Monday, 17 June 2013

Incyte Drug Jakafi ® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients with Myelofibrosis

ruxolitinib

Incyte Drug Jakafi®ruxolitinib Improved Overall Survival in Phase III Trial of Patients with Myel. by Business Wirevia The Motley Fool Jun 16th 2013 220AM ...


Ruxolitinib (trade names Jakafi and Jakavi, by Incyte Pharmaceuticals and Novartis) is a drug for the treatment of intermediate or high-risk myelofibrosis, a type of bone marrow cancer. It is also being investigated for the treatment of other types of cancer (such as lymphomas and pancreatic cancer), for polycythemia vera, and for plaque psoriasis.
The phase III Controlled Myelofibrosis Study with Oral JAK Inhibitor-I (COMFORT-I) and COMFORT-II trials showed significant benefits by reducing spleen size, relieving debilitating symptoms, and improving overall survival



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ABILIFY® Granted Additional Approval as Adjunctive Therapy for the Treatment of Depression in Japan



Otsuka Pharmaceutical Co., Ltd. today obtained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for ABILIFY as the first antsipsychotic drug in Japan to treat...

http://japan.pharmaintellect.com/2013/06/abilify-granted-additional-approval-as.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

Ibrutinib Phase 2 Data: Analyses Show Efficacy with Ibrutinib Monotherapy in Patients with Relapsed or Refractory Mantle Cell or Diffuse Large B-cell Lymphoma


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ibrutinib

June 16, 2013 

Janssen Research & Development, LLC (Janssen), today announced the results of two separate Phase 2 studies suggesting that ibrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor, shows efficacy when used as a monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL). The studies were presented today at the European Hematology Association (EHA) 18th Annual Congress in Stockholm, Sweden. Ibrutinib is being jointly developed by Janssen and Pharmacyclics, Inc.


Ibrutinib (USAN), also known as PCI-32765, is an experimental drug candidate for the treatment of various types of cancer. It is an orally-administered, selective and covalent inhibitor of the enzyme Bruton tyrosine kinase (Btk).

Ibrutinib is currently under development by Pharmacyclics, Inc and Johnson & Johnson's Janssen Pharmaceutical division for B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, diffuse large B-cell lymphoma, and multiple myeloma.

Ibrutinib was first designed and synthesized at Celera Genomics by Zhengying Pan, who along with a team of chemists and biologists reported in 2007 a structure-based approach for creating a series of small molecules that inactivate BTK through covalent binding to cysteine-481 near the ATP binding domain of BTK[2]. 
These small molecules irreversibly inhibited BTK by using a Michael acceptor for binding to the target cysteine. 

In April 2006, Pharmacyclics acquired Celera’s small molecule BTK inhibitor discovery program, which included a compound, PCI-32765 (known as compound 13 in the Pan et al paper) that was subsequently chosen for further preclinical development based on the discovery of anti-lymphoma properties in vivo . 

Since 2006, Pharmacyclics’ scientists have advanced the molecule into clinical trials and identified specific clinical indications for the drug.  It also has potential effects against autoimmune arthritis.

Sunday, 16 June 2013

Pharma-Execs-2012-Pipeline-Report

 
Just days before this article went to press, FDA approved the first of a new kind of oral enzyme treatment that mediates cellular response, Incyte/Novartis' Jakafi, for a rare bone marrow disease called myelofibrosis. The next JAK inhibitor, Pfizer's toficitinib, could hit the market late next year, meaning a lot of rheumatoid arthritis patients will never again have to sit in a hospital for a couple of hours to get an anti-TNF infusion. Many innovative drugs, long out of the gate, are closing in on the finish line; science is back, and a better understanding of the way genomics shapes disease is bringing about better outcomes, and sometimes faster approvals.

read all at

http://www.pharmexec.com/pharmexec/Deals/Pharm-Execs-2012-Pipeline-Report/ArticleStandard/Article/detail/752361?contextCategoryId=48159

Saturday, 15 June 2013

Amgen, Cytokinetics expand collaboration




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Omecamtiv mecarbil
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Omecamtiv mecarbil
Amgen, Cytokinetics expand collaboration
Thursday, June 13, 2013 01:30 PM
Amgen and Cytokinetics, a clinical-stage biopharmaceutical company, have expanded their strategic collaboration to include Japan. In 2006, Cytokinetics and Amgen entered into a collaboration to discover, develop and commercialize novel small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure. Omecamtiv mecarbil is the most advanced drug candidate in this collaboration.
- See more at:
 http://www.centerwatch.com//news-online/article/4852/amgen-cytokinetics-expand-collaboration

 Omecamtiv mecarbil , previously codenamed CK-1827452, is a cardiac specific myosin activator. It is clinically tested for its role in the treatment of left ventricular systolic heart failure. Systolic heart failure is characterised as a decreased cardiac output (<40% ejection fraction), due to decreased stroke volume, resulting in the inability to meet the metabolic demands of the body. The loss of contraction is caused by a reduced number of effective actin-myosin cross bridges in the left ventricular myocytes. One possible underlying mechanism is altered signal transduction that interferes with excitation-contraction coupling. A decreased cardiac output causes peripheral hypotension and activation of the sympathetic nervous system. This in turn stimulates the cardiac myocytes excessively, eventually leading to left ventricular hypertrophy, characteristic of chronic heart failure. Some symptoms of systolic heart failure are fatigue, peripheral oedema, dyspnoea, exercise intolerance and breathlessness. Current inotropic drug therapies such as dobutamine, are palliative and not a cure. They also cause many adverse effects including arrhythmias related to increased myocardical oxygen consumption, desensitization of adrenergic receptors and altering intracellular calcium levels. Thus systolic heart failure is considered malignant, however the novel mechanism of Omecamtiv Mecarbil is a hopeful long-term resolution.

Friday, 14 June 2013

The Design, Development and Scale-Up of Safe Chemical Processes and Operations



2 - 4 October 2013 • Chilworth Global, Princeton, NJ, USA

Dr Vahid Ebadat, Chilworth Technology Inc.

Dr. Swati Umbrajkar

Dr Will Watson, Scientific Update


Developing safe processes is of paramount importance to any chemical company. Exothermic chemical reactions in batch and semi- batch processes can result in serious injury to people and plant if they get out of control. Results of thermal runaways include violent loss of containment, possibly explosion and the release of flammable or toxic materials to the environment.
Employers are bound by Health & Safety legislation to ensure the safety of their employees and those outside their employment who might be affected by their activities. Chemical manufacturers must therefore be aware of all potential dangers in their processes and take steps to eliminate them. The best approach is to design safety into the process from the start.
This seminar is designed to enhance the awareness of chemists and engineers regarding hazard issues. Utilizing the expertise of the chemists and chemical engineers at Chilworth Global and Scientific Update, it will consider hazard control of new chemical processes throughout their development cycle: from early development through to full-scale production. Hazards can often be eliminated by appropriate choice of reagent or synthetic route at the R&D stage. Where this is not possible, techniques exist to quantify the hazards so that robust engineering solutions can he applied in production.

Who Should Attend?

  • R&D and Process Development Chemists, Chemical Engineers, Managers and anyone whose responsibilities include safety or risk assessment of chemical processes or building safety into chemical process scale-up.

Visit SCIENTIFIC UPDATE website for complete course information.