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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FDA Releases Draft Guidance on Population Pharmacokinetic Analysis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FDA Releases Draft Guidance on Using the Inactive Ingredient Database
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.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FDA released draft guidance on using the USP pending monograph process in the drug application process.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.
Bristol-Myers Squibb, Draper to Develop Liver Tissue Model
The companies will work to develop a liver tissue model for screening the toxicity of drugs.
Catalent Biologics Acquires Vaccine Manufacturing Facilities
Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.
Gottlieb Elected to Pfizer’s Board
Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.
International Survey Uncovers Challenges in Laboratory Workflows
A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.
Sartorius’ New Flow Cytometer Offers Fully Automated Cell Processing
The new flow cytometer offers full automation and enhanced software to alleviate bottlenecking.
FDA Challenges USP Standards for Biologics
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
AbbVie Announces $63 Billion Allergan Acquisition
In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.
FDA Approves Amgen and Allergan's Biosimilar to Herceptin
The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.
Piramal Pharma Solutions Invests $10 million to Expand HPAPI Capability
The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.
