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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Eisai Announces Availability of BELVIQ® (lorcaserin HCl) CIV Tablets for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese BELVIQ Available in U.S. Pharmacies within One Week
LORCASERIN
june 7, 2013 –Eisai Inc. announced today that BELVIQ (pronounced BEL-VEEK) will be available to eligible patients by prescription in the United States beginning June 11.
BELVIQ was approved by the U.S. Food and Drug Administration on June 27, 2012 to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes your risk of heart problems or stroke, or of death due to heart problems or stroke.
“BELVIQ is a new treatment option for the medical management of patients who are obese and who have not been able to sustain long-term weight loss by altering their diets or increasing exercise alone,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. “Eisai is committed to making BELVIQ available to appropriate patients as part of our human health care corporate mission of keeping patients’ medical needs at the forefront of all that we do.”
BELVIQ will be available in U.S. pharmacies only with a prescription. Patients are cautioned not to buy BELVIQ from parties offering BELVIQ without a valid prescription from their doctor. Eisai will market and distribute BELVIQ in the United States and Arena Pharmaceuticals will manufacture and supply the finished commercial product from its facility in Switzerland.
“BELVIQ provides appropriate patients with a new treatment option that along with diet and exercise can help them lose weight and keep the weight off,” said Ken Fujioka, M.D., Director of the Center for Weight Management at the Scripps Clinic. “Obesity needs to be recognized and treated as a chronic disease. The availability of BELVIQ is a significant milestone in the medical management of overweight and obesity as we work to slow this epidemic in the United States.”
Lorcaserin (APD-356, trade name upon approval Belviq,expected trade name during development, Lorqess) is a weight-loss drug developed by Arena Pharmaceuticals. It has serotonergic properties and acts as an anorectic. On 22 December 2009 a New Drug Application (NDA) was submitted to the Food and Drug Administration (FDA) in the United States.On 16 September 2010, an FDA advisory panel voted to recommend against approval of the drug based on concerns over both safety and efficacy. In October 2010, the FDA stated that it could not approve the application for lorcaserin in its present form.
On 10 May 2012, after a new round of studies submitted by Arena, an FDA panel voted to recommend lorcaserin with certain restrictions and patient monitoring. The restrictions include patients with a BMI of over 30, or with a BMI over 27 and a comorbidity like high blood pressure or type 2 diabetes.
On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for adults with a BMI equal to or greater than 30 or adults with a BMI of 27 or greater who “have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol”.
On 07 May 2013, the US Drug Enforcement Administration has classified lorcaserin as a Schedule IV drug[10] under the Controlled Substances Act.
About BELVIQ (lorcaserin HCl) CIV Tablets
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known. BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence. For more information about BELVIQ,
Joint Pain: Medicine Kit of the Lower Pecos, Part II
Human beings have been plagued with joint pain throughout the history of mankind. Arthritis, the condition caused by the wearing down of beneficial cartilage in the joints, affects over 27 million people in the United States today, according to the Arthritis Foundation
(www.arthritistoday.org). I don’t know enough about the skeletal evidence from the Lower Pecos of Texas to do more than speculate, but at least some people in the region 4000-6000 years ago must have worn out a knee or two climbing up and down steep canyons and running over rough stone outcroppings in the uplands. In other words, they probably had their share of “archaic arthritis.”
Ow! Even that phrase hurts! Osteoarthritis produces stinging pain and can cause swelling and stiffness in the joints affected. Generally, the older you are, the more wear and tear you have on your joints. A stiff knee could make a thirty-year-old adult from the archaic period feel…
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Idenix Pharmaceuticals Announces Samatasvir (IDX719) Poster Presentations at the Asian Pacific Association for the Study of the Liver (APASL) Conference
New Hepititis C Virus Therapy
Idenix Pharmaceuticals Announces Samatasvir (IDX719) Poster Presentations at …
Wall Street Journal JUNE 6, 2013
… Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced three poster presentations featuring clinical and preclinical data for samatasvir (IDX719), …
READ ALL AT
http://online.wsj.com/article/PR-CO-20130606-905746.html
Idenix Pharmaceuticals, the Cambridge-based biotechnology company, announced that their drug, IDX719, was granted a Fast Track designation by the FDA. IDX719, an NS5A inhibitor, is designed to treat chronic hepatitis C virus (HCV) infection in patients. The Fast Track designation will enable Idenix Pharmaceuticals to shave precious time off their predicted timeline for a new drug application (NDA), and even increase interaction with the FDA to guarantee a quicker review and a shorter time to market.
Tasimelteon
Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder
WASHINGTON, June 5, 2013 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) presented additional entrainment and patient-level clinical data at SLEEP 2013, the 27th Annual Meeting of Associated Professional Sleep Societies in Baltimore, from its SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder) Phase III studies of tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in totally blind individuals. Non-24 is a serious, rare and chronic circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (synchronize) their master body clock to the 24-hour day. Currently there is no approved FDA treatment for Non-24.
