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Development of atacicept for lupus in patients with SLE is discontinued
A phase 2/3 trial of atacicept in combination with mycophenolate mofetil and corticosteroids for the treatment of lupus nephritis in patients with systemic lupus erythematosus has been discontinued.
In October 2008, Merck Serono announced that a phase 2/3 trial of atacicept in combination with mycophenolate mofetil and corticosteroids for the treatment of lupus nephritis in patients with systemic lupus erythematosus (SLE) was being discontinued because patients treated with this regimen experienced an increased risk of severe infection. The manufacturer stated that this increased risk of infection was probably the result of underlying disease activity and corticosteroid-induced immunosuppression. Trials of atacicept for generalized SLE, rheumatoid arthritis (RA), multiple sclerosis (MS), and hematologic malignancies are continuing as planned.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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