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Home » 2018 » July
Hyrimoz EC approval : Novartis biosimilar of AbbVie Humira approved in EU

Hyrimoz EC approval : Novartis biosimilar of AbbVie Humira approved in EU

Hyrimoz EC approval : Novartis’ Sandoz has bagged approval for Hyrimoz (adalimumab), a biosimilar of AbbVie’s Humira (adalimumab), in Europe for all indications of the reference drug including rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis and ulcerative colitis. The approval of Hyrimoz by European Commission (EC) was driven by analytical, preclinical and clinical research that […]

CHMP recommends AstraZeneca lung cancer drug Imfinzi EMA approval

Update on Imfinzi EMA approval : The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the approval of AstraZeneca lung cancer drug Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The committee has recommended Imfinzi EMA approval of […]

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Cambrex to acquire US CDMO Halo Pharma for $425m

Cambrex has agreed to acquire Halo Pharma, a US CDMO (contract development and manufacturing organization), for $425 million to foray into the large and growing finished dosage form CDMO market. Also based in the US, Cambrex is a manufacturer of small molecules and generic Active Pharmaceutical Ingredients (APIs). It will be acquiring Halo Pharma from […]

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FDA approves Agios’ Tibsovo for acute myeloid leukemia treatment

Tibsovo (ivosidenib) developed by Agios Pharmaceuticals has been approved by the US Food and Drug Administration (FDA) for acute myeloid leukemia treatment in patients with a specific genetic mutation and whose condition relapsed or is refractory. The Agios AML drug has been indicated to be used with an FDA-approved companion diagnostic that will detect specific […]

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Nivestym FDA approval : Pfizer’s Amgen neutropenia drug Neupogen biosimilar gets FDA nod

Nivestym FDA approval : Pfizer has bagged approval from the US Food and Drug Administration (FDA) for Nivestym (filgrastim-aafi) – a biosimilar to Neupogen (filgrastim) for all eligible indications of the reference Amgen neutropenia drug. Filgrastim is indicated in the US for neutropenia treatment among others. Neutropenia or low blood neutrophils, is a condition in […]

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Dutch pharma company Norgine opens new offices in Germany

Dutch pharma company Norgine has opened new offices in its largest product sales market – Germany at Wettenberg as part of its continued investment to support its growth strategy. Norgine, which was established more than 110 years, acquires, develops, manufactures and commercializes products that address patients’ needs across specialist therapy areas. The areas of focus […]

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Ivosidenib FDA approval : Agios blood cancer drug approved for AML

Ivosidenib FDA approval : The US Food and Drug Administration (FDA) has approved Agios Pharmaceuticals’ blood cancer drug TIBSOVO (ivosidenib) for the treatment of acute myeloid leukemia (AML). The ivosidenib FDA approval is for the treatment of adult patients whose condition is relapsed or refractory and who are prone to isocitrate dehydrogenase-1 (IDH1) mutation as […]

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Novartis to in-license atopic dermatitis drug MOR106 from MorphoSys, Galapagos

Novartis has agreed to acquire the exclusive global development and marketing rights of atopic dermatitis drug MOR106 from MorphoSys and Galapagos in a deal that could go up to $1.1 billion. The Swiss drugmaker will make an upfront payment of €95 million ($111 million) to Galapagos and MorphoSys apart from potential milestone payments of up […]

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Vyriad, Merck to launch phase 1 study of immuno oncology drugs Voyager-V1 and avelumab

Vyriad, a US biotech company, has entered into a collaboration with Germany-based Merck to launch a phase 1 trial of their immuno oncology drugs combination of Voyager-V1 and Bavencio (avelumab), respectively, for metastatic colorectal cancer. According to Vyriad, Voyager-V1 is an oncolytic virotherapy which is a bullet-shaped, negative-sense RNA virus having low human seroprevalence. The […]

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FDA panel adopts positive opinion over GSK malaria drug tafenoquine

An advisory committee of the United States Food and Drug Administration (FDA) has endorsed GSK malaria drug tafenoquine to be used as a single-dose for the treatment and relapse prevention of Plasmodium vivax (P. vivax) malaria in patients, aged 16 years and more. The Antimicrobial Drugs Advisory Committee (AMDAC) of the FDA had voted unanimously […]

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