Latest News in the pharma Industry

Policy & Regulation

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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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.

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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.

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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.

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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.

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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.

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Perrigo Gets FDA Final Approval for Desloratadine

Perrigo Gets FDA Final Approval for Desloratadine

28 Dec 2011

Perrigo has received final approval from the FDA for its ANDA for Desloratadine tablets.

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French Regulator Clears United Therapeutics’ Remodulin for PAH Therapy

French Regulator Clears United Therapeutics’ Remodulin for PAH Therapy

28 Dec 2011

The clearance follows a review period during which 22 EU member states endorsed the final variation assessment report issued by AFSSAPS.

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India's Commerce Ministry Decides to Extend 2nd Phase of Barcoding Implementation

India's Commerce Ministry Decides to Extend 2nd Phase of Barcoding Implementation

26 Dec 2011

The second phase of barcoding will become mandatory from July 1, 2012 along with the third phase of barcoding on primary level packaging.

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HMPC to Strengthen Integration of Herbal Medicines in Pharmaceutical Legislative Framework

HMPC to Strengthen Integration of Herbal Medicines in Pharmaceutical Legislative Framework

23 Dec 2011

A work programme for 2012-2015 aims to strengthen the integration of herbal medicines in the pharmaceutical legislative framework.

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FDA Accepts New Drug Application for Tofacitinib

FDA Accepts New Drug Application for Tofacitinib

23 Dec 2011

The FDA has accepted a new drug application for tofacitinib for review.

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