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December 11, 2020
The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.
December 10, 2020
The European Medicines Agency has launched a full investigation into a cyberattack.
December 09, 2020
Dr. Marcus Michel will take over the role from Richard Stedman, who has served as CEO for the past three years, as he transitions to a special advisor role for the company.
December 08, 2020
The product is being recalled because of Burkholderia cepecia contamination.
The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.
The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.
December 04, 2020
New data from CGT Catapult has demonstrated progression by the industry toward commercialization of therapies and an increase in GMP manufacturing space.
A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.
December 03, 2020
A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.