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Process & Production

Amgen gets CHMP positive ppinion for Repatha to treat high cholesterol Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Repatha (evolocumab) recommending approval for use in certain patients with high cholesterol.
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Bristol-Myers gets CHMP positive opinion for lung cancer drug nivolumab By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Bristol-Myers Squibb's nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval to treat locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Production & Manufacturing > Process & Production > News Aura Biosciences gets FDA orphan disease designation for AU-011 to treat uveal melanoma By PBR Staff Writer
US-based biotech firm Aura Biosciences received orphan disease designation from the US Food and Drug Administration (FDA) for its drug AU-011 for the treatment of Uveal Melanoma, also referred to as Ocular Melanoma (OM).
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Wockhardt gets FDA QIDP status for new pneumonia drug WCK 4873
By PBR Staff Writer
Indian drug-maker Wockhardt has received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) for one of its product, WCK 4873, for the treatment of pneumonia.
Production & Manufacturing > Process & Production > News
Baxter BioScience submits MAA in Europe for IGSC 20% to treat primary immunodeficiency
By PBR Staff Writer
Baxter BioScience has submitted a marketing authorization application (MAA) to 17 competent authorities in Europe following the decentralized procedure (DCP) for approval of its investigational 20% concentration subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies (PI).
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Aphios gets US patent for Alzheimer’s disease treatment
Aphios has announced that it was granted US Patent No. 9,034,347 directed to the treatment of neurodegenerative diseases such as Hutchinson Disease, Parkinson's disease, Down's syndrome and Alzheimer's disease.
Production & Manufacturing > Process & Production > News
Drum Massager
Custom Powder Systems makes a product called a drum massager. It has two sets of C-shaped arms that come in and compress the drum. There's a turntable that turns the drum, compresses it again. It raises up, does additional compressions, and cracks up, breaks up the material.
Production & Manufacturing > Process & Production > Products
Immunomedics gets FDA fast track status for lung cancer drug sacituzumab govitecan
By PBR Staff Writer
US-based biopharmaceutical firm Immunomedics has secured fast track designation from the US Food and Drug Administration (FDA) for its lead antibody-drug conjugate (ADC), sacituzumab govitecan, to treat patients with metastatic non-small cell lung cancer (NSCLC).
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Pernix's Treximet gets FDA approval to treat migraine in pediatric patients
By PBR Staff Writer
Pernix Therapeutics Holdings has received approval from the US Food and Drug Administration (FDA) for Treximet (sumatriptan and naproxen sodium) for use in pediatric patients aged 12 years and older to treat migraine with or without aura.
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Abbvie gets FDA orphan drug status for Humira to treat Hidradenitis Suppurativa
By PBR Staff Writer
AbbVie has received orphan drug designation from the US Food and Drug Administration (FDA) for Humira (adalimumab) to treat moderate-to-severe hidradenitis suppurativa (HS) (Hurley Stage II and Hurley Stage III disease).
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TissueGene enters SPA agreement with FDA for Phase III trial of Invossa to treat osteoarthritis of the knee
TissueGene has reached an agreement with the US Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design, endpoints and statistical analysis plan for a Phase 3 clinical trial for Invossa, an allogeneic cell therapy for osteoarthritis of the knee.
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GlycoMimetics' GMI-1271 gets FDA orphan drug status to treat AML
By PBR Staff Writer
GlycoMimetics has secured orphan drug designation from the US Food and Drug Administration (FDA) for GMI-1271, a new and proprietary E-selectin antagonist in the company’s pipeline to treat patients with acute myeloid leukemia (AML).
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LCS Group to commercialize '813 patent and '249 application for binge eating disorder
LCS Group has announced its exclusive license from Lucerne Biosciences to commercialize US Patent No. 8,318,813 and U.S. Patent Application No. 14/464,249, both titled "Method of Treating Binge Eating Disorder" ("BED").
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