Pfizer and BioNTech receive CHMP positive opinion for COVID-19 vaccine booster in the European Union
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- Category: Business
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.
Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load in patients hospitalised with COVID-19
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own (seronegative) and who required low-flow or no supplemental oxygen (p=0.0172).
Sanofi to focus its COVID-19 development efforts on the recombinant vaccine candidate
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- Category: Sanofi
Recent positive interim results of Sanofi's mRNA-based COVID-19 vaccine candidate Phase 1/2 study confirm the company's platform robust capabilities and strategy in mRNA.
Taking into account public health needs and given sufficient mRNA COVID-19 vaccines supply can be expected going forward, Sanofi has decided not to pursue the development of its COVID-19 mRNA candidate into a Phase 3 clinical study and will focus on completing the final development steps of its COVID-19 recombinant vaccine, developed in partnership with GSK.
Boehringer Ingelheim acquires Abexxa Biologics to further expand its research efforts in cancer immunology and novel immunotherapeutic approaches
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- Category: Boehringer Ingelheim
Boehringer Ingelheim announced the acquisition of Abexxa Biologics Inc., a biopharmaceutical company taking a new approach in the fields of immuno-oncology and oncology research to develop the next generation of precision medicines designed to revolutionize cancer treatments.
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.
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