Latest News in the pharma Industry

Policy & Regulation

Sanofi NDA for lixisenatide accepted for review by FDA

Sanofi NDA for lixisenatide accepted for review by FDA

30 Sep 2015

First New Drug Application for a GLP-1 receptor agonist to include CV outcomes data.

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Lilly and Sanofi reach settlement agreement in US insulin glargine litigation

Lilly and Sanofi reach settlement agreement in US insulin glargine litigation

28 Sep 2015

Pending final FDA approval, Basaglar can be launched in the US beginning on 15 December 2016.

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Novo Nordisk receives US FDA approval for Tresiba and Ryzodeg 70/30

Novo Nordisk receives US FDA approval for Tresiba and Ryzodeg 70/30

28 Sep 2015

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Allergan launches generic version of Invega

Allergan launches generic version of Invega

25 Sep 2015

Allergan is the first company to receive FDA approval for and launch a generic version of Janssen's Invega.

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Pfizer’s Sayana Press becomes first injectable contraceptive in the UK available for administration by self-injection

Pfizer’s Sayana Press becomes first injectable contraceptive in the UK available for administration by self-injection

24 Sep 2015

Builds on current momentum towards broadening access to this contraceptive option for women across the globe.

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Munich Re and Marsh launch innovative NDBI cover for US life science companies

Munich Re and Marsh launch innovative NDBI cover for US life science companies

24 Sep 2015

The new non-damage business interruption insurance NDBI Pharma IQ combines risk transfer and consulting services to assist life sciences companies in managing the impact of regulatory actions imposed by the FDA.

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Taiho Oncology announces FDA approval of Lonsurf for refractory metastatic colorectal cancer

Taiho Oncology announces FDA approval of Lonsurf for refractory metastatic colorectal cancer

23 Sep 2015

Lonsurf represents the first FDA-approved product for Taiho Oncology, setting the stage for the company’s oncology pipeline.

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Swissmedic approves Novartis' new heart failure medicine Entresto

Swissmedic approves Novartis' new heart failure medicine Entresto

22 Sep 2015

Decision by Swiss Health Authority follows FDA approval of Entresto in July, and serves as an important reference approval for multiple other health authorities.

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FDA approves new drug to treat schizophrenia and bipolar disorder

FDA approves new drug to treat schizophrenia and bipolar disorder

22 Sep 2015

Vraylar is an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.

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Allergan confirms generic Rytary patent challenge

Allergan confirms generic Rytary patent challenge

21 Sep 2015

Allergan's ANDA product is a generic version of Impax Laboratories' Rytary.

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Impax receives FDA approval for generic version of Mestinon Timespan Tablets,     180 mg

Impax receives FDA approval for generic version of Mestinon Timespan Tablets, 180 mg

17 Sep 2015

First generic product approved from Hayward manufacturing facility following recent resolution of Warning Letter

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FDA establishes public docket to receive comments on enhancing the utility and usability of the inactive ingredient database

FDA establishes public docket to receive comments on enhancing the utility and usability of the inactive ingredient database

16 Sep 2015

FDA has announced the establishment of a public docket to receive comments from interested parties on enhancing the utility and usability of the Inactive Ingredient Database (IID) (also known as the Inactive Ingredient Guide). These comments will help ...

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