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European Commission Approves Takeda’s Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy
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The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502) for its plasma-derived therapy Hyqvia (human immune globulin infusion 10% with recombinant human hyaluronidase) as a maintenance treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). This follows a similar indication extension for the subcutaneous drug in…
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Bristol Myers Squibb’s Subcutaneous Opdivo Shows Noninferiority in Phase III ccRCC Trial
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Bristol Myers Squibb (BMS; NYSE: BMY) this week announced preliminary Phase III data demonstrating that its subcutaneous formulation of Opdivo (nivolumab), developed in partnership with Halozyme Therapeutics (NASDAQ: HALO), is noninferior to the intravenous version for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The equivalence trial…
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Takeda’s Hyqvia Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
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Japanese pharmaceutical company Takeda (TYO: 4502) has received an indication extension approval from the US Food and Drug Administration (FDA) for its plasma-derived therapy Hyqvia (human immunoglobulin 10%). The therapy is now approved for use as a maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP). Initially approved in the US…
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Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
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Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
