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GlobalData Reports on Humira Biosimilars Uptake in EU
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
Lonza to Invest in Mid-Scale Biologics, Cell Therapy Manufacturing
Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.
New Processing System Streamlines Cell Therapy Manufacturing
GE Healthcare’s new Sefia S-2000 cell processing system allows operators to conduct multiple cell therapy manufacturing steps with one instrument.
Avid Bioservices Expands Process-Development Capabilities
The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.
WuXi Biologics to Invest $389 Million in New Biomanufacturing Facility
The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.
Haselmeier, Common Sensing to Partner on Injectable Solutions
The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.
Pandemic Fears Stoke Calls for New Vaccines and Global Health Initiatives
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
Fresenius Terminates $4.3-Billion Merger with Akron
Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.
Biogen, Ionis Expand $1-Billion Neurological Disease Alliance
The companies plan to advance programs for dementia and other neurological conditions.
Astellas Sells Research Facilities to Gilead’s Kite Pharma
As Astellas Pharma winds down its Agensys research operations, the company sells the Santa Monica, CA, facility to Gilead.
Wyatt Technology Announces Executive Team Changes
Geofrey Wyatt has been named CEO and Clifford Wyatt named president of Wyatt Technology.
Data Integrity Failures and Other CGMP Violations Found at China Facility
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
USP Drops Biologics Naming Proposal
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
EMA Updates Flu Vaccine Recommendations
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
Pfizer Receives CRL for Biosimilar to Roche’s Herceptin
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
Selexis SA Invests in New Lab Equipment and Personnel
The company’s investment in new laboratory equipment and personnel will strengthen its cell line development services.
Nelson Labs Expands Lab Operations and Testing Capabilities
The company doubled capacity for laboratory services at its facility in Itasca, IL.
Thermo Fisher Showcases New Equipment at Analytica 2018
The company showcased newer products and equipment for cell culture laboratories at Analytica 2018 in Munich, Germany.
EMA and the Netherlands Finalize Seat Agreement
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
CRISPR Shows Promise for Enhancing Gene Therapy
Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.
Possible Cell Therapy Treatment for Alzheimer's Disease
Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.
Patheon Doubles Biologics Capacity at St. Louis Facility
Thermo Fisher Scientific invests $50 Million to expand biologics drug development and manufacturing capabilities in St. Louis, MO.
Sanofi Buys Berkeley Lights’ Cell Line Platform
The new platform is expected to speed up cell line development.
FDA Seeks to Advance Treatments for Opioid Use Disorder
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
LNC Therapeutics Appoints New CEO and Advances Microbiome-Based Drug R&D
LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.
CDER Publishes Drug Safety Report
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
WuXi AppTec Expands Drug Development Testing Services
The expanded Laboratory Testing Division, located in Cranbury, NJ, will expand the company’s testing services in the United States.
Sanofi to Divest European Generics Business in Deal Worth $2.4 Billion
Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.
Merck KGaA to Sell Consumer Health Biz to Procter & Gamble for $4.2 Billion
The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.
FDA Publishes Q&A on GMPs for APIs
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
