Latest News in the pharma Industry

Policy & Regulation

FDA Warning Letter Says Sun Pharma Plant Hid Batch Failures

FDA Warning Letter Says Sun Pharma Plant Hid Batch Failures

21 May 2014

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FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Q&A

FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Q&A

20 May 2014

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US Marshals Seize Unapproved Drugs from Ohio Distributor

US Marshals Seize Unapproved Drugs from Ohio Distributor

20 May 2014

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Novartis Settles Patent Litigation on Gleevec (Imatinib Mesylate) with Sun Pharma Subsidiary

Novartis Settles Patent Litigation on Gleevec (Imatinib Mesylate) with Sun Pharma Subsidiary

15 May 2014

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Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma

Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma

15 May 2014

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Health Canada Confirms License Suspension of Biolyse Pharma for Serious Manufacturing Concerns

Health Canada Confirms License Suspension of Biolyse Pharma for Serious Manufacturing Concerns

14 May 2014

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NICE Issues Positive Recommendation for Xtandi  (Enzalutamide)

NICE Issues Positive Recommendation for Xtandi (Enzalutamide)

9 May 2014

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CDER SBIA Webinar on Postapproval Changes that may be Documented in Annual Reports

CDER SBIA Webinar on Postapproval Changes that may be Documented in Annual Reports

7 May 2014

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FDA Approves Epanova for the Treatment of Adults with Severe Hypertriglyceridaemia

FDA Approves Epanova for the Treatment of Adults with Severe Hypertriglyceridaemia

6 May 2014

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Epigenomics Updates on Regulatory Status for Epi proColon in the USA

Epigenomics Updates on Regulatory Status for Epi proColon in the USA

29 Apr 2014

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Lilly's Cyramza (Ramucirumab) Becomes First FDA-Approved Treatment for Advanced Gastric Cancer After Prior Chemotherapy

Lilly's Cyramza (Ramucirumab) Becomes First FDA-Approved Treatment for Advanced Gastric Cancer After Prior Chemotherapy

23 Apr 2014

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FDA Approves Merck’s Ragwitek (Short Ragweed Pollen Allergen Extract) Sublingual Tablet

FDA Approves Merck’s Ragwitek (Short Ragweed Pollen Allergen Extract) Sublingual Tablet

18 Apr 2014

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