herapeutic Goods Administration
Access The Vector Issue 3: 15 payers describe the likely affect of EU General Pharmaceutical Legislation on orphan drug strategy
In the third issue of The Vector, Genesis Research asked 15 payers across France, Germany, Italy, Spain, and the UK how they believe the new EU General Pharmaceutical Legislation will...
Alexion and Aide Health launch app for people with rare diseases
More than 3.5 million people in the UK live with a rare condition
Shionogi to acquire IntraBio in deal worth $2bn
The deal will expand Shionogi’s growing portfolio with IntraBio’s rare diseases capabilities
Ogsiveo recommended by NICE to treat rare soft tissue tumours
Desmoid tumours are rare soft tissue tumours that can grow aggressively into nearby tissues
Novartis’ Cosentyx gets positive CHMP opinion for polymyalgia rheumatica
If approved, this would be the first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica
LEO Pharma acquires rights for dersimelagon from Tanabe Pharma
The company will pay $435m in up front and near-term milestone payments
EMA recommends granting marketing authorisation approval for Nezglyal
The treatment is for cerebral adrenoleukodystrophy, a rare neurodegenerative disease
AstraZeneca’s Trixeo recommended by CHMP for approval in EU for asthma
Asthma affects over 360 million people worldwide, including over 40 million people in Europe
Almirall’s paediatric registration of Ebglyss for atopic dermatitis gets EMA acceptance
Atopic dermatitis affects a significant number of children and adolescents and often peaks in childhood
Regeneron’s New Drug Application for cemdisiran accepted for review by FDA and EMA
Globally, around 150 to 200 out of every million people have myasthenia gravis
EMA celebrates diversity and inclusion in science and healthcare
The EU body underlines its commitment to diverse perspectives in medicines regulation
LEO Pharma to acquire Replay gene therapy platform
The acquisition will advance innovation for patients with rare skin diseases