FDA's Fertility and Maternal Health Drugs Advisory Committee will meet June 19 to discuss the company's supplemental NDA, filed April 30, for the use of injectable medroxyprogesterone acetate suspension for contraception. Upjohn originally had filed for the contraceptive indication in 1967, but withdrew the application in 1986 in order to resubmit it with new safety data. The drug is indicated for adjunctive therapy and palliative treatment of inoperable, recurrent and metastatic endometrial carcinoma or renal carcinoma. The meeting begins at 9 a.m. in FDA's Parklawn Building in Rockville, Maryland.
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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.’
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.
The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.
