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Apotex Receives Health Canada Approval for Denoza (Biosimilars, Prolia) 

Shots:  Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia  Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph  Denoza will be available in a prefilled syringe format  Ref: Apotex | Image: Apotex | Press Release…

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Argenx

argenx Reports the US FDA’s Approval of Vyvgart Hytrulo Prefilled Syringe for gMG and CIDP

Shots: The US FDA has approved Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) prefilled syringe to treat AChR+ adults with generalized myasthenia gravis (gMG) & adults with chronic inflammatory demyelinating polyneuropathy (CIDP) Approval was based on studies showing bioequivalence to Vyvgart Hytrulo vial, with human factors validation confirming that pts with gMG or CIDP, or their caregivers,…

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Viewpoint_Ted Omachi_2020

PharmaShots Interview: Genentech’s Ted Omachi Shares Insights on Xolair (omalizumab) PFS

The US FDA has accepted the sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications. In an interview with PharmaShots, Ted Omachi the Global Development Leader for Xolair and Senior Medical Director of Product Development Immunology shares details and highlights of Xolair (omalizumab) PFS for self-administration. Shots: A decision on…

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