FDA’s Reproductive Health Products Advisory Committee meeting on Amgen’s osteoporosis drug could have derailed denosumab’s prospects at a number of key turning points. But Amgen’s presentation combined with the drug’s effi cacy profi le pushed the investigational product through a key regulatory toll gate relatively unscathed.
Ramsey Baghdadi
FDA's advisory committee meeting reviewing the marketability of Amgen Inc.'s osteoporosis drug denosumab (Prolia) was one of the most important...
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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 European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
