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Evonetix, imec Partner on Chip-Based Technology Scale-Up
The partners will collaborate on developing scale-up chip-based technology to enable commercial-scale production of a third-generation DNA synthesis platform.
MilliporeSigma’s New Microbial Bioburden Testing System Offers Enhanced Results and Increased Productivity
The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.
Otsuka, PhoreMost Team Up for Drug Discovery
Otsuka will use PhoreMost’s phenotypic screening platform to identify new targets for drug development, with a focus on gene therapy.
Daiichi Sankyo Licenses ERS Genomics’ CRISPR Gene Editing Tech
The license gives Daiichi Sankyo access to ERS Genomics’ genome-editing technology for internal R&D initiatives.
Jones Packaging Becomes Jones Healthcare After 100 Years in Health and Wellness
The company announced it will be unveiling a new name, Jones Healthcare Group, and a new corporate logo as it celebrates 100 years in the health and wellness markets.
Johnson & Johnson to Develop a Vaccine Candidate Against Novel Coronavirus
J&J’s Janssen Pharmaceutical Companies seeks to develop a vaccine candidate against the novel coronavirus.
WuXi Biologics Announces Development of Neutralizing Antibodies for Novel Coronavirus
WuXi’s R&D team will be developing and manufacturing 2019-nCoV-neutralizing antibodies at the company's four GMP facilities.
Vetter Combines Laboratory Portfolio into Single Site
The new 1800-m2 building houses more than 50 employees and features non-GMP laboratory space and a GMP analytical laboratory.
Lonza Expands Partnership with Rocket Pharmaceuticals for Childhood Disorder Treatment
Clinical manufacturing of the therapy will take place at Lonza's Houston, TX, and Netherlands cGMP manufacturing sites.
The Discovery Labs, Deerfield Management Create New CDMO and Invest $1.1 Billion in New Cell and Gene Therapy Facility
The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.
FDA Promotes Gene Therapy with New Guidance Documents
The agency has published seven guidance documents directed at the development and manufacture of gene therapies.
Eli Lilly to Invest $470 Million into New Pharma Manufacturing Facility
The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.
AAPS Announces New Executive Director
Tina Morris will be taking on the role of executive director for AAPS.
EMA Celebrates 25th Anniversary
The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.
Guidance Explains User Fee Structure for Biosimilars
The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.
EMA Approves Production Facility for Pharming’s Lead Product
As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.
CGT Catapult Partners with the University of Hertfordshire for Cell and Gene Therapy Course
The new course is directed at analyzing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale.
BIA and Informa Pharma Intelligence Announce UK Biotech Raised $1.7 billion in 2019
The amount was the third highest year recorded and investment has increased more than 400% since 2012.
Novartis Announces EC Approval of MS Drug
The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.
Vanrx Partners and G-CON Launch New Turnkey Facility
The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.
Bio-Techne, Fresenius Kabi, Wilson Wolf Form Joint Venture for Cell and Gene Therapy
The new company will work to provide the manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies through individual company products and expertise.
FDA Completes Successful Pre-Approval Inspection at LSNE Facility
The facility is now equipped to handle commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.
Tedor Announces New Regional Business Development Director
Frank Sorce will be taking on the role of regional business development director for Tedor Pharma.
Astellas, Adaptimmune Form Cell Therapy Pact Worth Up to $897.5 million
The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.
EMA Evolves Approach to Data Use
The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.
GE Builds Single-Use Kit Manufacturing Facility in Switzerland
GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.
Drug Prices: Revisiting the Social Contract
While the US public and law makers push for price controls, pharma’s venture capitalists have other ideas for balancing innovation and affordability.
Quality Oversight Failures Found at New Jersey Facility
FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.
Nationwide Children’s Hospital Forms Gene Therapy Company, Andelyn Biosciences
The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.
Horizon Discovery Grants Access to Base Editing Technology
The next-generation gene editing system can be applied to the development of novel cell and gene therapies.
