
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Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
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Study shows no benefit of convalescent plasma for COVID-19 patients
An NIH trial found that COVID-19 convalescent plasma did not prevent disease progression in high-risk outpatients with early symptoms.
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FDA approves Jardiance® for heart failure with reduced ejection fraction
The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
