M834 (abatacept biosimilar) / Viatris - LARVOL DELTA

How To Prevent GVHD in Allogenic HSCT? - "In the latest episode of Blood Cancer Talks, Shernan Holtan, MD...for a conversation on graft versus host disease (GVHD) prophylaxis in allogenic hematopoietic stem cell transplantation (HSCT). Dr. Holtan and the hosts explored recent data on post-transplant cyclophosphamide and abatacept, including the BMT CTN 1203 trial. This trial studied three prophylaxis regimens (tacrolimus, mycophenolate mofetil, and cyclophosphamide; tacrolimus, methotrexate, and bortezomib; or tacrolimus, methotrexate, and maraviroc) versus tacrolimus and methotrexate for the prevention of GVHD with allogenic HSCT."

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🔥A practice-changing study was brought to my attention by @LCalabreseDO in a @HealioRheum article. I'll stop timing abatacept around the time of vaccines. @talkmedspoke

#COVID19 #vaccine boosters led to a significantly increased antibody response in patients using abatacept or TNF inhibitors regardless of whether they held medication, said @RADoctor @UABNews Read more 👇

Momenta and Mylan initiate phase 1 clinical trial for M834, a proposed biosimilar of Orencia (abatacept) (J&J Press Release) - P1, N=300; NCT02923583; Sponsor: Momenta & Mylan; "Momenta Pharmaceuticals and Mylan N.V., today announced that dosing has begun in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834...Momenta has achieved the milestone necessary to earn a $25 million payment from Mylan...The Phase 1 study...is expected to enroll approximately 300 healthy volunteers. The companies plan to report top-line data from this study by the end of 2017."

Anticipated P1 data • Anticipated target enrollment • Financing • New P1 trial • Ankylosing Spondylitis • Biosimilar • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Momenta Pharma: Q3 2016 Results (J&J) - Anticipated launch for psoriasis in 2020

Anticipated biosimilar launch • Psoriasis

Momenta Pharma: J. P. Morgan Healthcare Conference (35th Annual J.P. Morgan Healthcare Conference, J&J) - Anticipated initiation of P3 trial in psoriasis in H2 2017

Anticipated new P3 trial • Psoriasis

Momenta Pharma: J. P. Morgan Healthcare Conference (35th Annual J.P. Morgan Healthcare Conference, J&J) - Anticipated initiation of P3 trial in psoriasis in H2 2017

Anticipated new P3 trial • Psoriasis

Momenta provides year-end 2016 corporate update (J&J Press Release) - "M834...Momenta and Mylan initiated a Phase 1 trial in November 2016 and patient accrual is currently ongoing...plan to report top-line data from the Phase 1 trial in the second half of 2017."

Anticipated P1 data • Inflammatory Bowel Disease • Rheumatoid Arthritis

Momenta Pharmaceuticals reports second quarter 2013 financial results (Momenta Press Release) - "Momenta continues to advance toward achievement of defined milestones in 2014 for...M923 and M834 — two products targeting autoimmune and inflammatory indications...The milestones are achievement of technical development criteria and the first submission of an Investigational New Drug (IND) application in 2014 for its lead biosimilar M923..."

Anticipated IND • New molecule • Ankylosing Spondylitis • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Momenta and Mylan initiate early-stage study for proposed biosimilar of Orencia (Reuters) - "Momenta and mylan initiate phase 1 clinical trial for m834, a proposed biosimilar of orencia (abatacept)..."

Trial initiation date • Rheumatoid Arthritis