Latest News in the pharma Industry

Policy & Regulation

Arena Seeks European Marketing Approval for Lorcaserin

Arena Seeks European Marketing Approval for Lorcaserin

9 Mar 2012

Arena Pharmaceuticals has filed a Marketing Authorisation Application with the European Medicines Agency for the drug. The firm expects the agency to accept it later this month.

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FDA Accepts Eisai's Resubmission of Perampanel NDA

FDA Accepts Eisai's Resubmission of Perampanel NDA

6 Mar 2012

The FDA has accepted for review Eisai's resubmission of the New Drug Application for perampanel, an investigational drug for the treatment of partial-onset seizures associated with epilepsy.

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EMA Publishes Updated Set of Mandatory Article 57(2) Requirements for Marketing Authorisation Holders

EMA Publishes Updated Set of Mandatory Article 57(2) Requirements for Marketing Authorisation Holders

6 Mar 2012

Article 57(2) of the new pharmacovigilance legislation requires the Agency to establish lists of all human medicines authorised in the European Union (EU), based on structured data submitted by the marketing authorisation holders of these medicines.

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EMA Publishes List of Human Medicines under Evaluation

EMA Publishes List of Human Medicines under Evaluation

2 Mar 2012

The list only includes medicines whose applications have been validated. The Agency will update this information every month following the plenary meeting of the CHMP.

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India Plans to Frame Prescription Guidelines to Promote Rational Use of Drugs

India Plans to Frame Prescription Guidelines to Promote Rational Use of Drugs

29 Feb 2012

The proposed prescription guidelines will be made applicable not only in the government centres that are extending treatment for HIV and TB, but also for the private health facilities and providers.

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EC Approves Glivec Label Update

EC Approves Glivec Label Update

29 Feb 2012

The European Commission approved an update to the Glivec (imatinib) label to include 36 months of treatment with the drug following surgery for adults with KIT (CD117-positive) gastrointestinal stromal tumors (GIST).

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FDA Issues Draft Guidance on Heparin

FDA Issues Draft Guidance on Heparin

27 Feb 2012

The guidance is intended to alert manufacturers of APIs, pharmaceutical and medical device manufacturers of finished products, re-packers, and others on the potential risk of crude heparin contamination.

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EU Approves Skin Cancer Medicine Zelboraf

EU Approves Skin Cancer Medicine Zelboraf

23 Feb 2012

Zelboraf (vemurafenib), manufactured by Roche, has been approved by the European Commission, for treating patients with BRAF V600 mutationpositive unresectable or metastatic melanoma.

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AstraZeneca Receives EU Approval for Thyroid Cancer Treatment Caprelsa

AstraZeneca Receives EU Approval for Thyroid Cancer Treatment Caprelsa

23 Feb 2012

The approval is based on a Phase III trial that showed a 54% reduction in the risk of disease progression amongst the 331 patients involved in comparison to placebo.

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FDA Advisory Committee Recommends Approval of Qnexa

FDA Advisory Committee Recommends Approval of Qnexa

23 Feb 2012

The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the New Drug Application that was submitted for Qnexa in October 2011.

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EMA Focuses on New Legislation in 2012 Work Programme

EMA Focuses on New Legislation in 2012 Work Programme

21 Feb 2012

The Agency's activities this year will concentrate on the implementation of the pharmacovigilance legislation and preparations for the new legislation on falsified medicines.

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CDSCO to Set up Five New Labs for Cosmetics Testing

CDSCO to Set up Five New Labs for Cosmetics Testing

21 Feb 2012

The laboratories are being planned in line with the recent regulatory measures by the Health Ministry to ensure the quality of cosmetic products both manufactured domestically and imported from outside.

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