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Cambrex Announces Expansion of Scottish Solid-Form Screening Facility
Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.
Bayer Recalls Product Due to Mislabeling
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
EMA Recommends Gilenya Not be Used in Pregnancy
EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.
ISA Announces Founding Members of Global Cybersecurity Alliance
Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.
Olon Constructs Fermentation Facility in Italy
Olon began construction of a GMP facility for biologic APIs in Capua, Italy.
CURE Pharmaceutical Receives Patent for Oral Thin Film Technology
Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.
Hikma and Civica Rx Sign Long-Term Agreement to Reduce US Generic Drug Shortages
Hikma will supply 14 essential medicines to US hospitals and patients.
High-Recovery Workflow Solutions for Biological Products
The new ready-to-use, packaging and production workflow solutions from DWK Life Sciences feature NextGen V and E-Z Ex-Traction vials to enhance security and minimize waste.
Cytena Establishes Subsidiary in Taiwan
Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.
Jubilant Cadista Pharmaceuticals Recalls One Lot of Drospirenone and Ethinyl Estradiol Tablets
Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets because of concerns regarding product efficacy.
FDA Approves Nine Generic Versions of Lyrica
The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.
AQbD, the Evolution of Pharmacopoeial Standards?
MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
Safe and Sound with Radio-Frequency
As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?
Clinical Review Leads to Discontinuation of Investigation into BACE Inhibitor for Alzheimer’s Prevention
Novartis, Amgen, and Banner have announced their decision to discontinue the investigation into the BACE1 inhibitor CNP520 (umibecestat) as a preventative therapy for Alzheimer’s disease.
Partnership Addresses Rift Valley Fever Vaccine
The Coalition for Epidemic Preparedness Innovations is partnering with Colorado State University to develop a single-dose vaccine candidate against Rift Valley Fever.
MHRA Issues Drug Alert for Emerade Adrenaline Auto-Injector Device
MHRA has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.
New Showroom Opens at Groninger Headquarters
Development and manufacturing machine specialists, groninger, have opened a new showroom at its headquarters based in Crailsheim, Germany.
Catalent Biologics Announces Long-Term Strategic Agreement to Develop Zolgensma
Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
Lonza Selects Rockwell Automation for Digital Transformation of Capsule Manufacturing
Lonza plans to implement MES software to accelerate paperless, 24/7 production of drug capsules.
TrendMiner and Process Automation Solutions Partner to Accelerate Customers' Digital Transformation
Process Automation Solutions becomes the latest partner to join the TrendMiner ecosystem.
Sartorius Stedim Biotech Launches Single-Use Vessel for ambr 250 Modular Bioreactor
Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.
Bosch Transfers Packaging Technology Business to CVC
The Bosch packaging machinery business, including the pharma unit, will remain intact in the transfer to private equity firm CVC.
Abcam Acquires EdiGene’s Entire Live Cell Lines and Lysates Portfolio
Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.
Catalent Breaks Ground at $112-Million Drug Product Manufacturing Facility
Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.
FDA Enforcement Under Trump: CDER Actions Up, but Overall Warnings Down
A July article in Science suggests that FDA enforcement activities have dropped significantly during the current US presidential administration.
Management Support Crucial to AI in Pharma
Recent studies show that more companies are evaluating or using AI, and that top-down management support is a driving force.
USP to Provide Free Access to Quality Standards for AACP Students
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
FDA Withdraws Approval of 31 ANDAs from Apotex
cGMP deficiencies prompted FDA to withdraw approval for 31 Apotex ANDAs
Altaire Pharmaceuticals Recalls Multiple Ophthalmic Products
Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.
