Sandoz will provide "a limited number of scholarships" to patients who meet financial need criteria. Clozaril (clozapine) was recently launched as a therapy of last resort for refractory schizophrenic patients. Because of the risk of agranulocytis associated with use of the drug, patient white cell counts must be continually monitored. The drug is available only through the firm's "Patient Monitoring System" ("The Pink Sheet" Jan. 8, T&G-2). The assistance program is the inaugural program of the National Alliance for the Mentally Ill Assistance Corporation.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion
Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
