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Neoadjuvant atezolizumab combination meets safety criteria in pleural mesothelioma
Neoadjuvant cisplatin and pemetrexed in combination with atezolizumab met safety criteria in resectable pleural mesothelioma clinical study.
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Clinical Trials
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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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Embedding inclusion in pharmaceutical design
In this article, Included’s Raafi-Karim Alidina explores biases in product design, outlining how they impact pharmaceuticals as well as technologies, and practical steps to enhance diversity and ensure inclusion.
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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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NICE recommends bimekizumab for severe plaque psoriasis treatment
Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
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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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EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
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Phase III clinical trial for respiratory syncytial virus (RSV) vaccine begins
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
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FDA approves Invega Hayfera™ for the treatment of schizophrenia
Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.
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Fostamatinib reduces COVID-19 risks by 50 percent in Phase II study
Fostamatinib significantly reduced serious adverse effects and risk of death in hospitalised COVID-19 patients, shows Phase II study.
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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.
