Latest News in the pharma Industry

Policy & Regulation

District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda

District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda

18 Sep 2016

Shire to consider appeal.

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Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU

Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU

18 Sep 2016

Glyxambi is a single tablet that combines Jardiance and Trajenta and has been shown to improve blood sugar control in adults with type 2 diabetes.

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FDA advisory committees recommend to remove boxed warning in labeling for Pfizer’s smoking cessation therapy, Chantix

FDA advisory committees recommend to remove boxed warning in labeling for Pfizer’s smoking cessation therapy, Chantix

15 Sep 2016

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Santalis Pharmaceuticals issued patent for the use of sandalwood oil to treat cancers

Santalis Pharmaceuticals issued patent for the use of sandalwood oil to treat cancers

12 Sep 2016

Patent covers East Indian sandalwood oil-containing compositions that can be used to treat a variety of cancers.

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Dechra receives FDA approval for first US generic entrant antibiotic

Dechra receives FDA approval for first US generic entrant antibiotic

11 Sep 2016

Is the first registration Dechra has achieved through Putney's development pipeline since it acquired the US-based business

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Orphan Drug Designation granted to nintedanib for treatment of systemic sclerosis

Orphan Drug Designation granted to nintedanib for treatment of systemic sclerosis

9 Sep 2016

Designation also includes the associated interstitial lung disease.

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Lilly and AstraZeneca receive FDA Fast Track designation for AZD3293

Lilly and AstraZeneca receive FDA Fast Track designation for AZD3293

22 Aug 2016

AZD3293 is an investigational treatment for early Alzheimer's disease

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FDA pproves Pfizer's Troxyca ER Capsules CII with abuse-deterrent properties for the management of pain

FDA pproves Pfizer's Troxyca ER Capsules CII with abuse-deterrent properties for the management of pain

21 Aug 2016

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Indian FDA approves Innovus Pharma's Zestra, Zestra Glide, EjectDelay and Sensum+

Indian FDA approves Innovus Pharma's Zestra, Zestra Glide, EjectDelay and Sensum+

21 Aug 2016

Products now approved in seven countries.

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Portola Pharmaceuticals announces validation of MAA by EMA for IndexXa a Factor Xa inhibitoraAntidote

Portola Pharmaceuticals announces validation of MAA by EMA for IndexXa a Factor Xa inhibitoraAntidote

21 Aug 2016

EMA's CHMP to begin centralized review procedure.

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Portola Pharmaceuticals receives CRL for BLA for AndexXa

Portola Pharmaceuticals receives CRL for BLA for AndexXa

18 Aug 2016

Agency request additional information primarily related to manufacturing.

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FDA issues import alert for all drugs produced by Laxachem Organics in India

FDA issues import alert for all drugs produced by Laxachem Organics in India

17 Aug 2016

Decision taken after company refuses to allow FDA facility inspection.

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