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Abcam Acquires EdiGene’s Entire Live Cell Lines and Lysates Portfolio
Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.
Sartorius Stedim Biotech Launches Single-Use Vessel for ambr 250 Modular Bioreactor
Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.
Catalent Biologics Announces Long-Term Strategic Agreement to Develop Zolgensma
Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
Catalent Breaks Ground at $112-Million Drug Product Manufacturing Facility
Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.
FDA Releases Guidance on Electronic Submissions
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
USP to Provide Free Access to Quality Standards for AACP Students
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
Connecticut Manufacturer Gets FDA Warning Letter
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
Gilead and Galapagos Announce Global R & D Collaboration
Gilead Sciences gains rights to clinical and preclinical programs in Galapagos’ portfolio through a 10-year global research and development collaboration.
Boehringer Ingelheim Acquires Immunotherapy Platform
Boehringer Ingelheim will combine assets from its cancer immunology portfolio with the KISIMA immunization platform from AMAL Therapeutics.
New Cleanroom Facility Built at ADC Bio
The new cleanroom, designed and built by WHP, is part of ADC Bio’s new bioconjugation facility in the UK.
ADC Therapeutics Closes Series E Financing Expansion
Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.
MES Planned for Cell and Gene Therapy Applications
Werum IT Solutions will provide a standardized, scalable, and compliant platform to blood centers for the cell and gene therapy processes.
US and Europe Reach Mutual Recognition Agreement Goal on Inspections
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
FDA Releases Draft Guidance on Population Pharmacokinetic Analysis
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
JSR Life Sciences Opens Applications Development Facility
The Applications Center of Excellence in Durham, NC, will offer development studies for JSR Life Sciences customers.
Agilent to Acquire BioTek for $1.165 Billion
Agilent Technologies Inc. announced that it signed a definitive agreement to acquire BioTek Instruments, a company that handles the design, manufacture, and distribution of innovative life science instrumentation for $1.165 billion.
FDA Finalizes REMS Guidance
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
FDA Releases Draft Guidance on Using the Inactive Ingredient Database
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
Guidance on the Harmonization of Compendial Standards Published
FDA released draft guidance on using the USP pending monograph process in the drug application process.
Amicus Partners with Catalent on Lysosomal Disease Gene Therapy Programs
Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.
FDA Publishes Guidance on Instructions for Use in Patient Labeling
The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.
Amicus Therapeutics Enters Strategic Manufacturing Collaboration with Thermo
Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.
Proposed Rule Designed to Open Biosimilar Competition
FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.
Industry Continues to Invest Significantly in UK R&D
New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.
Lonza Announces Acquisition of Novartis Drug Product Facility
Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.
Pfizer Completes Acquisition of Clinical-Stage Biotech
Pfizer has successfully completed its acquisition of Therachon, a privately held clinical-stage biotechnology company.
Fujifilm Irvine Scientific Plans to Open New Manufacturing Site in Europe
Fujifilm Irvine Scientific has announced plans to open a third manufacturing facility in Tilburg, The Netherlands.
Source of Nucleic-Acid Asymmetry May Advance Gene Therapy
Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.
Gilead, Carna Biosciences in R&D Collaboration
The companies will join forces to develop new immuno-oncology therapies in a deal worth up to $470 million.
FDA Announces Draft Guidance for Bioanalytical Method Validation
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
