Lorcaserin: a selective serotonin receptor (5-HT2C) agonist for the treatment of obesity

Lorcaserin is a selective serotonin receptor (5-HT2C) agonist that recently received the U.S. Food and Drug Administration (FDA) approval for chronic weight management. The efficacy of this drug in reducing body weight and improving metabolic parameters of obese patients has been demonstrated in three phase-3 clinical trials. The available evidence indicates that this drug does not show heart valve abnormalities, and the treatment improves the risk factors for type 2 diabetes and cardiovascular diseases. However, the drug’s manufacturer will be required to conduct postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Lorcaserin on the risk for major adverse cardiac events such as heart attack and stroke

Article level metrics: a look beyond the journal impact factor

The journal Impact Factor (IF), developed by Eugene Garfield at the Institute for Scientific Information (ISI), reflects the average number of times articles from the journal published in the past two years have been cited in the Journal Citation Reports (JCR) year. The Impact Factor is calculated by dividing the number of citations in the JCR year by the total number of articles published in the two previous years. For example, if there were 200 papers published in a journal in 2013 and 2014 and there were 400 citations in that time period, then the 2015 IF for the journal would be 2. Impact Factor uses Thomson Reuters (ISI Web of Knowledge) citation data. The Impact factor citation data was first derived from the Science Citation Index, a citation index created by Garfield and produced by the Institute for Scientific Information (ISI). ISI was later acquired by Thomson Reuters along with the Science Citation Index, which Reuters grew into the Science Citation Index Expanded. That index is now housed in the Web of Science, a subscription-based scientific citation indexing service encompassing six other online databases. Today, Thomson Reuters calculates IFs using the data from all of the journals indexed in the Web of Science, and releases an IF listing on an annual basis in its yearly Journal Citation Reports, which is available with paid Web of Science subscriptions

Editorial

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Wound healing and anti-inflammatory activity of extract of Ficus racemosa linn. bark in albino rats

Background: F. racemosa is an indigenous plant having anti-secretory, anti-diabetic, anti-ulcer etc. properties. It is used widely in the ayurvedic medicines.Methods: The experimental models of wound and inflammation were used to assess the wound healing and anti-inflammatory properties of F. racemosa. The significance of differences was analyzed using students’ ‘t’ test.Results: In the strength of 10% local application it could apparently enhanced the process of healing. At the dose of 20 mg/100 gm intraperitoneally it could show inhibition of carageenan induced acute inflammation at 3rd, 5th and 7th hour and at the dose of 30 mg/100 gm intraperitoneally, formalin induced subacute inflammation was inhibited till 4th day. The results were found statistically significant.Conclusions: Aqueous extract of F. racemosa has got wound healing and anti-inflammatory activity. It is likely that the duration of action may be shorter

Approval of antineoplastic agents in India: comparison with the US and EU regions

Background: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU).Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions.Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months).Conclusions: This study confirms that India’s drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India

Ivermectin: pharmacology and therapeutic applications

Ivermectin is an antiparasitic drug with a broad spectrum of activity, high efficacy as well as a wide margin of safety. It belongs to the family of avermectins. It binds to glutamate-gated chloride iron channels, which are present in invertebrate nerve and muscle cells, and causes the paralysis and death of the parasite. Ivermectin is approved by the US Food and Drug Administration, and used worldwide to treat patients with onchocerciasis and strongyloidiasis. It is also used against a wide range of endoparasites (nematodes) and ectoparasites (insects, acarine) of animals and humans

Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals

Background: There is a tremendous amount of research being conducted on development of new drugs for cancer therapies. The drug development of cancer therapies has dramatically increased over the past few decades. The present study was undertaken to assess the drug lag for new antineoplastic and immunomodulating agents in India compared with that in the United States (US) or European Union (EU).Methods: The new drugs approved in the US, EU and India between 2011 and 2015 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date. We assessed the absolute and relative drug lag for new antineoplastic and immunomodulating agents approved in the three regions (with the ATC code L).Results: Of the 67 new antineoplastic and immunomodulating agents, 63 (94.02%) were approved in the United States, 58 (86.56%) in the European Union and 18 (26.86%) in India. The US was the first to approve 59 (88.05%) out of the 67 new antineoplastic and immunomodulating agents, the EU was the first to approve 7 (10.44%) and India was the first to approve 1 (1.49%). The median approval lag for India (18.36 months) was higher as compared to the United States (0 month) and European Union (6.02 months).Conclusions: This study confirms that India lag behind the US and EU regions in terms of total number of new drug approvals for antineoplastic and immunomodulating agents. There is a substantial approval delay in India compared to the US and EU regions. Further detailed analyses are necessary to find the reasons and impacts of drug lag for new antineoplastic and immunomodulating agents in India

Comparison of new drug approval by regulatory agencies of US, EU and India

Background: As per World Trade Organisation (WTO), from the year 2005, India granted product patent recognition to all new chemical entities (NCEs). This may affect the new drug approvals in India. The purpose of this study was to compare the new drug approvals in India with the United States (US) and the European Union (EU) regions.Methods: We obtained information about regulatory approval of new drugs in the US, EU, or India of last 5 years (from 2011 through 2015) from the publicly accessible databases of three regulatory agencies. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date.Results: There were 509 new drugs approved from 2011 through 2015 by one or more of the three regulatory agencies. Total 182 new drugs were approved in US during the period of 2011 to 2015, with an average of 36.4 new drugs approved per year. For the same period a total of 257 new drugs were approved in the EU, with an average of 51.4 new drugs approved per year and in India a total of 70 new drugs were approved, with an average of 14 new drugs approved per year. There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group in all the three regions (US= 66; EU= 61 and India= 17).Conclusions: For new drugs approved between 2011 and 2015, India has lagged behind the US and the EU in approval of new drugs. There was no difference in the patterns of new drug approvals with respect to the therapeutic areas

Contemplation on new drug approvals by U.S. FDA, 2011-2015

Background: The U.S Food and Drugs Administration (FDA) is the world's leading drug regulatory authority. There are reports of more product pipelines in oncology therapy area. The objective of this study was to see the overall trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals.Methods: New drug approvals data obtained from publicly available databases of the U.S. FDA from 2011 through 2015. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, single or combination products, New Drug Application (NDA) chemical types, review classification and approval date.Results: There were 182 new drugs approved from 2011 through 2015 by the U.S. FDA with a mean of 36.4 approvals per year. Out of these 182 new drug approvals, 149 (81.87%) approvals were for new molecular entity (NME) and 33 (18.13%) for biologics license application (BLA). There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group (n=66; 36.26% of total new drug approvals).Conclusions: For new drugs approved between 2011 and 2015, the U.S. FDA was first to approve majority of new drugs. There was upward trend of new drug approvals in antineoplastic therapeutic area

Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals

Objective: Age-standardized burden of cardiovascular diseases is substantially higher in low and middle-income countries than in high-income countries. However, Indian patients are not getting access to the new cardiovascular drugs at the same time as patients in the developed nations. The objective of this study was to assess the drug lag for new cardiovascular drugs in India compared with that in the United States (US) or European Union (EU). Methods: The information regarding approval of new cardiovascular drugs in the United States, European Union and India between 1999 and 2011 were obtained primarily from the online databases of regulatory agencies. The approval lag was obtained for all new cardiovascular drugs approved in each region, and the median approval lag was calculated for each region. Results: Of the 75 new cardiovascular drugs, 61 (81.33%) were approved in the United States, 65 (86.66%) in the European Union and 56 (74.66%) in India. The US was the first to approve 35 (56.45%) out of the 75 new cardiovascular drugs, the EU was the first to approve 24 (38.71%) and India was the first to approve 3 (4.84%). The median approval lag for India (44.14 months) was substantially higher as compared to the United States (0 month) and European Union (2.99 months). Conclusion: This study confirms that there is a substantial drug lag in approval of new cardiovascular drugs in India compared with the United States and European Union. The impact of drug lag on health outcomes remains to be established