BioNTech, a German biotechnology company, has joined forces with US pharma giant Pfizer to develop mRNA-based flu vaccines as part of a $425 million multi-year research and development (R&D) collaboration. As per the terms of the deal, BioNTech and Pfizer will jointly take up research and development activities for advancing mRNA-based vaccines to prevent influenza […]
Continue reading …Nivestym FDA approval : Pfizer’s Amgen neutropenia drug Neupogen biosimilar gets FDA nod
July 21, 2018 No Comment
Nivestym FDA approval : Pfizer has bagged approval from the US Food and Drug Administration (FDA) for Nivestym (filgrastim-aafi) – a biosimilar to Neupogen (filgrastim) for all eligible indications of the reference Amgen neutropenia drug. Filgrastim is indicated in the US for neutropenia treatment among others. Neutropenia or low blood neutrophils, is a condition in […]
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Xtandi FDA approval : Astellas Pharma and Pfizer said that the US Food and Drug Administration (FDA) has expanded the approval of cancer drug Xtandi (enzalutamide) to be used for treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). The earlier Xtandi FDA approval, which came in 2014, was for the treatment of men with […]
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The US Food and Drug Administration (FDA) has given the green signal to Servier and Pfizer to carry out the clinical development of their UCART19 lymphoblastic leukemia drug for relapsed/refractory acute lymphoblastic leukemia treatment. In this regard, the FDA granted the pharmas with the Investigational New Drug (IND) clearance for the allogeneic, gene-edited cellular therapy […]
Continue reading …Pfizer’s blood cancer drug inotuzumab ozogamicin gets FDA priority review
February 23, 2017 No Comment
Pfizer’s blood cancer drug, inotuzumab ozogamicin has secured a priority review designation from the US Food and Drug Administration (FDA). Inotuzumab ozogamicin has been developed as an anti-CD22 antibody-drug conjugate to treat patients suffering from acute lymphoblastic leukemia (ALL) whether the disease has recurred or in refractory form. As of now, the blood cancer drug […]
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