GlaxoSmithKline's February recall involving the two drugs did not encompass all affected lots, FDA says in announcing seizure of all doses and lots of the products. The action follows two "Form 483" reports in the last two years for GSK's Cidra, Puerto Rico facility, where the antidepressant and antidiabetic drugs are manufactured.
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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.’
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.
Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.
