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Process & Production

CHMP recommends GSK, Innoviva’s single inhaler triple therapy for COPD By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.
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FDA advisory panel recommends approval of GSK’s shingles vaccine Shingrix By PBR Staff Writer
An advisory committee of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline’s (GSK) Shingrix vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and over.
Production & Manufacturing > Process & Production > News Deciphera gets FDA orphan drug designation for DCC-2618 to treat glioblastoma multiforme and anaplastic astrocytoma Deciphera Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, for the treatment of glioblastoma multiforme and anaplastic astrocytoma.
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Bayer submits BLA to FDA for BAY94-9027 to treat Hemophilia A
By PBR Staff Writer
Bayer is seeking approval from the US Food and Drug Administration (FDA) for its its long-acting factor VIII, BAY94-9027, to treat Hemophilia A.
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Roche secures priority review from FDA for haemophilia A drug emicizumab
By PBR Staff Writer
Roche's emicizumab prophylaxis (preventative) has been granted priority review by the US Food and Drug Administration (FDA) for haemophilia A with factor VIII inhibitors.
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Epygenix gets FDA orphan drug status for EPX-300 to treat Dravet Syndrome
Epygenix Therapeutics has secured orphan drug status from the US Food and Drug Administration (FDA) for its EPX-300 to treat patients with Dravet Syndrome.
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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).
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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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