Pfizer and BioNTech receive first U.S. FDA Emergency Use Authorization of a COVID-19 vaccine booster
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
Novartis acquires Arctos Medical, expanding optogenetics portfolio to bring gene therapies to patients with severe vision loss
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- Category: Novartis
Novartis announced that it has acquired Arctos Medical, adding a pre-clinical optogenetics-based AAV gene therapy program and Arctos’ proprietary technology to its ophthalmology portfolio. The acquisition underscores the Novartis commitment to finding treatments for patients with vision loss and the potential of optogenetics as the basis of successful therapeutics.
Pfizer and BioNTech announce positive topline results from pivotal trial of COVID-19 vaccine in children 5 to 11 years
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older.
University of Oxford and Oracle Cloud System helping researchers identify COVID-19 variants faster
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- Category: Business
The fast spread of the highly infectious Delta variant underscores the need for faster identification of COVID-19 mutations. Uniting governments and medical communities in this challenge, the University of Oxford and Oracle's Global Pathogen Analysis System (GPAS) is now being used by organizations on nearly every continent.
Roche opens access to pathology imaging tools to improve patient care
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the introduction of the Roche Digital Pathology Open Environment that allows software developers to easily integrate their image analysis tools for tumour tissue with Roche's uPath enterprise software, an application for pathologist workflow. This open environment allows for the secure exchange and flow of data so that pathologists can access advanced algorithms from third parties alongside Roche's menu of artificial intelligence-based image analysis tools.
Pfizer and BioNTech submit a variation to EMA with the data in support of a booster dose of COMIRNATY®
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- Category: Business
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.
Sandoz strengthens pipeline by entering into agreement for biosimilar bevacizumab, a key oncology medicine
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- Category: Novartis
Sandoz, a Novartis division, today announced that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706). Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments(1,2).
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