Latest News in the pharma Industry

Policy & Regulation

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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FDA and EMA accept regulatory applications for Boehringer Ingelheim's Gilotrif for treatment of advanced SCC of the lung

FDA and EMA accept regulatory applications for Boehringer Ingelheim's Gilotrif for treatment of advanced SCC of the lung

27 Aug 2015

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Rx-360 summary of WHO Annex 5 technical supplemets

Rx-360 summary of WHO Annex 5 technical supplemets

24 Aug 2015

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Mylan statement in response to FDA warning letter relating to certain Agila facilities

Mylan statement in response to FDA warning letter relating to certain Agila facilities

21 Aug 2015

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Rx-360 summary of FDA Final Guidance Refuse to Accept Policy for 510(k)s

Rx-360 summary of FDA Final Guidance Refuse to Accept Policy for 510(k)s

21 Aug 2015

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Novartis Drug Odomzo Gains EU Approval for Locally Advanced Basal Cell Carcinoma

Novartis Drug Odomzo Gains EU Approval for Locally Advanced Basal Cell Carcinoma

20 Aug 2015

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TGA Approves First mAb Biosimilar

TGA Approves First mAb Biosimilar

20 Aug 2015

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