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MSD announced that it received a positive CHMP opinion for its anti-PD-1 therapy Keytruda® (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy in adjuvant treatment after surgery for adults with locally advanced, or e...

Biogen announced that it has withdrawn the MAA for aducanumab for the treatment of the early stages of Alzheimer’s disease, following feedback from the CHMP suggesting the data provided would not be sufficient to support a positive opinion.

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®.