BioPharm International Editors

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

Be The Match BioTherapies and TrakCel have announced a collaboration to provide integrated solutions for companies developing cell and gene therapies.

IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.

Biotech company Genmab signed an agreement with Johnson & Johson’s Janssen Biotech to develop a monoclonal antibody product using Genmab’s HexaBody technology.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.

Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

The US Federal Trade Commission (FTC) has requested additional information from Roche and Spark Therapeutics regarding Roche’s pending $4.3-billion acquisition of Spark.

GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.

The Michelson Medical Research Foundation and the Human Vaccines Project have awarded three young scientists $150,000 for their novel approaches toward human immune system research.

Dassault Systèmes, a provider of virtual universes to imagine sustainable innovations, has signed a definitive agreement to acquire Medidata Solutions in an all-cash transaction.

ABPI has published a guide for pharmaceutical companies on how to work successfully, collaboratively, and ethically with patients and patient groups, in line with the ABPI Code of Practice.

Vida International received an FDA warning letter after an inspection found quality control violations.

The companies will form a biometrics organization focused on delivering analytical solutions for drug development.

The acquisition will boost Merck’s pipeline for cancer, fibrosis, and autoimmune disease therapeutics.

In this collaboration, AbCellera will apply its expertise to generate panels of antibody candidates for Gilead to evaluate.

The acquisitions, totaling $50 million, are expected expand Aptar Pharma’s service offerings to support complex product development.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

The current president of Novartis’ Advanced Accelerator Applications has been appointed as the new Novartis Pharmaceuticals president.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.

Paul Hudson, formerly CEO of Novartis Pharmaceuticals, has been tapped to succeed Olivier Brandicourt as CEO of Sanofi.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO in Philadelphia.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.