All
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.
Lonza Expands HPAPI Capacity
Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.
Pfizer to Acquire Array BioPharma
Pfizer’s acquisition of Array BioPharma expands the company’s pipeline of investigational cancer therapies.
SenzaGen Gains First Patent for GARDpotency
SenzaGen has revealed that is has been granted a patent in Europe for GARDpotency, a testing application that enables the measurement of the allergenicity of chemical substances without animal research.
MHRA Issues Class 2 Medicines Recall Drug Alert
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.
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.
Sphere Fluidics Secures a Total of $4.8 million in Funding
Sphere Fluidics has secured a total of $4.8 million (£3.7 million) in investment after closing its additional tranche investment work $2.9 million (£2.2 million).
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.
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.
Study Results Demonstrate Early Cardio-Renal Effects of AstraZeneca’s Farxiga
Recently presented and published study results have demonstrated the ability of AstraZeneca’s Farxiga on reducing the progression of kidney disease or renal death in type-2 diabetes.
OGT Expands Product Portfolio with Complete Library Preparation Solution
OGT has announced the expansion of its SureSeq portfolio with a complete library preparation solution for hybridization-based target capture in NGS.
Merck Holds Groundbreaking Ceremony for Formulation Laboratory and Experimental Center
A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.
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.
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.
Aptar Acquires Nanopharm and Gateway Analytical
The acquisitions, totaling $50 million, are expected expand Aptar Pharma’s service offerings to support complex product 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.
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.
New York Facility Receives FDA Warning Letter
Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.
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.
Novartis Announces New Head of Pharmaceuticals Business Unit
The current president of Novartis’ Advanced Accelerator Applications has been appointed as the new Novartis Pharmaceuticals president.
Biogen Completes $800-Million Acquisition of Nightstar Therapeutics
The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.
Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.
Tergus Pharma Plans Commercial Manufacturing Facility
Tergus Pharma announced a partnership with Great Point Partners and construction of a new commercial manufacturing facility in North Carolina.
Former Novartis Pharma Business Head Takes on CEO Mantle at Sanofi
Paul Hudson, formerly CEO of Novartis Pharmaceuticals, has been tapped to succeed Olivier Brandicourt as CEO of Sanofi.
Massachusetts Company Receives Warning Letter
Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.
Cambrex Completes New Facility at Swedish Manufacturing Site
Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.
Consultation Opens on EMA’s Draft Guidelines on Drug-Device Combination Products
EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.
New UK Life Sciences Asset Launches at BIO
A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO in Philadelphia.