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FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib
pharmaceutical-business-review
October 30, 2020
Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg) ...
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Arixa Pharma to be acquired by Pfizer’s Hospital Business
expresspharma
October 26, 2020
Pfizer to develop ARX-1796 which, if approved, has potential to be the first novel oral beta-lactamase inhibitor + antibiotic combination in more than 35 years.
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Pfizer to seek approval for Covid-19 vaccine candidate next month
pharmaceutical-technology
October 19, 2020
Pfizer has announced plans to submit an application to the US Food and Drug Administration (FDA) seeking approval for its Covid-19 vaccine candidate next month.
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CStone Announces Completion of $200 million Share Sale to Pfizer
prnasia
October 16, 2020
CStone Pharmaceuticals announced today the completion of the Share Subscription Agreement through which an affiliate of Pfizer Inc. subscribed for newly issued CStone shares at approximately US$200 million (equivalent to approximately HK$1.55 billion)...
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Pfizer and BioNTech enter Covid-19 vaccine deal with New Zealand
pharmaceutical-technology
October 14, 2020
Pfizer and BioNTech have entered an agreement with the New Zealand Government to supply 1.5 million doses of their potential Covid-19 vaccine.
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Pfizer’s Ibrance flunks early breast cancer trial
pharmatimes
October 14, 2020
Pfizer’s oral CDK4/6 inhibitor Ibrance has failed to meet the primary endpoint of improved invasive disease-free survival (iDFS) in early breast cancer, nixing its chances in the adjuvant setting.
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IBRANCE (palbociclib) fails trial for early breast cancer treatment
expresspharma
October 10, 2020
No unexpected safety signals were observed and it did not meet improved invasive disease-free survival in women with HR+, HER2- early breast cancer in the PENELOPE-B trial.
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Pfizer and BioNTech initiate rolling submission for Covid-19 vaccine
pharmaceutical-technology
October 10, 2020
Pfizer and BioNTech have initiated a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the vaccine candidate against Covid-19.
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Pfizer and CStone to collaborate for oncology therapies in China
expresspharma
October 09, 2020
CStone to receive up to $280 million in milestone payments for sugemalimab, and additional royalties.
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Pfizer get USFDA nod for XELJANZ (tofacitinib) to treat active polyarticular course juvenile idiopathic arthritis
expresspharma
October 09, 2020
Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight.