AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

The art of antibody process development –Drug Discovery Today

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Jun 152013
 

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Figure 1. Schematic of an antibody. Pfizer’s developmental compound tremelimumab is an antibody of subclass IgG2 and is composed of four proteins linked by disulfide bonds. Many antibodies are glycosylated, meaning that polysaccharide structures are covalently attached to the proteins at distinct sites. An antibody can have several domains that have activity, including the variable regions on the arms of the heavy and light chains, which bind to antigens, and the Fc domains, which can mediate effector functions. Adapted with permission from Pfizer, Inc.

http://www.sciencedirect.com/science/article/pii/S1359644608001475

The art of antibody process development

Volume 13, Issues 13–14, July 2008, Pages 613–618

  • Global Biologics, Pfizer Global Research & Development, Chesterfield, MO, United States
  • Biopharmaceutical drug development is an intricate path that spans a dozen years from discovery through registration. The development of a therapeutic antibody presents substantial challenges, particularly with respect to the creation and implementation of manufacturing process technologies. Process development and large scale biotherapeutic manufacturing is an art generally only practiced within industry. As a consequence, these technologies may be seen as something of a ‘black box’ by many in the medical community. This article provides insight into the current art of antibody process development leading to market entry of novel, life-saving medicines.
  • http://www.sciencedirect.com/science/article/pii/S1359644608001475
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Does This Pipeline Promise Tomorrow’s Blockbuster Sales?

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Jun 142013
 

Does This Pipeline Promise Tomorrow’s Blockbuster Sales?
DailyFinance
The company currently has six drugs and indications under review for regulatory approval, with 15 more therapies undergoing phase 3 trials as of May 6. Those 21 drugs in total match up well with some of the top pipelines in the business. As a http://www.dailyfinance.com/2013/06/12/does-this-pipeline-promise-tomorrows-blockbuster-s/

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Tumor Immunotherapy Efficacy Increased In Both Breast And Prostate Cancer Preclinical Models With Addition Of Galectin Inhibitor

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Jun 132013
 

Tumor Immunotherapy Efficacy Increased In Both Breast And Prostate Cancer
Daily Markets
NORCROSS, Ga., June 12, 2013 /PRNewswire-USNewswire/ — Galectin Therapeutics (GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that preclinical studies have shown that The

http://www.dailymarkets.com/stock/2013/06/12/tumor-immunotherapy-efficacy-increased-in-both-breast-and-prostate-cancer-preclinical-models-with-addition-of-galectin-inhibitor/

 

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Emory University launches drug commercialization venture

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Jun 132013
 

Staff Writer- Atlanta Business Chronicle

Emory University launches drug commercialization venture

DRIVE will provide the financial, business, project management and regulatory expertise to effectively move drugs through pre-clinical testing – a stage of drug development often termed the “Valley of Death” — and into proof-of-concept clinical trials.

read all at

http://www.bizjournals.com/atlanta/blog/a-healthy-conversation/2013/06/emory-university-launches.html

 

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Celgene arthritis drug maintains efficacy at 52 weeks-study

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Jun 132013
 

apremilast

Celgene arthritis drug maintains efficacy at 52 weeks-study
Reuters
The U.S. biotechnology company had previously released positive data from the 500-patient Phase III trial called Palace-1 that compared its drug, apremilast, to a placebo through 16 weeks of treatment. The data being presented at the European League 

http://in.reuters.com/article/2013/06/11/celgene-arthritis-idINL2N0EN21P20130611

Apremilast is an orally available small molecule inhibitor of PDE4 being developed by Celgene for ankylosing spondylitis, psoriasis, and psoriatic arthritis.The drug is currently in phase III trials for the three indications. Apremilast, an anti-inflammatory drug, specifically inhibits phosphodiesterase 4. In general the drug works on an intra-cellular basis to moderate proinflammatory and anti-inflammatory mediator production.

Medical Use [Apremilast is being tested for its efficacy in treating “psoriasis, psoriatic arthritis and other chronic inflammatory diseases such as ankylosing spondylitis, Behcet’s disease, and rheutmatoid arthritis.”

Apremilast is being tested for its efficacy in treating “psoriasis, psoriatic arthritis and other chronic inflammatory diseases such as ankylosing spondylitis, Behcet’s disease, and rheutmatoid arthritis.”

 

 

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Generic Licensing News, Featured product, Bosentan

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Jun 122013
 

Generic Licensing News

http://www.leadformix.com/ef1/preview_campaign.php?lf1=900485181e199412625317a3906967

Click here to contact Zack Systems SpA about this product.

 

BOSENTAN

Bosentan is a dual endothelin receptor antagonist important in the treatment of pulmonary artery hypertension (PAH).

Bosentan belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Patients with PAH have elevated levels of endothelin, a potent blood vessel constrictor, in their plasma and lung tissue. Bosentan blocks the binding of endothelin to its receptors, thereby negating endothelin’s deleterious effects.

bosentan

Bosentan is a dual endothelin receptor antagonist used in the treatment of pulmonary artery hypertension (PAH). It is licensed in the United States, the European Union and other countries by Actelion Pharmaceuticals for the management of PAH under the trade name Tracleer.

Bosentan is indicated mainly for the treatment of pulmonary hypertension. In 2007, bosentan was approved in the European Union also for reducing the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.Bosentan is a competitive antagonist of endothelin-1 at the endothelin-A (ET-A) and endothelin-B (ET-B) receptors. Under normal conditions, endothelin-1 binding of ET-A or ET-B receptors causes pulmonary vasoconstriction. By blocking this interaction, bosentan decreases pulmonary vascular resistance. Bosentan has a slightly higher affinity for ET-A than ET-B.

In the United States, bosentan is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class II-IV symptoms, to improve exercise capacity and decrease the rate of clinical worsening.[1]

Warnings

Due to potential hepatotoxicity, the FDA requires monthly monitoring of liver function tests while taking Bosentan.

Bosentan use requires hematocrit monitoring due to potential onset of anemia. [2]

Hormone-based contraception is not possible in women taking Bosentan, due to a pharmacokinetic interaction. [3]

Bosentan is absolutely contraindicated in pregnancy because of its teratogenicity. Category X.

  1. http://www.tracleer.com/pdf/09%20276%2001%2000%200809_Tra%20PI_4%20Pg_081409pdf.pdf
  2. http://www.ionchannels.org/showabstract.php?pmid=15875338
  3. http://www.ionchannels.org/showabstract.php?pmid=15875338

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