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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.
Be Quick, But Don’t Hurry
After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.
Seeking Regulatory Advice
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Oral Delivery of Macromolecular Drugs
Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.
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.
Data Integrity Issues Found at China Facility
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
Industrial Vacuum Cleaners Receive ATEX Certification
Vac-U-Max received “atmosphères explosibles” or equipment for potentially explosive atmospheres (ATEX) approval for three product ranges of compressed-air-powered vacuums.
Ionic Pill Could Replace Daily Injections for Diabetics
A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.
GE Spins Off Healthcare Unit as Stand-alone Business
Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.
Waters’ New UPLC Platform Meets Evolving Chromatography Needs
The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.
Minakem Opens New High Containment Facility
Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.
FDA Approves First Cannabidiol-based Drug
GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.
ISPE Forms Foundation to Support the Pharma Industry
The International Society for Pharmaceutical Engineering (ISPE) launched its philanthropic division, the ISPE Foundation, to support industry demands.
CellGenix Completes First Step of Facility Expansion for Cell-Culture Reagents
The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.
FDA Publishes User Fee Guidance
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
