Category: North America

January 28, 2021 Off

Moderna confirms talking with the US on 100M doses of Cov-19 vaccine

By Dino Mustafić

After the US president’s Biden said the US Federal government would buy 100 million doses of the COVID-19 vaccine from Moderna and another 100 million from Pfizer, Moderna today confirmed that it is in discussion with the U.S. government to purchase an additional 100 million doses of the Moderna COVID-19 Vaccine for delivery in the third quarter of 2021.

January 27, 2021 Off

Teneobio cleared for it’s treatment of mCRPC in USA

By Dino Mustafić

Teneobio, Inc. and its affiliate TeneoThree, Inc. announced today that their investigational new drug application (IND) for TNB-585, a bispecific T-cell engaging antibody for the treatment of metastatic castrate resistant prostate cancer (mCRPC) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on January 23, 2021.

December 19, 2020 Off

Moderna’s COVID-19 vaccine authorized in U.S.

By BusinessWire

U.S. FDA has authorized mRNA vaccine against COVID-19 for emergency use as total of 200 million doses ordered by the U.S government to date, with an option to purchase up to an additional 300 million doses, while approximately 20 million doses will be delivered by the end of December 2020.

December 18, 2020 Off

Mesoblast Update on COVID-19 ARDS Trial

By GlobeNewswire

Mesoblast’s COVID-19 ARDS trial was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care in a trial of 300 patients.

December 17, 2020 Off

Merck’s supplemental BLA in priority review for Keytruda chemotherapy combo

By BusinessWire

The FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction