Case Study: ORS L – J&J to acquire?
The world’s sixth largest consumer health and pharma giant Johnson & Johnson (J&J) has emerged as a front-runner to acquire electrolyte energy... Read More
Role of Product Management Team in a Pharmaceutical Company
Posted on29 Oct 2014
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The Product Management Team in a pharmaceutical company is responsible for developing and implementing marketing plans for target audience. Every Company in... Read More
Why Biosimilar has different approval process from generic drugs?
Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers... Read More
What is the meaning of summary of product characteristics (SmPC)?
Posted on28 Oct 2014
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A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis... Read More
Committee for Medicinal Products for Human Use (CHMP)
Posted on28 Oct 2014
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The Committee for Medicinal Products for Human Use (CHMP) is the committee at the European Medicines Agency that is responsible for preparing... Read More
Duavive – Pfizer’s new molecule receive positive opinion for marketing authorisation in EU
Category: Oestrogens and HRT Pharmacology: A combination of the third generation selective estrogen receptor modulator (SERM), bazedoxifene, and the conjugated estrogen, Premarin... Read More
FDA Approves Boehringer Ingelheim’s OFEV® (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved OFEV® (nintedanib) capsules for oral use for the... Read More
Case Study: FDA approves Esbriet® (pirfenidone) to treat idiopathic pulmonary fibrosis
The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is... Read More
New molecule approved by USFDA tilldate in 2014
Posted on27 Oct 2014
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2014 New Molecule Approved tilldate No. Drug Name Active Ingredient Date What It’s Used For 34 Esbriet pirfenidone 15-10-2014 For the treatment of... Read More
New Drug Approved in 2013 by USFDA
Posted on27 Oct 2014
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No. Drug Name Active Ingredient Date What it’s used for 1 Nesina alogliptin 1/25/2013 To improve blood sugar control in adults with... Read More