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Alligator Bioscience Enters into License Agreement with Biotheus
The agreement gives Biotheus access to Alligator’s antibody, Alligator-Gold, for the creation of up to three bispecific molecules.
EAG Launches New Lab in China for Product Improvement
The new lab will be dedicated to improving materials and electronics using advanced imaging and surface analysis expertise.
Bayer to Sell Animal Health Biz to Elanco for $7.6 Billion
The divestiture is in line with Bayer’s strategy to focus on its life sciences business.
Data Integrity Violations Found at China Facility
FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.
Enable Injections Enter into Development Agreement with Genentech
The companies will work together to produce enFuse, a patient-administered subcutaneous delivery device.
Pfizer Invests $500 Million into Its Gene Therapy Facility
Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.
ACG Capsules Introduces New Line of HPMC Capsules
The ACGcaps H+ capsules work to meet pharmaceutical and nutraceutical needs while remaining gelatin-free.
Parker Bioscience Filtration Expands Single-Use System Facility in UK
The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.
Olympus to Present Light Microscopy Award
Olympus will launch its first Global Image of the Year Life Science Light Microscopy Award to recognize life science imaging.
Boehringer Ingelheim and MD Anderson Partner on Virtual Center for Cancer Therapies
The partnership aims to establish a virtual R&D center to advance the development of new cancer therapies.
India Facility Receives Warning Letter
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
European Commission Extends Use of Dupixent to Include Adolescents
The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.
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.