New biologics approved by the US FDA's Center for Drug Evaluation and Research in 2008

FROM THE FOLLOWING ARTICLE:

2008 FDA drug approvals

Bethan Hughes

Nature Reviews Drug Discovery 8, 93-96 (February 2009)

doi:10.1038/nrd2813

Generic name (Trade name)	Company*	Indication(URL of label information if available)	Properties	Date
Rilonacept (Arcalyst)	Regeneron	Cryopyrin-associated periodic syndromes including familial cold autoinflammatory syndrome and Muckle–Wells syndrome (http://www.fda.gov/cder/foi/label/2008/125249lbl.pdf)	Interleukin-1 blocker	27 Feb (P, O)
Certolizumab pegol (Cimzia)	UCB	Crohn's disease (http://www.fda.gov/cder/foi/label/2008/125160s000lbl.pdf)	Tumour necrosis factor blocker	22 Apr (S)
Romiplostim (Nplate)	Amgen	Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (http://www.fda.gov/cder/foi/label/2008/125268lbl.pdf)	Thrombopoietin receptor agonist	22 Aug (P, O)
*The company that submitted the original biologic license application to the US FDA. O, FDA orphan designation; P, FDA priority review; S, FDA standard review.

Online access results in more citations?

Science 20 February 2009:Vol. 323. no. 5917, p. 1025DOI: 10.1126/science.1154562

Brevia
Open Access and Global Participation in Science

James A. Evans and Jacob Reimer
Previous investigations into the impact of open-access journals on subsequent citations confounded open and electronic access and failed to track availability over time. With new data, we separated these effects. We demonstrate that a journal receives a modest increase in citations when it comes online freely, but the jump is larger when it first comes online through commercial sources. This effect reverses for poor countries where free-access articles are much more likely to be cited. Together, findings suggest that free Internet access widens the circle of those who read and make use of scientists' investigations.

Free online availability of scientific articles increases the likelihood of papers getting cited, especially in the developing world and in the biomedical sciences, according to this new study published in Science.
The question of whether open access drives citations has been hotly contested among scientists, policymakers, and editors, with several recent studies coming down on different sides of the debate. In the most extensive study to date -- covering around 26 million articles from more than 8,000 journals published from 1998 to 2005 -- University of Chicago sociologist James Evans, together with neurobiology grad student Jacob Reimer, found that making an article freely available on the internet increased the number of citations, but only by about 8%, which was far less than some previous claims. When the authors looked just at poorer countries, however, they found that the influence of open access was more than twice as strong. For example, in Bulgaria and Chile, researchers cited nearly 20% more open access articles, and in Turkey and Brazil, the number of citations rose by more than 25%. Free online availability "is not a huge driver of science in the first world, but it shapes parts of science in the rest of world," Evans told The Scientist. "Scientists and scholars in poorer countries are disproportionately citing articles that are freely available to them." "The results make a lot of sense," Gunther Eysenbach, a health policy and e-health researcher at the University of Toronto who was not involved in the research, told The Scientist. "In countries with lower income, the [open access] effect is bigger than in countries where researchers have access to the literature anyway -- that's quite intuitive." Stevan Harnad, an open access advocate and cognitive neuroscientist at the University of Quebec at Montreal who was not involved with the study, said that the authors should have compared public and private institutions closer to home to test whether the same effect was true in the developed world. "[Evans] looked at the big picture, but he could have cut the cake a bit finer and found the same effects if he compared the Harvards and the have nots," Harnad told The Scientist. "It's a shame that with such rich data he didn't look at other such important and pressing questions." Free online access conferred the greatest citation advantage in the life sciences, and no significant influence in three areas -- chemistry, physics and the social sciences -- which the authors chalked up to a culture of pre-print databases and personal archiving. Although open access had a modest overall influence, commercial online availability had an even greater effect. This indicates that most researchers are turning to the internet to find papers, though they may rely largely on institutional subscriptions, said Evans. "The larger influence is of things being online," whether commercially or not. Philip Davis, a Cornell University grad student in science communications who also studies the effects of open access on citation records, praised the article's size and breadth, but noted that Evans "can't measure the article-level details, he can only look at the journal level." The study lumped together articles from entire journal volumes, which overlooks author-pay models that make some but not all articles in a journal freely available, Davis noted.

Fatty acids profile of edible oils and fats in our diet in India

http://timesofindia.indiatimes.com/India/Indian_refined_oils_safe_for_cooking/articleshow/4078251.cms

http://www.morungexpress.com/express_review/13494.html

http://www.cseindia.org/oil/soyabean.htm

Download the following pdf file and see Annexure II pages 38-40

http://www.cseindia.org/oil/fatty_acids_profile.pdf

Free online cources- Open CourseWare Consortium

An OpenCourseWare site...

• is a free and open digital publication of high quality educational materials, organized as courses.
• is available for use and adaptation under an open license.
• does not typically provide certification or access to instructors.

An OpenCourseWare is a free and open digital publication of high quality educational materials, organized as courses. The OpenCourseWare Consortium is a collaboration of more than 200 higher education institutions and associated organizations from around the world creating a broad and deep body of open educational content using a shared model. The mission of the OpenCourseWare Consortium is to advance education and empower people worldwide through opencourseware.

