Thursday, June 13, 2019
FDA names companies to build blockchain network for drug supply
The FDA has selected IBM (NYSE:IBM), KPMG International, Merck (NYSE:MRK) and Walmart (NYSE:WMT) for a program to support the U.S. Drug Supply Chain Security Act (DSCSA).
The aim is to develop an electronic interoperable blockchain system enabling the real-time monitoring of products for drug supply chain stakeholders.
The pilot should be completed in Q4. The results will be published in the FDA DSCSA program report. Next steps will be evaluated at that time.
Roche’s Rituxan successful in late-stage pemphigus vulgaris study
A Phase 3 clinical trial, PEMPHIX, evaluating Roche’s (OTCQX:RHHBY) Rituxan (rituximab) compared to CellCept (mycophenolate mofetil)(MMF) in adults with moderate-to severe-pemphigus vulgaris (PV) met the primary endpoint, demonstrating that Rituxan was superior to MMF in achieving sustained complete remission.
The primary endpoint was the percentage of patients achieving sustained complete remission off corticosteroid therapy (no disease activity without the use of steroids for at least 16 consecutive weeks) at week 52.
Pemphigus vulgaris is an autoimmune disorder characterized by painful blistering skin.
The FDA approved Rituxan for the indication in June 2018.
Mallinckrodt’s Acthar Gel successful in Phase 4 rheumatoid arthritis study
A Phase 4 clinical trial evaluating Mallinckrodt’s (NYSE:MNK) Acthar Gel (repository corticotropin injection) in patients with patients with persistently active rheumatoid arthritis (RA) who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids met all primary and secondary endpoints. The results were presented at EULAR in Madrid.
62% of patients receiving Acthar Gel experienced sustained low disease activity (LDA) compared to 43% for placebo at week 24 as measured by a scale called DAS28-ESR. 86% of treated patients showed LDA at week 24 versus 66% for placebo as measured by another scale called CDAI.
The proportion of treated patients who achieved ACR70 (70% improvement in RA symptoms) at week 24 was 47% versus 42% for placebo. The proportions achieving ACR50 and ACR20 were 75% and 91%, respectively, compared to 70% and 84%, respectively, for placebo.
No new safety signals were observed.
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