17 Aug 21 | US | The USPTO Patent Trial and Appeal Board (PTAB) will review Amgen’s US 8,273,707 Patent (related to NEULASTA® (pegfilgrastim) in an IPR challenge brought by Pfizer and Hospira. The PTAB declined to deny institution in view of the pending litigation in the US District of Delaware.
17 Aug 21 | US | The FDA announced the Biosimilar User Fee Act rates for the 2022 fiscal year. The new rates will apply from 01 October 2021.
17 Aug 21 | Novartis announced the results of its Ph III trials of Beovu® (brolucizumab) versus aflibercept in patients with diabetic macular edema, reporting that Beovu demonstrated superiority versus aflibercept in key endpoints.
17 Aug 21 | CN | Novartis announced that China’s NMPA has expanded its approval of Cosentyx® (secukinumab) to include the treatment of plaque psoriasis in paediatric patients.
19 Aug 21 | AU | Australia’s TGA granted approval for AbbVie’s Skyrizi® (risankizumab) in a higher, 150mg/mL concentration formulation. Skyrizi is indicated for plaque psoriasis in adults.
20 Aug 21 | UK | The UK’s MHRA granted conditional marketing authorisation for REGEN-COV®/Ronapreve® (casirivimab and imdevimab antibody cocktail) to prevent and treat acute COVID-19 infection.