Teva Pharma B.V.

Teva's Denosumab Biosimilar Candidate, TVB-009P, Accepted for Review by FDA and EMA

7 months ago

• Teva's TVB-009P, a biosimilar candidate to Prolia (denosumab), has been accepted for review by the FDA and validated by the EMA for treating osteoporosis. • The applications include all indications approved for Prolia, addressing conditions with a high risk of fracture, particularly in postmenopausal women. • TVB-009P is the first internally developed biosimilar from Teva submitted to the FDA, with decisions from both agencies expected in the second half of 2025.

GSK's Depemokimab Shows Promise in Reducing Severe Asthma Exacerbations

9 months ago

• Depemokimab significantly reduced severe asthma attacks by 54% compared to placebo in Phase 3 trials, offering a potential new treatment option. • The ultra-long-acting biologic showed a 72% reduction in exacerbations requiring hospitalization or emergency department visits, highlighting its clinical impact. • Administered just twice yearly, depemokimab could improve treatment adherence and provide sustained suppression of type 2 inflammation in severe asthma. • These findings, presented at the European Respiratory Society International Conference, support regulatory filings for depemokimab globally.