Latest News in the pharma Industry

Policy & Regulation

FDA Approves Opsumit to Treat Pulmonary Arterial Hypertension?

FDA Approves Opsumit to Treat Pulmonary Arterial Hypertension?

22 Oct 2013

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Ganymed’s IMAB362 Receives Orphan Drug Designation from FDA and EMA for Pancreatic Cancer

Ganymed’s IMAB362 Receives Orphan Drug Designation from FDA and EMA for Pancreatic Cancer

21 Oct 2013

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MannKind Resubmits New Drug Application to FDA for AFREZZA for the Treatment of Adults with Diabetes

MannKind Resubmits New Drug Application to FDA for AFREZZA for the Treatment of Adults with Diabetes

18 Oct 2013

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The ECA and the PQG Publish Two Draft Chapters on GDP Interpretation

The ECA and the PQG Publish Two Draft Chapters on GDP Interpretation

17 Oct 2013

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Fujifilm Diosynth Biotechnologies’ UK Site  Receives Renewed MHRA Manufacturing Licence

Fujifilm Diosynth Biotechnologies’ UK Site Receives Renewed MHRA Manufacturing Licence

9 Oct 2013

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Another Successful FDA Inspection at a Hovione Site

Another Successful FDA Inspection at a Hovione Site

7 Oct 2013

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Mark Copley Focuses on Bioequivalence Testing for Generics at 6th IPA Symposium

Mark Copley Focuses on Bioequivalence Testing for Generics at 6th IPA Symposium

26 Sep 2013

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Approval of Ultibro Inhalation Capsules in Japan

Approval of Ultibro Inhalation Capsules in Japan

20 Sep 2013

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WHO Publishes Revised Draft on GTDP for Pharmaceutical Starting Material

WHO Publishes Revised Draft on GTDP for Pharmaceutical Starting Material

19 Sep 2013

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FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers

FDA Approves First Generic Capecitabine to Treat Colorectal and Breast Cancers

18 Sep 2013

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FDA Prohibits Manufacture of FDA-Regulated Drugs from Ranbaxy’s Mohali, India, Plant and Issues Import Alert

FDA Prohibits Manufacture of FDA-Regulated Drugs from Ranbaxy’s Mohali, India, Plant and Issues Import Alert

17 Sep 2013

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FDA Draft Guidance - Specification of Unique Facility Identifier System for Drug Establishment Registration

FDA Draft Guidance - Specification of Unique Facility Identifier System for Drug Establishment Registration

13 Sep 2013

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