AbbVie and Eisai obtain additional approval for Humira
The monoclonal antibody, Humira, is used in the treatment of patients who have had an inadequate response to conventional therapy for pustular psoriasis
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ERT receives sixth consecutive award for outstanding customer service
Remains committed to exceeding expectations, driving high satisfaction
Phoenix Molecular Designs announces manufacturing collaboration with WuXi STA
Phoenix Molecular Designs (PhoenixMD), a privately held biotechnology company designing precise cancer therapeutics by ...
Chinese pharma regulatory reforms will help to attract foreign investment
China is the second largest pharmaceutical market in the world
Clinical evaluation: three actions for improved medical device trials and compliance
The way we plan and conduct clinical investigations for medical devices must be adjusted to 21st century standards
TraceLink unveils EU FMD Express: a purpose-built compliance solution for smaller pharmaceutical companies
TraceLink, the world’s largest track and trace network for connecting the life sciences supply chain and providing real- ...
Bionical Group announces bionical-clinical early access programmes (EAP)
Early Access Programmes (often called Pre-approval Access, Compassionate Use, Named Patient, Expanded Access, Managed ...
Standing strong
As regulatory pressure keeps rising, affecting every aspect of the drug manufacturing process, quality is an ongoing ...
Quay establishes biotherapeutic GMP suites
The UK based pharmaceutical outsourcing specialist continues to invest in its work in live biotherapeutics at its ...
New industry standards group to improve collaboration with sponsors
Align Clinical CRO to create open technology standards that make it easier for life sciences companies and CROs to work ...
Highly potent APIs: hazards in classification and handling
This variability and subjective nature of classification means that the OEL is best considered as a tool for site risk ...
Serialisation: one year and counting
The Falsified Medicines Directive (FMD) introduces pan-European measures to prevent counterfeit medicines from entering ...
Serialisation challenges and opportunities for MAHs and CDMOs
Speaking at FutureLink Munich in June, IBI Lorenzini’s Operations Director, Luca Pezzano, discusses the company’s ...
Domain Therapeutics receives $125m to assign its intellectual property
Domain Therapeutics to receive up to $125 million for assignment of its intellectual property covering the Foliglurax ...
Healthcare professionals express opinions on personal data
Professionals in the healthcare sector want their personal data edited or deleted when GDPR comes in
In Brief
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- European Pharmacopoeia (Ph. Eur.) Commission adopts new monographs and makes a number of revisions
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