Search Results for: anticipated spike

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–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 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of … [Read more…]

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union

CHMP recommendation based on favorable data from Omicron-adapted vaccines The Omicron BA.4/BA.5 bivalent COVID-19 booster vaccine combines 15-ug of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccines and 15-ug of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants Pfizer-BioNTech bivalent Omicron BA.4/BA.5 COVID-19 vaccine is available to … [Read more…]

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine The Omicron BA.1-adapted bivalent COVID-19 vaccine combines 15-µg of mRNA encoding the SARS-CoV-2 wild-type spike protein which is in the Original Pfizer-BioNTech COVID-19 Vaccine with 15-µg of mRNA encoding the spike protein of the Omicron … [Read more…]

Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older

Authorization based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines Pfizer-BioNTech Omicron BA.4/BA.5 Bivalent Vaccine combines 15-µg of mRNA encoding the wild-type spike protein found in the Original Pfizer-BioNTech COVID-19 Vaccine and 15-µg of mRNA encoding the spike protein of the OmicronBA.4/BA.5 subvariants Pfizer-BioNTech Omicron BA.4/BA.5 COVID-19 Bivalent Vaccine available to ship immediately … [Read more…]

 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine

Submission follows application for Omicron BA.1-adapted bivalent vaccine submitted in July If authorized, both Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent vaccines will be available in the European Union as early as September NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the … [Read more…]

Oragenics Announces Favorable Preliminary Toxicology Data for Intranasal COVID-19 Vaccine Candidate

N T-CoV2-1 preliminary data supports regulatory filings for Phase 1 studies Intranasal administration elicits immune responses TAMPA, Fla.–(BUSINESS WIRE)–Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced favorable preliminary results from its ongoing Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile … [Read more…]

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine

Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older Companies have rapidly scaled production and stand ready to deliver doses of Omicron BA.4/BA.5-adapted bivalent vaccines for September, and will begin shipping immediately pending authorization Rolling submission for … [Read more…]

Applied DNA Biotherapeutics Subsidiary Reports LinearDNA™ Platform Development Milestone: First Successful Administration of LinearDNA In Vivo via Lipid Nanoparticles (LNP)

– Use of LNP Simplifies Administration of LinearDNA-based Therapies, Potentially Enabling Their Application in Large Scale – STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #LNP—Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, today announced that LineaRx, the Company’s majority-owned biotherapeutics subsidiary, has for the first time successfully administered and expressed a linearDNA-LNP … [Read more…]

Insulet Announces Full Market Release of Omnipod® 5 Automated Insulin Delivery System

Omnipod 5 is Now Fully Available through Retail Pharmacy Channels ACTON, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced its Omnipod® 5 Automated Insulin Delivery (AID) System (Omnipod 5) is now fully available through U.S. retail pharmacy channels … [Read more…]

Immunome’s COVID-19 Cocktail Retains Neutralizing Activity Against the Most Prevalent Omicron Subvariants* in the US, BA.4/5 and BA.2.12.1

IMM-BCP-01 neutralized BA.4/.5 and BA.2.12.1 subvariants in pseudovirus testing IMM-BCP-01 currently in Phase 1b clinical testing with topline data expected in 2H 2022 EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced that their cocktail (IMM-BCP-01) retained activity … [Read more…]