Treatment options for psoriasis have expanded considerably, from conventional systemic therapies to biologic medicines, biosimilars and newer targeted treatments. However, the availability of an authorised medicine does not necessarily mean that every patient can …

Introduction If you asked us (and many other industrial consultants) what one of the most common commercial strategy mistakes we see in otherwise well-positioned early-stage companies is, without a doubt, it would be the …

Earlier this year the FDA has introduced significant regulatory changes for Laboratory Developed Tests (LDTs) to enhance their oversight and ensure higher standards of safety and effectiveness. These changes align LDTs with the regulatory …

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices (shortened to IVDs here for simplicity). IVDR officially entered into force on 25th May 2017, …