Clinical

The European Commission’s proposal does not envisage a single centralized medtech agency, but instead sets out a targeted redistribution of tasks that could strengthen the existing framework. Professor Tom Melvin told Medtech Insight how.

Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.

Sponsors of higher risk device and diagnostic investigations are being invited to participate in a pilot that aims to reduce regulatory burden.

To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.

Clinical evaluation and standards expert Danielle Giroud celebrates progress on the document and looks at what it means internationally and for the EU.

In this detailed overview, Generics Bulletin dives into which biosimilar sponsors are currently known to be working towards filings for biosimilars to Keytruda (pembrolizumab), which had sales of around $30bn last year.

Orexo believes its data further demonstrates the ability of the AmorphOX powder-based intranasal formulation technology to develop formulations for large molecules.

As gene therapy advances and regulations tighten, biopharma companies face growing pressure to design diagnostic assays that are both flexible and future ready. Strategic early investment in assay development can prevent costly delays and rework as therapies progress toward approval.

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

In the latest podcast interview, Phil L'Huillier, CEO of Scancell, discussed the company's work in cancer vaccine development, and its selection as the first British biotech to be a part of the NHS Cancer Vaccine Launch Pad.

The updated US FDA label modifies dose titration based on TRAILBLAZER-ALZ 6, a study that showed a more gradual rise in dosing levels reduced ARIA-E incidence without reducing amyloid clearance.

Although intracerebral hemorrhage accounts for only 13% of all strokes, it is responsible for approximately 40% of stroke-related deaths. A Belgian biotech is looking in unusual places to rectify this situation, namely in a tick’s mouth.