In the SET study, tasimelteon achieved the primary endpoints of entrainment (synchronizing) of the melatonin (aMT6s) rhythm as compared to placebo and clinical…
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Biocon Seeks Partner to Sell Rival Drug to J J’s Stelara
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.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5630
Itolizumab (Alzumab) is a ‘first in class’ humanized IgG1 monoclonal antibody developed by Biocon. It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation.[1] A double blind, placebo controlled, phase III treat –Plaq study of Itolizumab, successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.[2] Biocon has received marketing authorization for the drug from the Drugs Controller General of India (DCGI).[3]
- http://www.biocon.com/docs/PR_080113.pdf?subLink=news
- http://www.thehindubusinessline.com/companies/article2789996.ece
- http://www.pharmabiz.com/NewsDetails.aspx?aid=73075&sid=2
OXYTOCIN , THE LOVE MOLECULE
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 processes. These include uterine contractions during childbirth, sexual arousal, lactation, puberty, orgasm, facial recognition, trust, memory formation and pair bonding.
Oxytocin is a cyclic peptide hormone with just nine amino acids in sequence (CYIQNCPLG) that also acts as a neurotransmitter in the brain where it is produced in the hypothalamus. It was the first ever polypeptide hormone to be sequenced and synthesized biochemically, work for which the American biochemist Vincent du Vigneaud was awarded the 1955 Nobel Prize in Chemistry.
Together with the neuropeptide argipressin (arginine vasopressin), it is believed to influence social cognition and behaviour. First shown in mice, recent studies have shown that also in humans simply sniffing a spray containing oxytocin increases a person’s level of trust in others.
References
- Lee, H.J., Macbeth, A.H., Pagani, J.H. and Young, W.S. (2009) Oxytocin: the great facilitator of life. Prog. Neurobiol. (Amsterdam, Neth.) 88, 127–151.
- du Vigneaud, V., Ressler, C., Swan, J.M., Roberts, C.W., Katsoyannis, P.G. and Gordon, S. (1953) The synthesis of an octapeptide amide with the hormonal activity of oxytocin. J. Am. Chem. Soc. 75, 4879–4880..
- Kosfeld, M., Heinrichs, M., Zak, P.J., Fischbacher, U. and Fehr, E. (2005) Oxytocin increases trust in humans. Nature 435, 673–676.
Oxytocin (ball-and-stick) bound to its carrier protein neurophysin (ribbons) based on: “Crystal structure of the neurophysin-oxytocin complex” Rose, J.P., Wu, C.K., Hsiao, C.D., Breslow, E., Wang, B.C. (1996) Nat.Struct.Biol. 3: 163-169
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
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 the Aliso Viejo, Calif., company’s revenue.
Nuedexta was approved in February 2011. The drug combines two ingredients: dextromethorphan, a common ingredient in cough and cold medicines that can suppress coughing, and quinidine, which is used to treat abnormal heart rhythms.
Avanir is also studying Nuedexta as a treatment for diabetic nerve pain, agitation in patients with Alzheimer’s disease, central nerve pain in multiple sclerosis, and levodopa-induced dyskinesia in Parkinson’s disease. Dyskinesias are involuntary movements tied to most treatments used to manage Parkinson’s.
Canaccord Genuity analyst Ritu Baral said Avanir considers AVP-786 to be a safer version of Nuedexta because it contains less quinidine. The drug also has stronger patent protection and is patent protected until 2030, a few years longer than Nuedexta.
In a telephone interview, Baral said the FDA’s decision could speed approval of AVP-786 by two to four years. She said Avanir may start late-stage testing of the drug in the second half of 2014 depending on the results of current studies of Nuedexta.
OPRD PAPER-An Improved Manufacturing Process for the Antimalaria Drug artemether
Management of Hepatitis C with Natural and Synthetic Medicine
Management of Hepatitis C with Natural and Synthetic Medicine by Khan Usmanghani, Asif Iqbal , Department of Basic Clinical Sciences, Faculty of Eastern Medicine , HAMDARD UNIVERSITY, Karachi, Pakistan
during the 6 th International Conference of Infection Control December 19, 2006 Liaquat National Hospital, Karachi
http://www.slideshare.net/icsp/management-of-hepatitis-c-with-natural-and-synthetic-medicine
Viral hepatitis is defined as viral infection of hepatocytes that produces necrosis and inflammation of the liver. Viral Hepatitis is a parenchymal disease of liver. This disease is caused by (a) Hepatotropic viruses A, B, C (Non-A-Non B), D,E,F,G,H (b) Other viruses like Epstein-Barr, Cytomegalovirus, and Coxsackie virus etc. Hepatitis C virus (HCV), the major causative agent of non-A and non-B hepatitis, poses a serious worldwide health problem. about 170 million people, 3% of the world’s population, are infected with HCV High prevalence rates Southeast Asian countries WHO
DENGUE FEVER by Prof. D. S. Akram, Dr. Saba Ahmed
Dengue fever (DF) and Dengue hemorrhagic fever (DHF) rank high among infectious diseases and are considered to be most important of arthropod born viral diseases
MOSQUITO VECTOR DF is caused by mosquito of genus Aedes ,most important is A.aegypti which is a day biting mosquito, rests indoors and can breed in small collection of water. Rainy season increase risk of DF as it increases larval population ,also ambient temperature and humidity favor viral propagation
New Drug Approvals 