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Belgium

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Italy’s Responsible Person Sanctions Approach Raises Eyebrows

Fines are a fact of life when it comes to manufacturers’ compliance with EU rules on persons responsible for regulatory compliance. But Italy’s stance adds pressure on individuals appointed to the role.

Belgium Slashes Clinical Trial Review Times In Push To Draw More Studies

Deadlines for reviewing applications for mononational trials in Belgium will be cut by 50%.

How Controlling For Patient Psychology Can Reshape CNS Clinical Trial Success

Controlling for personality traits in clinical studies can deliver significant improvements in trial precision, with implications particularly relevant for CNS drug development

Clinical Trial Ethics Reviews Risk Becoming ‘Compliance Audits,’ Belgian Study Warns

Can ethics committees standardize consent without sacrificing ethical depth? A Belgian study urges balance between efficiency and meaningful dialog.

Attractiveness of Cell Therapy In The Spotlight With Limited Interest In Galapagos Unit

Non-binding offers have come mostly from groups of financial investors rather than biopharma players.

EADV: UCB’s Bimzelx Primed To Maintain Pole Position in HS

The Belgium-based group has collected heaps of long-term efficacy and safety data which will help stave off the competition.

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.

Hyloris Strikes New Deals With AFT And QliniQ Over Novel Valacyclovir Formulation

The Belgian value-added medicines specialist company struck two commercialization deals over its novel valacyclovir oral suspension that span three continents, marking a further milestone in the product’s development.

Hyloris Closes A Dramatic 2024 With A Move Towards Profit

After announcing updates in its ongoing legal battle and a leadership shakeup earlier this fiscal year, Hyloris closed 2024 with a slight rise in revenue and a shrinking of its reported net loss.

Belgian Body Hits Out At Roche For Delaying Biosimilar Competition

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

Belgian Body Hits Out At Roche For Delaying Biosimilar Competition

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”