Latest News in the pharma Industry

Policy & Regulation

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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AstraZeneca Wins Japanese Approval for Faslodex

AstraZeneca Wins Japanese Approval for Faslodex

30 Sep 2011

AstraZeneca has received regulatory approval for its breast cancer drug Faslodex (fulvestrant) 500mg in Japan.

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Takeda Submits New Drug Application for TAK-085

Takeda Submits New Drug Application for TAK-085

30 Sep 2011

Takeda has submitted a New Drug Application in Japan for TAK-085 for the treatment of hyperlipidemia.

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HHS Launches New Initiative to Strengthen Primary Care

HHS Launches New Initiative to Strengthen Primary Care

29 Sep 2011

Under the new initiative, Medicare will work with commercial and state health insurance plans to offer additional support to primary care doctors who better coordinate care for their patients.

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Novartis Receives Japanese Regulatory Approval for Two Innovative Therapies

Novartis Receives Japanese Regulatory Approval for Two Innovative Therapies

28 Sep 2011

The Japanese regulators have approved Novartis' once-daily Gilenya (fingolimod) 0.5mg and Illaris (canakinumab) subcutaneous injection 150mg in the Japanese market.

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India Releases Guidelines for Conservation & Development of Medicinal Plants

India Releases Guidelines for Conservation & Development of Medicinal Plants

28 Sep 2011

The scheme released by India's Department of Ayush aims to promote availability of quality plant based raw material.

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Boehringer Ingelheim Receives EU Approval for Viramune Once-daily Formulation

Boehringer Ingelheim Receives EU Approval for Viramune Once-daily Formulation

28 Sep 2011

Boehringer Ingelheim has received European approval for its once-daily Viramune tablets for HIV treatment.

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