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ViiV Healthcare Presents Phase I Data for Ultra-Long-Acting Cabotegravir in HIV Treatment and Prevention
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GlaxoSmithKline (GSK; NYSE: GSK) unit ViiV Healthcare has presented Phase I results for an ultra-long-acting formulation of the antiretroviral cabotegravir, which is being investigated for the treatment and prevention of HIV. The safety and pharmacokinetic data from the study support the potential to double dosing intervals to four months or…
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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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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…
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BMS’s Subcutaneous Opdivo Meets Phase III Study Endpoints in ccRCC
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for…
