Latest News in the pharma Industry

Policy & Regulation

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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IPEC Federation Launches New Certification Scheme EXCiPACT

IPEC Federation Launches New Certification Scheme EXCiPACT

14 Feb 2012

The voluntary international certification scheme has been designed and developed to assure that cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients.

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India Releases National Policy on NDPS

India Releases National Policy on NDPS

14 Feb 2012

The NDPS policy will serve as a guide to various ministries and organizations and re-assert India's commitment to combat the drug menace in a holistic manner.

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FDA Grants Roche's Pertuzumab Priority Review

FDA Grants Roche's Pertuzumab Priority Review

14 Feb 2012

Roche announced that the FDA has accepted the company's Biologics License Application for pertuzumab and granted Priority Review.

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FDA Approves Shire's ADHD Drug Vyvanse for Maintenance Therapy in Adults

FDA Approves Shire's ADHD Drug Vyvanse for Maintenance Therapy in Adults

9 Feb 2012

The drug is Shire’s top-selling pharmaceutical, achieving sales of $199.7 million in the three months to September 30 2011, up 32% on the same period in 2010.

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