FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

RestorixHealth acquires CutisCare to expands wound care portfolio

Roche’s Gazyva shows strong phase III results for treatment of idiopathic nephrotic syndrome

Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva

Allergan Aesthetics and Girls inspire the next generation of women leaders in STEM

Allergan Aesthetics reaffirms commitment to empowering girls through STEM mentorship and education initiatives

Europe is putting vital medicines at risk by allowing ‘carbon heavy’ imports from the Far East: INEOS

INEOS production of BDO in Germany, which produces a vital ingredient for antibiotics, statins and vitamin B6, is being crushed by a flood of carbon heavy imports and product dumping from the Far East

Moderna discontinues congenital virus program after Phase 3 trial fails to meet primary endpoint

Vaccine efficacy against primary CMV infection ranged from 6 per cent to 23 per cent, depending on case definition, falling short of Moderna’s predefined target

ACG to invest $200 million in US hard-shell capsule manufacturing

The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study

Pfizer’s Braftovi+Mektovi shows sustained long-term survival in patients with advanced lung cancer

Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population

Johnson & Johnson’s Rybrevant shows 45% response rate in HNSCC

Based on these promising results, Johnson & Johnson plans to move the program into a Phase 3 trial to further investigate subcutaneous amivantamab