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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine
americanpharmaceuticalreview
May 08, 2021
Pfizer Inc. and BioNTech SE have announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
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Health Canada approves Pfizer and BioNTech’s Covid-19 vaccine for adolescents
pharmaceutical-technology
May 07, 2021
With Health Canada authorisation, the Pfizer and BioNTech vaccine became the first-of-its-kind indicated for this age group to receive approval in the country.
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Pfizer in talks with India over expedited approval for COVID-19 vaccine
expresspharma
May 07, 2021
Albert Bourla, CEO, Pfizer also announced a donation of medicines worth more than $70 million.
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UK buys another 60 million doses of Pfizer/BioNTech vaccine
pharmatimes
May 06, 2021
The UK government has secured an extra 60 million doses of Pfizer/BioNTech’s COVID-19 vaccine, in a bid to strengthen plans for the autumn COVID-19 vaccination programme.
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Pfizer, BioNTech seek CMA expansion for Covid-19 vaccine in EU
pharmaceutical-technology
May 06, 2021
Pfizer and BioNTech have submitted a request to the European Medicines Agency (EMA) to expand Conditional Marketing Authorization (CMA) of their Covid-19 vaccine, COMIRNATY (BNT162b2), in the European Union (EU) for use in adolescents aged 12 to 15 years.
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Vaxart’s Covid-19 vaccine shows cross-coronavirus activity in trial
pharmaceutical-technology
May 06, 2021
Vaxart has reported the latest data from the Phase I trial of its first Covid-19 oral vaccine construct, VXA-CoV2-1, which showed broad cross-reactivity against other coronaviruses.
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Pfizer 1Q Revenues up 45% Driven by COVID Vax
contractpharma
May 06, 2021
Vaccine sales were $4.9 billion in the quarter, with BNT162b2 contributing $3.5 billion in global revenues.
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US senators write to Pfizer, Moderna, J&J for global access to vaccines
expresspharma
April 30, 2021
According to the letter, there are several steps that vaccine companies could take to expand access to the vaccines globally, including in India.
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Pfizer Acquires Amplyx Pharmaceuticals
contractpharma
April 30, 2021
Pfizer has acquired Amplyx Pharmaceuticals, a privately-held company dedicated to the development of therapies for immune system disorders.
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Alphamab announced PD-L1/CTLA-4 bispecific antibody KN046 will enter new Phase II clinical trial in combination with Pfizer's Inlyta® (axitinib)
prnasia
April 29, 2021
Alphamab Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer to evaluate the efficacy and safety of KN046 in combination with Inlyta® (axitinib) for the first-line treatment of NSCLC.