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Process & Production

EMA accepts Sandoz application for biosimilar to Amgen's Neulasta cancer drug By PBR Staff Writer
The European Medicines Agency (EMA) has accepted an application to review Sandoz's biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim) cancer drug.
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Arch Biopartners submits AB569 orphan drug application to EMA Arch Biopartners has submitted an application for orphan drug designation to the European Medicines Authority (EMA) for AB569 in the treatment of Pseudomonas aeruginosa (P. aeruginosa) pulmonary infections in patients with cystic fibrosis.
Production & Manufacturing > Process & Production > News FDA issues complete response letter to Telesta's BLA for MCNA The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Telesta Therapeutics' Biologics License Application (BLA) for MCNA.
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EMA validates Gilead’s Type II variation application for Truvada
Gilead Sciences announced that its Type II variation application for once-daily Truvada (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis or PrEP, has been fully validated and is now under evaluation by the European Medicines Agency (EMA).
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CHMP adopts positive opinion recommending Empliciti to treat multiple myeloma
Bristol-Myers Squibb and AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Empliciti (elotuzumab), an investigational immunostimulatory antibody, be granted approval for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone in patients who have received at least one prior therapy.
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EMA recommends approval of Coagadex to treat rare bleeding disorder
By PBR Staff Writer
The European Medicines Agency (EMA) has recommended granting a marketing authorization for Coagadex to treat factor X deficiency, a rare inherited bleeding disorder.
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FDA to review Acadia's Nuplazid drug to treat Parkinson’s disease psychosis
By PBR Staff Writer
The US Food and Drug Administration's (FDA) psychopharmacologic drugs advisory committee will review data included in Acadia Pharmaceuticals' new drug application (NDA) for Nuplazid (pimavanserin) to treat psychosis associated with Parkinson’s disease.
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FDA to review Merck’s bezlotoxumab C. difficile antitoxin
By PBR Staff Writer
The US Food and Drug Administration (FDA) has agreed to review Merck’s biologics license application (BLA) for bezlotoxumab, an investigational antitoxin being developed to avoid recurring Clostridium difficile (C. difficile) infection.
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FDA completes Biofrontera's Ameluz NDA mid-cycle review
Biofrontera, a biopharmaceutical company focusing on sun-induced skin cancer, has announced recent progress on the ongoing approval process for Ameluz and BF-RhodoLED in the US.
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Virginia resident tests positive for mosquito-borne Zika virus
By PBR Staff Writer
A Virginia resident who traveled outside the US has tested positive for the mosquito-borne virus, Zika.
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FDA accepts BLA submission for brodalumab in moderate-to-severe plaque psoriasis
The US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis.
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XTL gets encouraging feedback from FDA on IND filing for lupus drug hCDR1
XTL Biopharmaceuticals has received written guidance from the US Food and Drug Administration (FDA) in response to a pre-investigational new drug (IND) meeting package regarding its upcoming IND filing for its drug candidate, hCDR1.
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Cleveland BioLabs' Entolimod wins orphan drug status from EMA as radiation countermeasure
Cleveland BioLabs announced that entolimod has been granted orphan drug status by the European Medicines Agency (EMA) for treatment of acute radiation syndrome.
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