Pfizer and BioNTech submit application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.
Bayer supports demining in Ukraine with donation to non-profit "Fondation suisse de déminage"
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- Category: Bayer
Bayer supports the humanitarian non-profit organization "Fondation suisse de déminage" (FSD) in their mission to demine land that was contaminated by mines and unexploded devices since the onset of the war in Ukraine. A donation of 825,000 euros will be dedicated to purchasing a large-size mechanical mine clearance machine.
Pfizer announces positive top-line results from Phase 3 study of 20-valent pneumococcal conjugate vaccine in infants
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) announced positive top-line results from its pivotal U.S. Phase 3 study (NCT04382326) in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.
Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.
Pfizer to acquire Global Blood Therapeutics for $5.4 billion to enhance presence in rare hematology
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced the companies have entered into a definitive agreement under which Pfizer will acquire GBT, a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities, starting with sickle cell disease (SCD).
Roche's subcutaneous formulation of Tecentriq demonstrates positive Phase III results
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq® (atezolizumab) met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed.
Bayer Consumer Health leaders propose new principles for science-led self-care
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- Category: Bayer
Bayer has published a new paper, Science-Led Self-Care: Principles for Best Practice, that sets out five key Principles that should underpin all self-care products improving personal health and wellness. The paper is intended to spark a conversation within the industry and its key stakeholders around the need to promote science-led self-care for the benefit of consumers.
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- Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
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- Sanofi Global Health launches nonprofit Impact® brand for 30 medicines in low-income countries