Latest News in the pharma Industry

Policy & Regulation

Pfizer Announces EMA Acceptance of Regulatory Submissions for Cancer Therapies

Pfizer Announces EMA Acceptance of Regulatory Submissions for Cancer Therapies

18 Aug 2011

The EMA has accepted Pfizer's regulatory submissions for review of two investigational compounds, crizotinib and bosutinib.

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Nutra Pharma Receives Approval in India for Nyloxin

Nutra Pharma Receives Approval in India for Nyloxin

17 Aug 2011

Following the approval, the firm has accepted orders for the products through their distributor, Nutritional Alliance, for export to India-based importers.

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Pfizer Wins Viagra Patent Infringement Case Against Teva

Pfizer Wins Viagra Patent Infringement Case Against Teva

16 Aug 2011

Pfizer has won a patent infringement case that prevents Teva from marketing a generic version of Viagra.

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U.S. Government & Generic Industry Reach Deal on User Fees

U.S. Government & Generic Industry Reach Deal on User Fees

16 Aug 2011

Not everyone has seen user fees as a good idea, with critics raising questions about the idea of the FDA receiving funding from the very companies it's regulating.

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FDA to Establish Center for Regulatory Science

FDA to Establish Center for Regulatory Science

15 Aug 2011

The joint center will be established for joint research, educational training, collaborations and outreach in support of the FDA's mission to protect and promote public health.

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Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis

Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis

12 Aug 2011

Avanir Pharmaceuticals said it filed lawsuits against Par Pharmaceutical and Actavis, alleging infringement of patents related to its involuntary-emotion drug.

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FDA Approves Gilead's HIV Drug Complera

FDA Approves Gilead's HIV Drug Complera

11 Aug 2011

The approval of Complera is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies.

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Kamada Gets ODD from FDA for Type 1 Diabetes Treatment

Kamada Gets ODD from FDA for Type 1 Diabetes Treatment

11 Aug 2011

FDA grants an orphan drug designation for Kamada's Alpha-1 Antitrypsin drug to treat type 1 diabetes.

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Ironwood and Forest Submit New Drug Application for Linaclotide

Ironwood and Forest Submit New Drug Application for Linaclotide

10 Aug 2011

The submission includes efficacy and safety data from a Phase 3 program comprising four double-blind placebo-controlled trials and two open-label long term safety studies.

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FDA Accepts NDA for Allergic Rhinitis Treatment

FDA Accepts NDA for Allergic Rhinitis Treatment

9 Aug 2011

The FDA has accepted for filing Teva's New Drug Application for a nasal aerosol corticosteroid in development for the treatment of allergic rhinitis.

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European Commission Approves Boehringer's Oral Anticoagulant Pradaxa

European Commission Approves Boehringer's Oral Anticoagulant Pradaxa

9 Aug 2011

Regulators in Europe have given approval to Boehringer Ingelheim's oral anticoagulant Pradaxa for stroke prevention.

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FDA Nods for Orphan Drug Status of Merrimack MM-398

FDA Nods for Orphan Drug Status of Merrimack MM-398

9 Aug 2011

Merrimack Pharmaceuticals' pancreatic cancer drug has received orphan drug status approved by the FDA.

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