Latest News in the pharma Industry

Policy & Regulation

FDA Requests More Data of Novartis Gout Drug

FDA Requests More Data of Novartis Gout Drug

31 Aug 2011

The FDA requested additional information surrounding canakinumab including clinical data to evaluate the benefit-risk profile in refractory patients.

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FDA Approves Pfizer's Lung Cancer Therapy

FDA Approves Pfizer's Lung Cancer Therapy

30 Aug 2011

Pfizer announced that it received US approval for its lung cancer drug Xalkori.

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FDA Gives Market Nod to J&J Pain Drug

FDA Gives Market Nod to J&J Pain Drug

29 Aug 2011

The approval follows J&J's study showing the safety and efficacy of the drug in Phase III studies.

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FDA Gives Fast-track Status to Algeta's Prostate Cancer Treatment

FDA Gives Fast-track Status to Algeta's Prostate Cancer Treatment

29 Aug 2011

Algeta's radium-223 chloride has been granted fast-track designation by the FDA for the treatment of castration-resistant prostate cancer in patients with bone metastases.

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Linagliptin Receives Approval in Europe to Treat Type 2 Diabetes

Linagliptin Receives Approval in Europe to Treat Type 2 Diabetes

29 Aug 2011

The approval of linagliptin in Europe was based on a clinical trial program which involved approximately 6,000 adults with type 2 diabetes.

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Hepatitis C Drug PSI-938 Granted FDA Fast-track Designation

Hepatitis C Drug PSI-938 Granted FDA Fast-track Designation

29 Aug 2011

Fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition.

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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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