Articles

The company has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms.

Lonza to Divest its Specialty Ingredients Business and Operations for $4.2 Billion

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus. 

FDA Outlines Strategy to Address Virus Variants

Through the agreement, Catalent will manufacture Trizell’s Phase I cell therapy for the treatment of micro- and macroangiopathies at its Belgium facility. 

Catalent to Partner with Trizell for Cell Therapy Manufacturing 

The study found that more than 90% of packages and cases scanned at three companies met all of the labeling requirements, with three years remaining until the final DSCSA deadline in 2023.

GS1 Healthcare Study Shows the Pharmaceutical Industry is Making Progress Toward Interoperability

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

FDA Sets Date for Advisory Meeting to Discuss Janssen COVID-19 Vaccine EUA

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

Syntegon Validates First AI-Equipped Visual Inspection System in Production Line

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

Avid Bioservices Enters Manufacturing Agreement with Humanigen for Lenzilumab

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

PathoQuest Joins CAACB Consortium as Viral Safety Expert

Catalent will offer materials from its gene therapy facilities in Maryland to support IND-enabling studies and a Phase I/II clinical trial of the product.

Catalent and Decibel Team Up to Develop Gene Therapy for Congenital Hearing Loss

Through the acquisition, Jazz will gain access to GW’s novel cannabinoid platform, including Epidiolex, a plant-derived cannabinoid medicine for the treatment of high-growth childhood-onset epilepsy.

News