Latest News in the pharma Industry

Policy & Regulation

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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
GSK Fined over Vaccine Trials on Argentine Children

GSK Fined over Vaccine Trials on Argentine Children

13 Jan 2012

The firm was fined $93,000 by an Argentine court for failing to obtain parental consent to conduct the trials.

Read more 
FDA Accepts Arena's NDA Resubmission for Lorcaserin

FDA Accepts Arena's NDA Resubmission for Lorcaserin

11 Jan 2012

The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.

Read more 
US Draft Bill Submitted to Address Penalties of Drug Trafficking

US Draft Bill Submitted to Address Penalties of Drug Trafficking

10 Jan 2012

The Act imposes a fine of up to US$4m on individuals for a first offence and $8m for repeat offences, as well as a jail term of up to 20 years for each offence.

Read more 
FDA Expands Use of Prevnar 13 Vaccine

FDA Expands Use of Prevnar 13 Vaccine

4 Jan 2012

The new use for Prevnar 13 was approved under the agency's accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.

Read more 
XARELTO Application Submitted to U.S. FDA

XARELTO Application Submitted to U.S. FDA

30 Dec 2011

Janssen Research & Development, LLC has submitted a supplemental New Drug Application to the FDA seeking approval for the use of anticoagulant XARELTO.

Read more