Shots: Molecular to receive $50M upfront, $497M milestone and royalties on sales and also has certain rights to commercialize DARPin based products with MP0310. Amgen to get exclusive worldwide development and commercialization rights […]readmore
Tags : Amgen
Shots: The approval is based on P-III & P-I/II study results assessing Nplate vs PBO in pediatric patients with Immune Thrombocytopenia (ITP) for at least six months who had no response to corticosteroids, […]readmore
Shots: The OSLER-1 (Open-Label Study of Long-TERm Evaluation Against LDL-C) study involves assessing of Repatha (420 mg) + SoC or SoC alone in patients with hypercholesterolemia in ratio (2:1) across 192 sites […]readmore
Shots: Amgen to make $20M investment in Provention and also has option to license AMG-714 (after completion of P-IIb), if exercised will pay $150M as upfront plus milestones and royalties […]readmore
Biosimilars
Biotech
Amgen Collaborates with Orion for Commercialization of Amgevita (adalimumab, biosimilar)
Shots: Amgevita is indicated to treat chronic inflammatory diseases such as moderate-to-severe RA, IBD and psoriasis Amgen Biosimilar Amgevita, is a novel adalimumab’s biosimilar to be marketed in Finland. On […]readmore
Shots: The P-III MEASURE 1 and FUTURE 1 study involves assessing of Cosentyx (secukinumab) 75/ 150 mg vs PBO @16 wks. or 24 wks. in patients with PsA and AS […]readmore
Shots: Amgevita will be launched in 28 EU countries as well as Norway, Iceland and Liechtenstein making it 3rd EU Amgen’s approved biosimilar EMA approved Amgevita in RA, PsA, AS, […]readmore
Shots: The approval is based on P-IIIb LIBERTY (NCT03096834) study results assessing Aimovig (140mg) vs PBO for duration of 12 weeks The study resulted in 50% reduction of monthly migraine […]readmore
Biosimilars
Regulatory
Amgen and Allergan’s ABP 980 (biosimilar, Herceptin) Receives CHMP Recommendation
Shots: The CHMP recommendation is based on P-III study results assessing ABP 980 in adult female patients with HER2-positive early breast cancer The P-III study resulted in analytical, PK, pharmacology, […]readmore