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Home » 2018 » November
EC approves Mundipharma’s Neulasta biosimilar Pelmeg for neutropenia

EC approves Mundipharma’s Neulasta biosimilar Pelmeg for neutropenia

Pelmeg EU approval : The European Commission (EC) has approved German pharma company Mundipharma’s Pelmeg, a pegylated version of granulocyte-colony stimulating factor (G-CSF) and also a biosimilar to Amgen’s neutropenia medication – Neulasta (pegfilgrastim). Pelmeg EU approval for Neutropenia The approval for Pelmeg is for its use as a treatment to bring down the duration […]

Spark Therapeutics bags Luxturna EU approval for inherited retinal disease

Luxturna EU approval for inherited retinal disease : Pennsylvania-based Spark Therapeutics has bagged the European Commission’s (EC) approval for its gene therapy Luxturna (voretigene neparvovec) to treat a rare inherited type of vision loss in both children and adults. Luxturna EU approval for inherited retinal disease Luxturna, an adeno-associated viral (AAV) vector gene therapy has […]

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Armas launches Azacitidine injection for myelodysplastic syndrome in US

Armas Pharmaceuticals has launched its first injectable to the US market in the form of Azacitidine for Injection 100 MG, a Vidaza generic, used for the treatment of myelodysplastic syndrome. A type of cancer, myelodysplastic syndrome leads to low count of one or more blood cell types. In May 2004, Vidaza, a nucleoside metabolic inhibitor […]

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Novartis’ Promacta bags FDA approval for first-line severe aplastic anemia

Promacta FDA approval : The US Food and Drug Administration (FDA) has approved a label expansion for Novartis’ Promacta (eltrombopag) to cover the treatment of severe aplastic anemia (SAA) in the first-line setting in combination with standard immunosuppressive therapy (IST). New Promacta FDA approval for first-line severe aplastic anemia The new Promacta FDA approval is […]

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IRX Therapeutics acquired by Brooklyn Immuno Therapeutics

Pharma acquisition news : Brooklyn Immuno Therapeutics, a newly formed pharma company focused on developing for cytokine-based therapies for cancers, has acquired the assets of IRX Therapeutics for an undisclosed price. The New York-based Brooklyn ImmunoTherapeutics, which is a clinical-stage biopharma company, is developing IRX-2, a novel cytokine-based therapy for the treatment of patients with […]

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Seattle Genetics’ Adcetris gets FDA approval for peripheral T-cell lymphoma

Adcetris FDA approval : Seattle Genetics has secured new approval from the US Food and Drug Administration (FDA) for its monoclonal antibody Adcetris (brentuximab vedotin), which is in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) for the treatment of certain types of peripheral T-cell lymphoma (PTCL). Adcetris FDA approval for PTCL in combination with CHP […]

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Cosmo Technologies bags Aemcolo FDA approval for travelers’ diarrhea

Aemcolo FDA approval : Cosmo Technologies has bagged approval from the US Food and Drug Administration (FDA) for its antibacterial drug Aemcolo (rifamycin) for the treatment of a type of travelers’ diarrhea. Aemcolo FDA approval The FDA approval for Aemcolo is for the treatment of adult patients with travelers’ diarrhea because of noninvasive strains of […]

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4DMT choroideremia therapy secures FDA orphan drug designation

4D Molecular Therapeutics (4DMT), a California-based gene therapy company, has secured orphan drug designation for 4D-110 from the US Food and Drug Administration (FDA) for the treatment of choroideremia (CHM), an X-linked monogenic recessive disease. Choroideremia, which results from the mutation of the REP-1 gene begins with reduced night vision and progressive loss of peripheral […]

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Calliditas initiates NEFIGARD trial to study Nefecon in Berger’s disease

Nefecon phase 3 trial : Calliditas Therapeutics has initiated a phase 3 clinical trial called NEFIGARD to evaluate its lead candidate Nefecon for the treatment of IgA nephropathy (IgAN), which is also known as Berger’s disease. Phase 3 NEFIGARD trial of Nefecon The Swedish pharma company has enrolled the first patient for the late-stage NEFIGARD […]

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Humacyte begins phase 2 Humacyl vascular trauma trial

Humacyl vascular trauma trial : Humacyte, a regenerative medical technology company, has started a phase 2 clinical trial of its investigational human acellular vessel (HAV) – Humacyl for vascular replacement or reconstruction in patients suffering from life- or limb-threatening vascular trauma. Humacyl is a bioengineered human acellular vessel which has been designed to significantly improve […]

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