News

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.

FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.

SGS announces expansion of cell bank and bulk harvest testing services.

CDMO leader Marc Funk will succeed Ridinger as CEO of Lonza.

Parker Bioscience Filtration added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.

Merck & Co.’s V920 (rVSV-ZEBOV) vaccine is expected to pave the way for the development of vaccines for emerging infectious disease with unpredictable disease incidence or geography, according to data and analytics company, GlobalData.

The US and pharmerging markets will drive growth in drug spending; number of approvals to increase.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

Horizon and Rutgers University will partner to develop and commercialize new gene editing technology for therapeutic and research applications.

TC BioPharm (TCB), developer of CAR-T immuno-oncology products, has completed its first allogenic Gamma Delta T (GDT) cell banks.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

G-CON will provide a complete cleanroom infrastructure for GE Healthcare’s cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.

Lonza’s PyroTec PRO system combines robotic liquid-handling technology with an automation software module.

Company to focus on innovation, growth, and productivity with creation of new units.

The company has built a fit-for-purpose liquid chromatography–mass spectrometry (LC–MS) system to streamline analytical monitoring tests for biopharmaceuticals.

The companies will embark on a multi-year research collaboration to develop in-vivo delivery modalities for CRISPR/Cas9 by leveraging ProBioGen’s existing technology and expertise.

The acquisition of biopharmaceutical company TESARO is expected to strengthen GSK’s oncology pipeline and commercial footprint.

MilliporeSigma’s use of modified amino acids can simplify the fed-batch process in biomanufacturing.

Taconic Biosciences, a provider of genetically engineered rodent model solutions, sent mice into space to advance research on new therapies for aging-related disease processes.

Dublin, Ireland-based biopharmaceutical company Allergan will establish an R&D presence in Cambridge, MA.

Solentim and ATUM have announced a technology collaboration agreement that will focus on the creation of an efficient cell line development solution for biotherapeutic drug developers.

Univercells, a business-to-business provider focused on biologics, has commercially launched its proprietary bioproduction system, NevoLine.

Cell and gene therapy platform company, Locate Bio, has announced that it is set to receive key patents for its IntraStem technology covering the United States and Europe

A strategic collaboration has been formed between 4D pharma and The University of Texas MD Anderson Cancer Center.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has made two significant changes to its new 2019 Code of Practice with the aim of boosting business integrity on a global scale.

The companies will offer an IT platform that enhances the visibility and performance of the overall personalized medicine treatment process.

The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.