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136-150 of 46356 results
Mylan acquires non-US specialty, branded generics assets from Abbott
By PBR Staff Writer
US-based generic and specialty pharmaceuticals firm Mylan has completed the acquisition of Abbott Laboratories' non-US developed markets specialty and branded generics business.
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Actavis and Medicines360 get FDA approval for pregnancy prevention drug Liletta
By PBR Staff Writer
Irish pharmaceutical firm Actavis and Medicines360 have received approval from the US Food and Drug Administration (FDA) for Liletta (levonorgestrel-releasing intrauterine system) 52mg for use by women to prevent pregnancy for up to three years.
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FDA accepts Bristol-Myers' BLA for Opdivo to treat advanced squamous NSCLC
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb's biologics licensing application (BLA) for Opdivo (nivolumab) to treat patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy.
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Roche gets EMA positive recommendation for Avastin plus chemotherapy to treat cervical cancer
By PBR Staff Writer
Roche has received positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the use of Avastin (bevacizumab) in combination with standard chemotherapy to treat adults with persistent, recurrent or metastatic cervical cancer.
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EMA committee issues positive opinion for Novartis' lung cancer drug Zykadia
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for Novartis' Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
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Mundipharma introduces Remsima (infliximab) in six European countries
By PBR Staff Writer
Mundipharma International’s network of independent associated companies are set to introduce a new-generation value-based monoclonal antibody, Remsima (infliximab), this month in six European countries.
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Triphase, Sunnybrook to advance development new bi-specific antibody for cancer patients
By PBR Staff Writer
US-based Triphase Accelerator has entered into an academic center collaboration with Canada's Sunnybrook Research Institute to advance development of its new, first-in-class, fully human bi-specific antibody TRPH 011 and evaluate the role of bifunctional targeting of VEGFR-2 and TIE 2 receptors in cancer patients.
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Columbia to begin Phase II trial of lidocaine bioadhesive 10% gel
By PBR Staff Writer
US-based Columbia Laboratories (CBRX) is planning to start a Phase II clinical trial for COL-1077, a lidocaine bioadhesive 10% gel, in women undergoing transvaginal pipelle-directed endometrial biopsy.
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ObsEva releases positive results from Phase I trial of OBE001 to treat preterm labour
By PBR Staff Writer
Swiss biopharmaceutical firm ObsEva has reported positive results from a Phase I drug interaction trial of its new orally active oxytocin receptor antagonist, OBE001, designed to treat preterm labour.
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EMA grants orphan drug status for Tolero's leukemia drug alvocidib
By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan drug designation for Tolero Pharmaceuticals' alvocidib to treat patients with acute myeloid leukemia (AML).
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Portola's factor Xa inhibitor antidote andexanet alfa gets FDA orphan drug status
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Portola Pharmaceuticals' Factor Xa inhibitor antidote andexanet alfa, which reverses the anticoagulant effect of direct or indirect Factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent surgery.
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EMA accepts MAA for Amgen's myeloma drug Kyprolis
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) of Amgen and Onyx Pharmaceuticals' Kyprolis (carfilzomib) for Injection to treat patients with relapsed multiple myeloma who have received at least one prior therapy.
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Bayer's Eylea wins approval in Europe to treat retinal vein occlusion
By PBR Staff Writer
German pharmaceutical firm Bayer HealthCare has received approval from the European Commission for Eylea (aflibercept solution for injection into the eye) to treat patients with visual impairment due to macular edema secondary to retinal vein occlusion (RVO).
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Lupin enters into clinical research partnership with Acceliant
By PBR Staff Writer
India-based drugmaker Lupin has entered into partnership with Acceliant, a provider of advanced clinical trial data management solutions, to use its clinical trial platform for drug research programs.
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Amgen reports positive results from Phase III study of AMG 416 with cinacalcet
By PBR Staff Writer
Amgen has reported that the head-to-head Phase III study comparing AMG 416 with cinacalcet has met endpoints in the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.
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