FDA priority review given to Bayer’s investigational blood cancer drug

Bayer announces that its investigational blood cancer treatment, copanlisib, has been awarded priority review designation from the FDA, thereby meaning the regulator pledges to review the product within a six-month timeframe. The blood cancer drug is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. It is indicated

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First Immunotherapy for High Risk Neuroblastoma approved for use in the EU

EU regulators have issued approval for the first immunotherapy for high-risk neuroblastoma, which will offer a new treatment option to thousands of children affected by the rare and devastating form of cancer. EUSA Pharma’s dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen (GD2) on neuroblastoma cells, now indicated to treat

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NICE U Turn leads to backing for Celgene’s Imnovid for multiple myeloma

NICE has backed Celgene’s multiple myeloma pill Imnovid in combination with dexamethasone for use on the NHS in new draft guidance. Imnovid has been given approval for the treatment of people with relapsed or refractory multiple myeloma that have already undergone three previous treatments, including Celgene’s Revlimid and Takeda’s Velcade. The U-turn by the UK

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Roche’s Cancer Immunotherapy Atezolizumab gains FDA Priority Review for Advanced Bladder Cancer

Roche Group announced today that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of

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