Radio broadcast ads for Gaucher's disease therapy Cerezyme (imiglucerase) do not fulfill "adequate provision" requirement by directing consumers to a print ad, the Internet or their physician for additional information, FDA tells Genzyme in July 13 letter. The ad also "misleadingly minimizes the material fact that this drug is injected into the bloodstream over the course of one to two hours, and does not adequately explain that the patient may experience a variety of local reactions at the site of the injection (e.g., discomfort, itching, burning, swelling, or sterile abscesses)," FDA said. Cerezyme is an unusual choice for a direct-to-consumer campaign, given the extremely small Gaucher's disease population
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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.’
Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
