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Monthly Archives: June 2013

Avanir said the FDA agreed to a faster development process for its experimental drug AVP-786 and will allow the company to use some data from studies of Nuedexta in its applications for AVP-786

New Drug Approvals

6/may/2013

Avanir Pharmaceuticals Inc. announced that the Food and Drug Administration will allow it to speed research on a newer version of its drug Nuedexta.

Avanir said the FDA agreed to a faster development process for its experimental drug AVP-786 and will allow the company to use some data from studies of Nuedexta in its applications for AVP-786.

Avanir plans to start human clinical trials of the drug after it completes some limited preclinical testing. The company said the FDA’s decision could reduce the cost of developing the drug and allow it to win marketing approval sooner.

Nuedexta is a treatment for pseudobulbar affect, a condition that involves involuntary emotional outbursts like laughing or crying. It is associated with brain disease or injury. Net revenue from the drug more than doubled to $31.4 million over the first six months of the company’s current fiscal year. That was almost all of…

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Posted by on June 7, 2013 in Uncategorized

 

OXYTOCIN , THE LOVE MOLECULE

New Drug Approvals

OXYTOCIN

1-({(4R,7S,10S,13S,16S,19R)-19-amino-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-16-(4-hydroxybenzoyl)-13-[(1S)-1-methylpropyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl}carbonyl)-L-prolyl-L-leucylglycinamide

Oxytocin  is a mammalian neurohypophysial hormone that acts primarily as a neuromodulator in the brain.

Oxytocin plays roles in sexual reproduction, in particular during and after childbirth. It is released in large amounts after distension of the cervix and uterus during labor, facilitating birth, maternal bonding, and, after stimulation of the nipples, breastfeeding. Both childbirth and milk ejection result from positive feedback mechanisms.

Recent studies have begun to investigate oxytocin’s role in various behaviors, including orgasm, social recognition, pair bonding, anxiety, and maternal behaviors. For this reason, it is sometimes referred to as the “love hormone”. There is some evidence that oxytocin promotes ethnocentric behavior, incorporating the trust and empathy of in-groups with their suspicion and rejection of outsiders. Furthermore, genetic differences in the oxytocin receptor gene (OXTR) have been associated with maladaptive social traits such as aggressive behaviour.

Oxytocin , sometimes known as the “love molecule” or the “trust molecule” plays an important role in many…

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Posted by on June 7, 2013 in Uncategorized

 

Cadila banks on diabetes drug,Lipaglyn,Saroglitazar

New Drug Approvals

Saroglitazar skeletal.svg

(2S)-2-Ethoxy-3-[4-(2-{2-methyl-5-[4-(methylsulfanyl)phenyl]-1H-pyrrol-1-yl}ethoxy)phenyl]propanoic acid

(αS)-α-Ethoxy-4-[2-[2-methyl-5-[4-(methylthio)phenyl]-1H-pyrrol-1-yl]ethoxy]benzenepropanoic Acid

  1. alpha-ethoxy-4-(2-(2-methyl-5-(4-methylthio)phenyl))-1H-pyrrol-1-yl)ethoxy))benzenepropanoic acid
  2. alpha-ethoxy-4-(2-(2-methyl-5-(4-methylthio)phenyl))-1H-pyrrol-1-yl)ethoxy))benzenepropanoic acid magnesium salt
  3. saroglitazar
  4. ZYH1 compound
    1. E0YMX3S4JD
    2.  cas no 495399-09-2

Saroglitazar, Lipaglyn

Molecular Weight 439.56706 g/mol
Molecular Formula C25H29NO4S

Cadila Healthcare Ltd

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Zydus Cadila chairman and MD Pankaj R. Patel (centre) and deputy managing director Sharvil P. Patel (left) in Mumbai on Wednesday. (PTI)JUNE 5, 2013

Cadila banks on diabetes drug
Calcutta Telegraph
It generally takes around 10-15 years for a drug to be developed from the time of its discovery In the case of Lipaglyn, the molecule was identified in 2001, and Phase III clinical trials was completed around four years ago. While Zydus has not yet http://www.telegraphindia.com/1130606/jsp/business/story_16976915.jsp

Mumbai, June 5: Cadila Healthcare will launch a homegrown drug against diabetes by the third quarter of this year.

The Drug Controller General of India has approved its drug — Lipaglyn —…

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Posted by on June 7, 2013 in Uncategorized

 

Biocon Seeks Partner to Sell Rival Drug to J J’s Stelara

New Drug Approvals

Biocon Managing Director Kiran Mazumdar-Shaw

Managing Director Kiran Mazumdar-Shaw, BIOCON

Photographer-Namas Bhojani/Bloomberg

Rapid commercialization of Alzumab “will be transformational for us,” said Kiran Mazumdar-Shaw, chairman and managing director of Biocon Ltd.

Managing Director Kiran Mazumdar-Shaw,  is seeking a partner to help with expertise and funding for the tests needed for approval in the U.S., she said in an interview. Biocon plans to file for permission in the year ending March to sell in the North American nation, and aims to start marketing Alzumab in that country two to three years later, she said.

Alzumab would provide a novel therapy for a plaque-causing form of the immune disorder that would compete with best-selling products from Johnson & Johnson, AbbVie Inc. and Pfizer Inc. (PFE) The biologic psoriasis treatment, made from living cells, will help Biocon enter a market that it estimates will be valued at $8 billion by 2016.

READ ALL AT

http://www.bloomberg.com/news/2013-06-05/biocon-seeks-partner-to-sell-rival-drug-to-j-j-s-stelara.html

http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5630

Itolizumab (Alzumab)…

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Posted by on June 7, 2013 in Uncategorized

 

GENERICS WEB- RALOXIFENE (DRUG IN FOCUS)

 
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Posted by on June 1, 2013 in Uncategorized

 

Ireland passes reference pricing, pro-generics law

 
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Posted by on June 1, 2013 in Uncategorized

 

FDA Accepts sNDA for Higher Concentration Dose of Copaxone

New Drug Approvals

Teva Announces FDA Acceptance of sNDA for a Higher Concentration Dose of COPAXONE® Given Three Times a Week

http://www.pharmalive.com/fda-accepts-snda-for-higher-concentration-dose-of-copaxone

Glatiramer acetate (also known as Copolymer 1Cop-1, or Copaxone – as marketed by Teva Pharmaceuticals) is an immunomodulator drug currently used to treat multiple sclerosis. It is a random polymer of four amino acids found in myelin basic protein, namelyglutamic acid, lysine, alanine, and tyrosine, and may work as a decoy for the immune system. Glatiramer acetate is approved by the Food and Drug Administration (FDA) for reducing the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability.

Although the clinical definition of multiple sclerosis requires two or more episodes of symptoms and signs, glatiramer acetate is approved for treatment after single episodes. It is also used to treat relapsing-remitting multiple sclerosis. It is administered bysubcutaneous injection.

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Posted by on June 1, 2013 in Uncategorized

 
 
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