Clinical

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.

While big pharma pours billions into creating new anti-aging molecules, a Belgian startup has taken a different path: combining existing safe drugs with AI precision. The early results suggest it might be onto something revolutionary.

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.