The Goals of the Consortium

• Extend the reach and impact of opencourseware by encouraging the adoption and adaptation of open educational materials around the world.
• Foster the development of additional opencourseware projects.
• Ensure the long-term sustainability of opencourseware projects by identifying ways to improve effectiveness and reduce costs

Find course materials by browsing individual OpenCourseWare sites or by searching across all courses. Unless otherwise noted, the links below are to English-language versions of the sites. Visit the following link http://www.ocwconsortium.org/use/use-dynamic.html

What is translational Pharmacology?

Rather than going through the well worked phrases of science that goes ‘from bench to bedside’ or from ‘mouse to man’, a more accurate definition might be ‘the application of biomedical research (pre-clinical and clinical), conducted to support drug development, which aids in the identification of the appropriate patient for treatment (patient selection), the correct dose and schedule to be tested in the clinic (dosing regimen) and the best disease in which to test a potential agent (disease segment)’. A challenge to say, let alone do, but it is fast becoming one of the most exciting research areas for pharmacologists to work in, as they get to see the translation of their hypotheses into the clinic for testing. 

Translational pharmacology (TP) can answer some simple questions once a drug candidate has emerged from a screening cascade. These include: 

   

• What disease might this agent work in? By testing in a number of pre-clinical models of human disease and working out whether this is predictive of disease in man some direction can be provided pre-clinically. 

• What dosing schedule can we test in the clinic for maximum therapeutic benefit with minimum toxicity, based upon the scientific profile of the molecule and data from pre-clinical models? 

• Can we use pharmacodynamic ‘biomarker(s)’ (measures of biological effect in man) to determine whether the compound blocks or stimulates the target receptor or enzyme in man as it does in animals (commonly known as proof of mechanism)? What effect does modulating the target have on the cellular phenotype that we might be trying to modulate (known as proof of principle, or proof of biology)? Does induction of this phenotypic change result in therapeutic benefit to the patient, and at what dose does this occur in the patients (proof of concept)? 

• Can we identify patients from within a disease population who might benefit from the agent, either by a gene mutational change or an over/under-expression of the protein target receptor or enzyme as examples? 

• If an agent is being developed as second or third in the market place (usually termed a ‘best in class’ agent), what differentiating pharmacology might this compound require in order to encourage regulatory agencies, physicians, and patients to test it? 

  Frankly speaking, TP is only a journey, not a specific scientific technique.

source: Netrum

Drug for Premature Ejaculation

A new drug has been designed that can treat premature ejaculation.  A major pharmaceutical company, Janssen-Ortho Inc., has filed an application with Health Canada to market the drug, dapoxetine, known by the brand name Priligy, in the country. Dapoxetine (brand name Priligy) is a short-acting SSRI drug for the treatment of premature ejaculation in men. Dapoxetine is the only drug with regulatory approved for such treatment. Currently, it is approved for use in Finland and Sweden and is being considered for approval in other European countries and in the United States where it is currently in Phase III of the FDA approval process. However, experts have claimed that the drug is not 100 percent successful.  "This is a really common problem," Globeandmail.com quoted Gerald Brock, a professor at the University of Western Ontario, as saying.  Brock, who has been involved with company-sponsored trials of the drug, has said that the condition can cause great emotional distress for men and their partners, and is believed to affect up to one-third of males. He revealed that, basically, these men lack sexual control and reach orgasm in less than two minutes. For a long time, scientists have suspected that serotonin plays a role in the disorder. And, sometimes patients are treated with a class of antidepressants known as SSRIs (selective serotonin reuptake inhibitors), which affect serotonin levels.  "The problem with SSRIs is that they are very slow to start working and they stay in your body for a long time," explained Brock.  And in order to treat premature ejaculation, an SSRI must be taken every day. Thus, scientists designed Priligy, which need to be taken about one to three hours before sexual intercourse.

Cell-based treatments for diabetes

In Type 1 diabetes mellitus the insulin-secreting b-cells in pancreatic islets of Langerhans are selectively destroyed by autoimmune assault. Because diabetes is caused by the loss of a single cell type it is amenable to treatment by cell replacement therapy. Advances in islet transplantation procedures have demonstrated that people with Type 1 diabetes can be cured by human islet transplantation, but the severely limited availability of donor islets has restricted the widespread application of this approach, and driven the search for substitute transplant tissues. Recent experimental studies suggest that three separate sources of tissue show therapeutic potential – xenografts from other species, tissue stem cells and embryonic stem cells. Of these, xenografts are closest to clinical application but there are still major obstacles to be overcome. Insulin-expressing cells have been derived from a number of different stem cell populations but embryonic stem cells offer the major advantage of being able, in principle, to provide the vast numbers of cells required for transplantation therapy.

For details visit http://www.drugdiscoverytoday.com/echoice/feb2009/Jones.pdf

DARPins: A new generation of protein

DARPins (designed ankyrin repeat proteins) are a novel class of binding molecules with the potential to overcome limitations of monoclonal antibodies, hence allowing novel therapeutic approaches. DARPins are small, single domain proteins (14 kDa) which can be selected to bind any given target protein with high affinity and specificity. These characteristics make them ideal agonistic, antagonistic or inhibitory drug candidates. Furthermore, DARPins can be engineered to carry various effector functions or combine multiple binding specificities, enabling completely new drug formats. Taken together, DARPins are a prominent member of the next generation of protein therapeutics with the potential to surpass existing antibody drugs.

For details visit http://www.drugdiscoverytoday.com/echoice/feb2009/Stumpp.pdf