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Bristol-Myers Squibb, Draper to Develop Liver Tissue Model
The companies will work to develop a liver tissue model for screening the toxicity of drugs.
Catalent Biologics Acquires Vaccine Manufacturing Facilities
Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.
Gottlieb Elected to Pfizer’s Board
Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.
International Survey Uncovers Challenges in Laboratory Workflows
A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.
Sartorius’ New Flow Cytometer Offers Fully Automated Cell Processing
The new flow cytometer offers full automation and enhanced software to alleviate bottlenecking.
FDA Challenges USP Standards for Biologics
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
AbbVie Announces $63 Billion Allergan Acquisition
In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.
FDA Approves Amgen and Allergan's Biosimilar to Herceptin
The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.
Piramal Pharma Solutions Invests $10 million to Expand HPAPI Capability
The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.
Partnership Forms to Standardize Cell and Gene Therapy Supply Chain Solutions
Be The Match BioTherapies and TrakCel have announced a collaboration to provide integrated solutions for companies developing cell and gene therapies.
IVERIC bio, Catalent Partner on Gene Therapy for Orphan Inherited Retinal Diseases
IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.
Genmab, Janssen Partner for Next-Generation mAb Antibody
Biotech company Genmab signed an agreement with Johnson & Johson’s Janssen Biotech to develop a monoclonal antibody product using Genmab’s HexaBody technology.
Lonza, Gamida Cell Form Commercial Cell-Therapy Manufacturing Pact
The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.
Sanofi, Google to Develop New Healthcare Innovation Lab
The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.
Catalent to Purchase BMS Manufacturing Site in Anagni, Italy
Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.
LSNE Expands to Europe with Acquisition of Facility in Spain
Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.
CPI to Showcase Results of Biologic Drug Development Collaboration
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.
Will Congress Enact Curbs on Drug Pricing?
Congress is weighing in on drug pricing with a range of measures that differ in style and substance.
FTC Requests Info for Roche’s $4.3-Billion Acquisition of Spark Therapeutics
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, University of California Collaborate on CRISPR Technologies
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.
2019 Michelson Prize Winners Announced
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 to Acquire Medidata Solutions
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.
Industry Publishes a Guide for Companies Working with Patients
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.
Taiwan Facility Receives FDA Warning Letter
Vida International received an FDA warning letter after an inspection found quality control violations.
Cytel, Axio Unite for Analytical Solutions
The companies will form a biometrics organization focused on delivering analytical solutions for drug development.
Merck & Co. to Acquire Tilos Therapeutics in Deal Worth Up to $773 Million
The acquisition will boost Merck’s pipeline for cancer, fibrosis, and autoimmune disease therapeutics.
Gilead, AbCellera in Therapeutic Antibody Discovery Collaboration
In this collaboration, AbCellera will apply its expertise to generate panels of antibody candidates for Gilead to evaluate.
Aptar Acquires Nanopharm and Gateway Analytical
The acquisitions, totaling $50 million, are expected expand Aptar Pharma’s service offerings to support complex product development.
Luxembourg and the Netherlands Added to EU–US Inspections Agreement
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.
FUJIFILM Invests in New Continuous Processing Facility
The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.
