FDA Advisory Committee Recommends Emergency Use Authorization of Pfizer’s/BioNTech’s COVID-19 Vaccine
By

By
An advisory committee of the US Food and Drug Administration (FDA) met this week (December 10, 2020) to review the request by Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company,…

Pharma COVID Roundup: News from Moderna, AstraZeneca, Lilly, Roche
By

By
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from Moderna, AstraZeneca, Lilly, Roche, Thermo Fisher, Inovio, Sinovac, and others. Manufacturing and supply of COVID-19 vaccines and…

Global Pharma Briefs: News from AstraZeneca, Takeda, Sanofi, BioNTech
By

By
A roundup of news from France (Sanofi), Germany (BioNTech), Japan (Takeda), the UK (AstraZeneca), and the US (Aurobindo). France Sanofi, Kiadis Pharma Update on $358-M AcquisitionSanofi and Kiadis Pharma, an…

Pfizer’s/BioNTech’s COVID-19 Vaccine Gets OK from UK for Emergency Use
By

By
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have received approval for emergency use of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2, the virus that causes COVID-19, by the UK’s…

Moderna Files for Emergency Use, Conditional Approval to FDA, EMA for COVID-19 Vaccine
By

By
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has filed requests for an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) and…

Pharma COVID Roundup: News from J&J, Takeda, Amgen, Regeneron
By

By
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from J&J, Takeda, Amgen, UCB, Regeneron, Novavax, Roche, Inovio, and Kaneka. Manufacturing and supply of COVID-19 vaccines and…

Pharma COVID Roundup: News from Moderna, Lilly, AstraZeneca
By

By
The latest on manufacturing and potential treatments for COVID-19 with news from Moderna, Eli Lilly and Company, AstraZeneca, the World Health Organization, and others. Manufacturing and supply of COVID-19 vaccines…

Pfizer, BioNTech Submit EUA to FDA for COVID-19 Vaccine
By

By
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, reported that they have submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of their…

Pharma COVID Roundup: News from Bausch, Inovio, and the FDA
By

By
The latest on manufacturing and potential treatments for COVID-19 with news from Bausch Health, Inovio, the FDA, Bharat Biotech, and the Medicines Patent Pool. Manufacturing and supply of COVID-19 vaccines…

Pfizer, BioNTech To Submit EUA Request to FDA for COVID-19 Vaccine
By

By
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have achieved the safety data milestone required by the US Food and Drug Administration (FDA) for submission of emergency use authorization (EUA)…