Latest News in the pharma Industry

Policy & Regulation

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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Santarus Submits NDA for UCERIS Tablets

Santarus Submits NDA for UCERIS Tablets

21 Dec 2011

UCERIS is being developed in collaboration with Cosmo Technologies. Upon acceptance for review of the NDA for UCERIS Tablets, $4 million is payable to Cosmo.

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EMA Issues Revised Guidance on Genotoxicity Testing of Medicines

EMA Issues Revised Guidance on Genotoxicity Testing of Medicines

20 Dec 2011

The revised guideline sets out the state of the art in genotoxicity testing and is expected to improve the assessment of the risks of human medicines.

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