Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix
Posted on15 Oct 2018
TagsBrintellix, CDSCO, codevelopment deal in pharma, comarketing deal in pharma, copromotion deal in pharma, DCGI, Lundbeck, vortioxetine
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Lundbeck India Private Limited (LIPL) announces the launch of Brintellix (vortioxetine) in India for the treatment of patients suffering from major depressive... Read More
Case Study: Product Recall due to labeling error
Posted on03 Oct 2018
Tagsclass i recall, FDA's role in product recall, medicine labeling, Product Recall, Produt recall, What is class i Recall
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Endo Pharmaceuticals Inc, is voluntarily recalling two lots of Robaxin (methocarbamol tablets, USP) 750mg tablets 100 count bottle pack to the consumer... Read More
Tildrakizumab (Ilumetri): Discovery, Development to Commercialization Case Study
Brand Name: Ilumetri Biomolecule: Tildrakizumab Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune... Read More
Indian health ministry banned 329 controversial fixed dose combination with immediate effect
The ministry of health and family welfare has prohibited the manufacture for sale, sale or distribution for human use of 329 fixed... Read More
Grünenthal’s Duzallo: EU marketing authorization and Brand Positining
Duzallo EU Marketing Authorization Grünenthal announced that the European Commission (EC) has followed the positive opinion of the Committee for Medicinal Products... Read More
USFDA approval of patisiran, first-of-its kind targeted RNA-based therapy
The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary... Read More
AstraZeneca’s Lynpraza got DCGI (India) marketing approval
AstraZeneca Pharma India has received Import & Market permission for olaparib (Lynparza )100 mg and 150 mg tablets in India by the... Read More
Pharma Packaging > How to convert IU to mg?
You will be finding the certain formulation is highlighting ingredients in IU. For example in case of Vitamin D preparation vitamin D3... Read More
EMA’s Prime Designation for Roche’s RG6042 – to treat Huntington’s disease
Roche announced that the European Medicines Agency (EMA) has granted Prime (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known... Read More
Insight on Bayer’s EU approval of new treatment regimen for Eylea
Bayer has received European Commission approval of a new treatment approach for Eylea to enable clinicians to combine proactive treatment with early... Read More