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Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification
The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.
Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies
CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.
Moderna Opens Manufacturing Site for mRNA Therapeutics
Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.
Drugs Containing Valsartan Recalled
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
Otsuka to Acquire Visterra for $430 Million
Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.
Generics Drive Finished Drug Market Growth in Korea
CPhI Korea to feature zone for finished dosage formulation drug products.
FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Catalent Implements Optofluidic Platform for Cell-Line Development
Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.
Teva to Relocate US Headquarters to New Jersey
Teva Pharmaceuticals USA will move its US headquarters to Parsippany-Troy Hills, NJ.
Takeda Receives US Clearance for $62-Billion Acquisition of Shire
The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.
Pfizer Announces Restructuring
Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.
Call for Entries: 2018 CPhI Pharma Awards
Annual awards program recognizes innovation in bio/pharmaceutical drug development and manufacturing.
New Program Aims to Improve Patient Medication Adherence
Progressive Care’s DischargeRX program works with hospitals and patients to help improve patient medication adherence and minimize medication-related hospital readmissions.
MilliporeSigma to Expand UK Operations
The expansion at the company’s Gillingham, UK, site, worth EUR 9 million (approximately US$10.5 million), will improve the company’s distribution capabilities.
EMA Sees Gaps in Pharma’s Readiness for Brexit
Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.
Takeda Opens New Global Headquarters
The company opened its new global headquarters in Japan.
Cross-Industry Expertise Can Promote Manufacturing Improvements
Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.
Sanofi Plans R&D Hub in China
Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.
Biogen to Increase Stake in Samsung Bioepis Joint Venture for $700 Million
Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.
Novartis to Spinoff Alcon Eye Care Device Biz and Initiates $5-Billion Share Buyback
The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.
EMA Recommends First CART-T Cell Therapies
The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.
Entegris Acquires Flex Concepts
The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.
FDA Seeks to Revive Quality Metrics Initiative
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Congress and FDA Take Action to Combat Opioid Crisis
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
Alcami Expands Laboratory Services Program
The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics’s Zilretta (triamcinolone acetonide extended-release injectable suspension).
Hamilton, Waters Partner on Streamlining Sample Preparation Workflows
Hamilton Robotics and Waters Corporation have partnered to develop StarWorks, automated, end-to-end workstations for biopharmaceutical sample preparation.
Sciex’s New Mass Spec Technologies Enhance Lab Analytics
Sciex’s latest additions to its biopharma portfolio helps to optimize workflow for better analytics in the lab.
Thermo Fisher’s Newest Mass Spectrometry Innovations Deliver Better Performance
The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.
Amazon to Acquire Online Pharmacy
Amazon will acquire PillPack, an online pharmacy that offers pre-sorted doses of medications and home delivery.
EDQM Annual Report Showcases 2017 Highlights
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.