Latest News in the pharma Industry

Policy & Regulation

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FDA Issues Draft Guidance on Heparin

FDA Issues Draft Guidance on Heparin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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Korlym Approved for Patients with Endogenous Cushing's Syndrome

Korlym Approved for Patients with Endogenous Cushing's Syndrome

21 Feb 2012

Prior to FDA's approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing's syndrome.

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EMA Recommends Lifting Suspension of Aprotinin

EMA Recommends Lifting Suspension of Aprotinin

20 Feb 2012

The EMA has concluded that aprotinin’s benefits in preventing blood loss outweigh its risks in patients undergoing isolated heart bypass surgery who are at high risk of major blood loss.

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FDA Issues Warning Letters Regarding Counterfeit Avastin

FDA Issues Warning Letters Regarding Counterfeit Avastin

16 Feb 2012

FDA has notified 19 US medical practices that purchased fake 400 mg/16 mL Avastin from Quality Specialty Products (QSP), a foreign supplier that the agency said may also be known as Montana Health Care Solutions.

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EMA Publishes Guideline on Use of Pharmacogenetics in Evaluating Pharmacokinetics of Medicines

EMA Publishes Guideline on Use of Pharmacogenetics in Evaluating Pharmacokinetics of Medicines

15 Feb 2012

The guideline clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines.

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