The third approved cancer indication for Zeneca's Zoladex (goserelin acetate implant) is advanced breast cancer in pre- and perimenopausal women. FDA cleared the new indication NDA (20-515) on Dec. 18, concluding over eight years of clinical development by Zeneca on that indication. The product has previously approved indications for the treatment of advanced prostate cancer and endometriosis.
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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.’
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
