Latest News in the pharma Industry

Policy & Regulation

India's Pharma Industry May Move Court on Barcoding Issue

India's Pharma Industry May Move Court on Barcoding Issue

20 Oct 2011

India's pharma industry may move court against the union commerce ministry's notification dated 10th January, 2011 under which barcoding was made mandatory for pharma exports, if the government does not amend the notification to make it exporter friend...

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Lux Biosciences Withdraws Marketing Authorisation Application for Luveniq

Lux Biosciences Withdraws Marketing Authorisation Application for Luveniq

19 Oct 2011

The company stated that they were unable to demonstrate to the satisfaction of the CHMP an overwhelming effect showing that the benefits of Luveniq outweigh its risks, and thus would qualify for a recommendation for authorisation with one pivotal study...

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NICE New Draft Guidance Recommends against Ipilimumab Use

NICE New Draft Guidance Recommends against Ipilimumab Use

18 Oct 2011

New draft guidance from the NICE recommends against the use of ipilimumab for advanced malignant melanoma in people who have received prior chemotherapy.

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Watson Files ANDA with FDA for Generic Daytrana

Watson Files ANDA with FDA for Generic Daytrana

17 Oct 2011

Watson Laboratories has filed an Abbreviated New Drug Application with the U.S. FDA for the marketing approval of Methylphenidate Transdermal System.

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India to Reimburse Product Registration Fees to Pharma Exporters

India to Reimburse Product Registration Fees to Pharma Exporters

14 Oct 2011

The move is considered to be a measure to motivate and encourage Pharmexcil members in export trade of pharmaceuticals.

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FDA Adds Warning to Leukemia Drug Sprycel

FDA Adds Warning to Leukemia Drug Sprycel

13 Oct 2011

The FDA said the drug can increase the risk of pulmonary arterial hypertension. The potential risk has been added to the warnings and precautions section of Sprycel's label.

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FDA Approves NDA for Fluoxetine Tablets 60 mg

FDA Approves NDA for Fluoxetine Tablets 60 mg

12 Oct 2011

The U.S. FDA has approved a New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

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Baxter Seeks European Approval for IG Therapy

Baxter Seeks European Approval for IG Therapy

10 Oct 2011

Baxter International has submitted an application to the EMA seeking marketing authorisation for the company's investigational immunoglobulin therapy.

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Tablet with Sitagliptin & Simvastatin Approved

Tablet with Sitagliptin & Simvastatin Approved

9 Oct 2011

The FDA approves Juvisync tablet, the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet.

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Horizon Pharma Submits NDA for RA Drug

Horizon Pharma Submits NDA for RA Drug

9 Oct 2011

The NDA submission is based on results from a 12 week double-blind placebo-controlled Phase 3 trial involving 350 rheumatoid arthritis patients.

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FDA Approves ANDA of Loxapine Capsules

FDA Approves ANDA of Loxapine Capsules

9 Oct 2011

Lannett Company has received approval from the FDA for its Loxapine Capsules in 5mg, 10mg, 25mg and 50mg doses.

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India's Commerce Ministry Calls for Policy Measures to Boost Pharma Exports to China

India's Commerce Ministry Calls for Policy Measures to Boost Pharma Exports to China

8 Oct 2011

A strategic paper by the Indian Commerce Ministry calls for critical policy interventions and special efforts to increase the presence of Indian pharma industry in China.

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