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GNA Biosolutions Closes Latest Financing Round Backed by US/EU Consortium
GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.
Optima Pharma Inaugurates Center for Building Turnkey Plants
Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities.
Nephron and Clemson to Develop Robotics for Syringe Filling
Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.
Industry Responds to UK Government Immigration Rules Proposals
Industry has responded favorably to the recent announcement from the UK's PM that immigration rules should be developed to ensure scientific talent is attracted to the country.
Caladrius Biosciences, Cognate BioServices in Clinical Manufacturing Pact
The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.
FDA Wants Companies to Update Drug Listing Information
The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.
New Jersey Facility Receives FDA Warning Letter
Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
Amgen Wins Enbrel Patent Case, Sandoz to Appeal Ruling
A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).
Samsung Demonstrates Full-Scale ATF Perfusion at Songdo Facility
Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%
Considerations in Demonstrating Interchangeability with a Reference Biologic Product
Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
BioLife Solutions Completes Acquisition of SAVSU Technologies
The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.
Eurofins Genomics Acquires Blue Heron Biotech, Expands Gene Synthesis Capabilities
The acquisition expands Eurofins Genomics’ gene portfolio while bolstering Blue Heron’s production capabilities.
HALIX Completes New cGMP Manufacturing Facility; Startup Slated for Q4 2019
The new facility will manufacture biopharmaceutical products under cGMP conditions.
GSK US Pharma Head Steps Down
Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.
Protein Analyzer Offers Ability to Measure Protein Titer Directly from Bioreactor
The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.
PTC Therapeutics Acquires Biologics Facility from Bristol-Myers Squibb
The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.
Bayer Acquires BlueRock Therapeutics, Boosts Cell Therapy Stake
The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.
South Korea’s Biotech Industry Projected to $23.2 Billion by 2022, According to Industry Report
South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
Sartorius Stedim Biotech Launches New Mammalian Cell Bank Services
The company has launched new services for mammalian cell bank manufacturing under GMP conditions.
FDA Publishes Guidance on Rare Pediatric Disease Priority Review
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
FDA Gives Guidance on Developing Treatments for Fabry Disease
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
FDA Assessing Data Accuracy in Zolgensma Approval
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Monitoring and Control of Inline Dilution Processes
Successful process intensification with inline dilution requires effective monitoring and control.
Drug Importing Back on Center Stage
FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.
NIIMBL and FDA Partner in Biopharmaceutical Manufacturing
NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
Bayer Recalls Product Due to Mislabeling
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
ISA Announces Founding Members of Global Cybersecurity Alliance
Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.
Olon Constructs Fermentation Facility in Italy
Olon began construction of a GMP facility for biologic APIs in Capua, Italy.
Cytena Establishes Subsidiary in Taiwan
Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.
