Pharmaceutical Technology Editors

The European Medicines Agency has launched a full investigation into a cyberattack.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

The collaboration includes the development, commercialization, and supply of Orgenesis’ pipeline in South Korea and Japan and the development and commercialization of Cure Therapeutics’ pipeline on a global basis.

Through the acquisition, PTI will gain access to LDA’s lead product, the SIMS 1915+, a helium leak test system that combines its helium leak detection technology with its SIMS software for data collection and analysis.

The company has received $500 million in funding from Sino Biopharmaceutical for further development, capacity expansion, and manufacturing of CoronaVac, its COVID-19 vaccine candidate.

CDMO HALIX will manufacture the drug substance for AstraZeneca’s COVID-19 vaccine candidate, AZD1222, at commercial scale at its cGMP facility in the Netherlands.

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.

The company will expand its micronization abilities for highly potent drug compounds through this investment.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

The product is being recalled because of Burkholderia cepecia contamination.

A development agreement will study inhaled formulations of cannabinoid-based drug product for central nervous system diseases.

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.

The virtual showroom will provide real-time construction updates, various specs, and services that its new super plant, Plant 4, will offer upon completion.

The companies have entered into an agreement for next-generation, mesothelin-directed CAR-T cell therapies for the treatment of solid tumors.

Startup company Vivlion has signed a non-exclusive license agreement with ERS Genomics granting access to CRISPR/Cas9 patent portfolio.

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.

Lonza has formed a long-term, strategic collaboration with a global biopharma company for bioconjugation.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

The gene therapy increases the ability of retina cells to make a soluble form of CD59, a protein that shields the retina from damage, to prevent additional damage and to preserve vision.

Set to be operational by the first quarter of 2022, the 140,000-ft2 facility will feature up to six 2000-L, single-use bioreactor systems along with additional harvest and purification equipment to produce up to 100 commercial batches annually.

Under the terms of the partnership, Colorcon will work to accelerate i2O’s research and development efforts.

The grant will support the advancement of glycoengineering technology for plant-derived proteins developed by a University of Alberta scientist partnered with PlantForm.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

The announcement comes after the company saw growth and performance in Asia and decided to continue the expansion of biopharmaceutical manufacturing in the region.

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.