Latest News in the pharma Industry

Policy & Regulation

FDA Grants Roche's Pertuzumab Priority Review

FDA Grants Roche's Pertuzumab Priority Review

14 Feb 2012

Roche announced that the FDA has accepted the company's Biologics License Application for pertuzumab and granted Priority Review.

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FDA Approves Shire's ADHD Drug Vyvanse for Maintenance Therapy in Adults

FDA Approves Shire's ADHD Drug Vyvanse for Maintenance Therapy in Adults

9 Feb 2012

The drug is Shire’s top-selling pharmaceutical, achieving sales of $199.7 million in the three months to September 30 2011, up 32% on the same period in 2010.

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Sanofi Acquires FDA Approval of Sklice Lotion to Treat Head Lice

Sanofi Acquires FDA Approval of Sklice Lotion to Treat Head Lice

8 Feb 2012

The FDA has approved Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older.

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Galvus Approved in EU as Monotherapy

Galvus Approved in EU as Monotherapy

7 Feb 2012

The European Commission has approved the use of Galvus in patients with type 2 diabetes unable to control their blood sugar with diet and exercise alone and who cannot take metformin.

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FDA Approves Merck's New Type 2 Diabetes Treatment

FDA Approves Merck's New Type 2 Diabetes Treatment

6 Feb 2012

The FDA has approved Merck's Janumet XR tablets, a new treatment for type 2 diabetes that combines sitagliptin with extended-release metformin.

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EMA Prepares to Introduce New Pharmacovigilance Legislation

EMA Prepares to Introduce New Pharmacovigilance Legislation

3 Feb 2012

The new pharmacovigilance legislation will significantly increase the transparency of all pharmacovigilance activities of the Agency and the European Member States.

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EMA Approves Orphan Medicinal Product Application of DCPrime’s AML Vaccine

EMA Approves Orphan Medicinal Product Application of DCPrime’s AML Vaccine

2 Feb 2012

The European Medicines Agency has issued a positive opinion recommending DCPrime’s application for orphan drug designation of dendritic cell-based cancer vaccine candidate.

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FDA Approves New Treatment for Skin Cancer

FDA Approves New Treatment for Skin Cancer

31 Jan 2012

Erivedge, reviewed under the agency's priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma.

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FDA Approves Jentadueto Tablets for Type 2 Diabetes

FDA Approves Jentadueto Tablets for Type 2 Diabetes

31 Jan 2012

FDA has approved Jentadueto tablets for patients who need to control their blood sugar.

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FDA Plans to Strengthen Warning Label on Lymphoma Drug Adcetris

FDA Plans to Strengthen Warning Label on Lymphoma Drug Adcetris

18 Jan 2012

The FDA is to strengthen the warning label on lymphoma drug Adcetris over concerns that it may be linked to brain infection.

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GSK Disagrees with Argentine Court Ruling over Vaccine Trials

GSK Disagrees with Argentine Court Ruling over Vaccine Trials

17 Jan 2012

GSK disagrees with the ruling and confirms the fine does not relate to the deaths of 14 children during the trial.

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FDA Completes Recommendations for Three Drug User Fee Programs

FDA Completes Recommendations for Three Drug User Fee Programs

16 Jan 2012

The programs include the fifth authorization of the Prescription Drug User Fee Act, and new user fee programs for human generic drugs and biosimilar biological products.

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