Novartis has resubmitted to the US Food and Drug Administration (FDA) its new drug application (NDA) for inclisiran, a potential blockbuster drug for treating certain types of high cholesterol, to…
Pharma COVID Roundup: News from Moderna, AstraZeneca, and Roche
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, AstraZeneca, Roche, J&J, Pfizer, Novavax, CureVac, Sinovac, and Thermo Fisher. Manufacturing and supply of COVID-19 vaccines and drugs EMA OKs…
FDA Issues Report on Drug Shortages, Including Impact of Mfg
The US Food and Drug Administration (FDA) has issued its annual report on drug shortages by outlining the extent of drug shortages in calendar year 2020 and the steps the…
Sanofi Launches Dedicated mRNA Center of Excellence
Sanofi has launched a dedicated mRNA Center of Excellence with a planned annual commitment of approximately EUR 400 million ($475 million) to develop and deliver mRNA vaccines. The center will…
Amgen has announced plans to expand its US-based manufacturing footprint by building a new final product advanced assembly and packaging plant near Columbus, Ohio. Plant construction is slated to begin…
Global Pharma Briefs: News from J&J, Novartis, Sanofi, and BMS
A roundup of news from Belgium (Legend Biotech, J&J), Canada (AbCellera), China (Frontera Therapeutics), Ireland (Horizon Therapeutics), Switzerland (Novartis), the UK (Exscientia), and the US (Sanofi, BMS, others). Belgium Legend…
Pharma COVID Roundup: News from AstraZeneca, Gilead, and GSK
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from AstraZeneca, Gilead, GSK, Vir, Novavax, Celltrion, and Thermo Fisher Scientific. Manufacturing and supply of COVID-19 vaccines and drugs Court Rules on…
Moderna Ups EU Supply of COVID-19 Vaccine; Updates Mfg and Staffing
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, reports that the European Commission has purchased an additional 150 million doses of its COVID-19 vaccine. Also, the company…
Pharma COVID Roundup: News from J&J, AstraZeneca, and Pfizer
The latest on COVID-19 vaccines/drugs and manufacturing from J&J, AstraZeneca, Pfizer, Novavax, Regeneron, CureVac, Daiichi Sankyo, and the US government. Manufacturing and supply of COVID-19 vaccines and drugs Update on…
US Gov’t Purchases Additional 200 M Doses of Moderna’s COVID-19 Vaccine
The US government has purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, and the European Medicines Agency (EMA) has approved a new manufacturing site for the vaccine. Moderna…