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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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Therapeutics
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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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NICE recommends tofacitinib for juvenile idiopathic arthritis
NICE has recommended Pfizer’s Xeljanz® (tofacitinib) as an option to treat polyarticular juvenile arthritis and juvenile psoriatic arthritis.
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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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Moderna and ILCM to develop Crigler-Najjar syndrome therapeutic
Moderna and the Institute for Life Changing Medicines (ILCM) are collaborating to develop an mRNA therapeutic for Crigler-Najjar syndrome.
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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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FDA reaches over 100 Competitive Generic Therapy approvals
The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.
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Single step antibody capture and clarification for intensified bioprocesses
Research shows magnetic beads coupled with protein A can clarify very high cell concentrations and capture antibodies with high efficiency in a single step.
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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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Six major disruptors for the generics and biosimilars market
In this article, EPR's Hannah Balfour outlines six factors that could significantly challenge the generics and biosimilars market in the next decade.
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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.
