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Ocean Network Express (ONE) Launches Digital Freight Booking Platform Powered by Descartes ...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Ocean Network Express (ONE) Launches Digital Freight Booking Platform Powered by Descartes .
The Descartes Systems Group Inc.May 11, 2021 GMT
WATERLOO, Ontario, May 11, 2021 (GLOBE NEWSWIRE) Descartes Systems Group (Nasdaq: DSGX) (TSX:DSG), the global leader in uniting logistics-intensive businesses in commerce, announced that Singapore-based Ocean Network Express (ONE), the world’s sixth largest container carrier, is using the Descartes Kontainers solution to digitize the shipper-facing aspects of its freight execution operations in 11 Asian countries as part of a pilot program.
“Shippers today need a more efficient and streamlined end-to-end freight booking experience,” Hiroki Tsujii, Managing Director, Marketing & Commercial said at ONE. “With the launch of our new digital platform ONE QUOTE, powered by Descartes Kontainers, customers can now receive an inst ....

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Pfizer Inc.: Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID-19 Vaccine

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Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today 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. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency. ....

United States , United Kingdom , Sylke Maas , Albert Bourla , Chuck Triano , Amy Rose , Ugur Sahin , Fosun Pharma , Centers For Disease , Drug Administration , Bayer Animal Health , Exchange Commission , Pfizer Inc , European Union , Roche Group , Vaccine Administration Under Emergency Use Authorization , Biologics License Application , Prescription Drug User Fee Act , Emergency Use Authorization , Chief Executive Officer , Marketing Authorization Holder , Coronavirus Disease , Fact Sheet , Healthcare Providers Administering Vaccine , Vaccination Providers , Disease Control ,

Investegate |BioNTech SE Announcements | BioNTech SE: Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine

The Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipients.
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 vaccine during mass vaccination outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 vaccine.
Available data on Pfizer-BioNTech COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. ....

United States , United Kingdom , Sylke Maas , Albert Bourla , Chuck Triano , Amy Rose , Ugur Sahin , Fosun Pharma , Centers For Disease , Drug Administration , Bayer Animal Health , Exchange Commission , Pfizer Inc , European Union , Roche Group , Vaccine Administration Under Emergency Use Authorization , Initiate Rolling Submission , Biologics License Application , Prescription Drug User Fee Act , Emergency Use Authorization , Chief Executive Officer , Marketing Authorization Holder , Coronavirus Disease , Fact Sheet , Healthcare Providers Administering Vaccine , Vaccination Providers ,

BioNTech SE: Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine

BioNTech SE: Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine
Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of May 7, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, a rolling submission of a Biologics License Application (BLA) with the FDA for BNT162b2, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturi ....

United States , United Kingdom , Sylke Maas , Albert Bourla , Chuck Triano , Amy Rose , Ugur Sahin , Fosun Pharma , Centers For Disease , Drug Administration , Bayer Animal Health , Exchange Commission , European Union , Roche Group , Vaccine Administration Under Emergency Use Authorization , Biologics License Application , Prescription Drug User Fee Act , Emergency Use Authorizationby , Chief Executive Officer , Marketing Authorization Holder , Emergency Use Authorization , Disease Control , Adverse Events , Fact Sheet , Mandatory Requirements , Administration Under Emergency Use ,

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID-19 Vaccine

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID-19 Vaccine
Pfizer Inc. and BioNTech SE today announced the initiation of a Biologics License Application with the U.S. Food and Drug Administration for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act …
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today 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. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescrip ....

United States , United Kingdom , Sylke Maas , Albert Bourla , Chuck Triano , Amy Rose , Ugur Sahin , Fosun Pharma , Centers For Disease , Drug Administration , Bayer Animal Health , Exchange Commission , Pfizer Inc , European Union , Roche Group , Vaccine Administration Under Emergency Use Authorization , Biologics License Application , Prescription Drug User Fee Act , Emergency Use Authorization , Chief Executive Officer , Marketing Authorization Holder , Coronavirus Disease , Fact Sheet , Healthcare Providers Administering Vaccine , Vaccination Providers , Disease Control ,