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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.
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.
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.
Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements
Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.
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.
EMA Reviews Product from China Facility
The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
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.
Catalent to Acquire Juniper Pharmaceuticals
Catalent’s acquisition of Juniper Pharmaceuticals further expands its early development capabilities.
FDA Releases ANDA Submission Guidance
The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
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.
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.
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.
New Orbitrap ID-X Tribrid Mass Spectrometer Enhances Small-Molecule Characterization
Thermo Fisher Scientific’s mass spectrometer combines mass-analyzer technology with an intelligent data acquisition strategy.
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.
Neostigmine Methylsulfate 5mL Recalled
Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.
Sanofi to Sell European Generics Business for $2.2 Billion
Sanofi will sell Zentiva, its European generics business, to private equity investor Advent International.
Purolite Launches New Protein A Resin
The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.
AbbVie and Calibr Partner on T-cell Therapies
The companies will partner to develop T-cell therapies for cancer.