Latest News in the pharma Industry

Policy & Regulation

Health Canada OKs Hepatitis Drug Incivek

Health Canada OKs Hepatitis Drug Incivek

26 Aug 2011

Vertex Pharmaceuticals receives Health Canada approval for Incivek tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease.

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EMA: New Validation Criteria for Electronic Submissions into Effect Next Month

EMA: New Validation Criteria for Electronic Submissions into Effect Next Month

25 Aug 2011

According to EMA's note, new version of the validation criteria for electronic applications for human medicines will come into effect on 1 September.

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Skin Cancer Drug Yervoy Awarded European Licence

Skin Cancer Drug Yervoy Awarded European Licence

24 Aug 2011

Yervoy, the first advanced skin cancer drug since the 1970s, has been awarded a European licence.

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Health Canada Approves Treatment for Vision Loss

Health Canada Approves Treatment for Vision Loss

19 Aug 2011

Approximately 27,000 Canadians suffer from RVO every year making RVO the second-most common cause of vision loss due to retinal vascular disease after diabetic retinopathy.

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FDA Approves Skin Cancer Treatment Zelboraf

FDA Approves Skin Cancer Treatment Zelboraf

18 Aug 2011

Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival in patients with late-stage melanoma.

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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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