BioPharm News

Jun 27, 2018
By BioPharm International Editors
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
Jun 26, 2018
By BioPharm International Editors
Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.
Jun 26, 2018
By BioPharm International Editors
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.
Jun 25, 2018
By BioPharm International Editors
GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.
Jun 25, 2018
By BioPharm International Editors
Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.
Jun 25, 2018
By BioPharm International Editors
The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.
Jun 22, 2018
By BioPharm International Editors
The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.
Jun 22, 2018
By BioPharm International Editors
FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
Jun 22, 2018
By BioPharm International Editors
The agency launched a secure online portal for orphan drug designation applications.
Jun 22, 2018
By BioPharm International Editors
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
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