Quality Systems

Nov 01, 2018
BioPharm International
Industry is searching for ways to deal with the criticality of ensuring data integrity.
Nov 01, 2018
BioPharm International
Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
Nov 01, 2018
BioPharm International
Survey results and record attendance may show positive signs for established and emerging biopharma regions.
Oct 31, 2018
By BioPharm International Editors
A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.
Oct 30, 2018
By BioPharm International Editors
The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
Oct 30, 2018
By BioPharm International Editors
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
Oct 23, 2018
By BioPharm International Editors
Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Oct 19, 2018
BioPharm International
To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.
Oct 19, 2018
By BioPharm International Editors
The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indications.
Oct 18, 2018
The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.
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