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Australia’s TGA granted orphan drug designation to Roche’s glofitamab.  The TGA also provided approval for Roche to apply for registration using the provisional approval pathway, an expedited approval process.  Roche has until 21 October 2022 to make an application through ...

Biogen reported that it has completed the sale of its stake in the Samsung Bioepis joint venture to Samsung Biologics.  In January 2022 Biogen announced that it would sell its stake in Samsung Bioepis for an aggregate consideration of up to USD $2.3 billion.

Amgen released preliminary results from its Ph III study of ABP654 (proposed ustekinumab biosimilar) in adults with severe plaque psoriasis.  Amgen reported that the study met the primary efficacy endpoint, and that the safety profile of ABP654 was comparable to STELARA®.

Cancer Network reported that initial data from AstraZeneca’s Ph II trial of durvalumab and tremelimumab in combination with chemotherapy as neoadjuvant therapy for patients with advanced-stage ovarian cancer was presented at the AACR meeting.  The results suggest that more ...

BIOJAMP announced the launch of SIMLANDI™/AVT02 (high-concentration, low volume, citrate-free biosimilar adalimumab) in Canada.  JAMP Pharma has exclusive commercialisation rights to Alvotech’s AVT02 in Canada in accordance with their January 2020 agreement.