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Clinical

Future Proofing Gene Therapy Assays For Regulatory Success

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.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

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.

Podcast: Scancell’s Cancer Vaccine Progress With NHS Partnership

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.

Lilly’s Kisunla Label Update Lowers ARIA-E Risk For Alzheimer’s Patients

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.

Thinking Outside The BIOX: Bioxodes Takes Novel Approach To Intracerebral Hemorrhage

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.

This Belgian Biotech’s Drug Cocktail Could Help Reverse Muscle Aging

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.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

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.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

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.

Axoft Starts Commercializing Soft BCI-Enabling Materials For R&D Use, Aims To Rewrite BCI Playbook

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.

Sumitomo, Ex-Pfizer Exec On Lipitor Lessons, Lady Gaga Connect For Go-To-Market Strategy

CEO of Sumitomo Pharma America unit, Adele M. Gulfo, draws from experiences working across companies including Pfizer, to advise on go-to-market strategies for a portfolio across primary care to rare disease.