Latest News in the pharma Industry

Policy & Regulation

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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EMA Recommends Approval of Vimpat Syrup

EMA Recommends Approval of Vimpat Syrup

19 Dec 2011

Once approved by the European Commission, the 10-mg/ml syrup will provide a new treatment option that can be taken by mouth by patients who have difficulty swallowing tablets.

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India's OPPI Urges DoP to Reconsider Price Regulation on APIs

India's OPPI Urges DoP to Reconsider Price Regulation on APIs

19 Dec 2011

OPPI urges the reconsideration of para 4(2) recommendation that price regulation would not apply to any upstream products such as bulk drugs and intermediates.

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Gilead Submits sNDA to FDA for Truvada

Gilead Submits sNDA to FDA for Truvada

16 Dec 2011

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP.

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IPC to Release Latest Amendments to Indian Pharmacopoeia

IPC to Release Latest Amendments to Indian Pharmacopoeia

16 Dec 2011

The latest amendment have been made with a view to look over the licensing of manufacturing, inspection and distribution of medicines to ensure quality and efficacy of the medicines.

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Salix Submits Application for Crofelemer to FDA

Salix Submits Application for Crofelemer to FDA

15 Dec 2011

The FDA has 60 days to review its filing and determine whether it is complete and ready for a more substantial review.

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COMP Recommends Orphan Designation for Nine Substances

COMP Recommends Orphan Designation for Nine Substances

14 Dec 2011

The COMP recommendations for these substances are now being sent to the European Commission for the adoption of a decision.

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