Latest News in the pharma Industry
Policy & Regulation
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
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
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
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
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
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
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
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
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
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
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
18 Aug 2011
The EMA has accepted Pfizer's regulatory submissions for review of two investigational compounds, crizotinib and bosutinib.
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