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Process & Production

Seattle Genetics gets FDA priority review for Adcetris in Cutaneous T-Cell Lymphoma Seattle Genetics reported that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
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H3 Biomedicine gets FDAorphan drug status for acute myelogenous leukemia treatment The US Food and Drug Administration (FDA) has granted orphan drug designation for H3 Biomedicine's H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML).
Production & Manufacturing > Process & Production > News Gilead gets FDA priority review for bictegravir regimen for HIV treatment The US Food and Drug Administration (FDA) has granted priority review for Gilead Sciences’ New Drug Application (NDA) for its investigational, fixed-dose combination of bictegravir (50mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection.
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InDex secures FDA orphan-drug designation for cobitolimod
InDex Pharmaceuticals has secured the orphan-drug designation for the drug candidate cobitolimod from the US Food and Drug Administration (FDA) for treatment of ulcerative colitis in pediatric patients.
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Genentech gets FDA priority review for Zelboraf in Erdheim-Chester Disease
The US Food and Drug Administration (FDA) has accepted Genentech's supplemental New Drug Application (sNDA) and granted Priority Review for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation.
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Janssen’s RA drug sirukumab fails to get FDA Advisory Committee nod
By PBR Staff Writer
Janssen Biotech has received a setback for its rheumatoid arthritis (RA) drug sirukumab after the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) decided not to recommend its approval.
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AstraZeneca's Acalabrutinib gets priority review from FDA for mantle cell lymphoma
AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for its Bruton tyrosine kinase (BTK) inhibitor, acalabrutinib.
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UK’s NICE invites Roche to submit CDF proposal for urothelial cancer drug
By PBR Staff Writer
The National Institute for Health and Care Excellence (NICE) has turned down Roche’s urothelial cancer drug atezolizumab citing the need for stronger evidence in clinical and cost effectiveness.
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Amgen, Allergan submit BLA to FDA for biosimilar candidate to Herceptin
Amgen and Allergan have submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
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Galera gets Promising Innovative Medicines Designation for GC4419 in UK
Galera Therapeutics' GC4419 has secured a Promising Innovative Medicines (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the reduction of the duration or incidence of radiation and chemotherapy induced severe oral mucositis in head and neck cancer patients.
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Kite Pharma seeks European approval for Axicabtagene Ciloleucel
Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are not eligible for autologous stem cell transplant.
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Eagle gets complete response letter from FDA on exertional heat stroke drug RYANODEX
Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
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CHMP issues positive opinion for Daiichi Sankyo's LIXIANA label update
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
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