Supply shortages of Premarin (conjugated estrogens) may occur in one or more dosage strengths, American Home Products said in its Aug. 14 10-Q filing. On Aug. 8, Wyeth-Ayerst recalled two lots totaling more than 10 mil. tablets of the 1.25 mg strength. The recall is the sixth for dissolution failure since October (1"The Pink Sheet" Dec. 11, 2000, In Brief). Wyeth and FDA are discussing problems associated with failure to meet dissolution standards
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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.’
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
