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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Watermelon Juice Prevents Aching Muscles Food Chemistry: The amino acid L-citrulline found in the fruit could help athletes avoid muscle soreness after a hard workout
India seeks to cancel Roche cancer patent
India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act
India’s health ministry is looking to revoke Roche’s breast cancer drug’s patent in public interest using powers under section 66 of the Indian Patents Act India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act Related Articles Oramed gets Japanese patent for protein delivery Cipla wins patent case against Roche Alchemia cancer drug gets US patent protection Alchemia gets US patent for oncology platform technology New Delhi: India’s health ministry has asked for a cancellation of patent to Roche’s breast cancer medicine Trastuzumab, using a rarest-of-the-rare provision in the Indian Patents Act.
Read more at: http://www.biospectrumasia.com/biospectrum/news/192436/india-seeks-cancel-roche-cancer-patent#.UfXtuaI3CSo
Kyowa Hakko Kirin Korea begins patient recruitment in phase I/II study of BIW-8962 in lung cancer
Kyowa Hakko Kirin Korea begins patient recruitment in phase I/II study of BIW-8962 in lung cancer
http://www.kyowa-kirin.com/news_releases/2011/pdf/e20110802_04.pdf
http://clinicaltrials.gov/ct2/show/NCT01898156
Kyowa Hakko Kirin Korea Co., Ltd
This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 and preliminary efficacy in Phase 2 in subjects with advanced/recurrent lung cancer or mesothelioma.
http://www.myeloma.org.uk/patient-information/drug-development/hcp-drug-scanner/biw-8962/
UK regulator approves access to Revolade drug after three-year process
25 July 2013
The National Institute for Health and Care Excellence (NICE) in the UK has recommended immune disorder drug Revolade for use on the NHS after a process of three and a half years.
The GSK once-daily oral treatment is now available to adult patients in England and Wales living with chronic immune (idiopathic) thrombocytopenic purpura (cITP), an immune disorder associated with low-blood platelet counts.
In patients with cITP, the immune system prematurely destroys platelets or impairs their production so that platelets are lost from the circulation faster than they can be replaced from the bone marrow, where they are made.
This results in patients developing mild bruising or serious bleeding, which affects their quality of life and, in some instances, may be fatal.
It is estimated that cITP currently affects 50 in 100,000 people in the UK.
The only other licensed TPO-RA recommended by NICE is romiplostim, which is given in the form of a weekly injection.
The Royal London Hospital’s clinical director for pathology Prof Adrian Newland said: “I was very pleased to see that NICE has recognised the clinical value and cost-effectiveness of eltrombopag in their guidance.
“We now have an important addition to the treatment options for patients with severe or refractory disease.”
Revolade is an oral thrombopoietin receptor agonist (TPO-RA) that stimulates the growth and maturation of cells in the bone marrow (megakaryocytes) that produce platelets, increasing platelet production.
When added to conventional immunosuppressive therapy, Revolade, also known as eltrombopag, increases response rates compared with placebo and in some patients.
GlaxoSmithKline UK general manager Erik Van Snippenberg said: “This has been a lengthy three and a half year long appraisal process. We are pleased that NICE has recommended eltrombopag and that the small number of cITP patients in England and Wales are granted access to an alternative treatment option offering the benefit of oral convenience.
“With eltrombopag, we hope to ultimately make a meaningful difference in the quality of life of cITP patients and contribute to potential savings for the NHS.”
Compound Suffocates Tumors
Scientists have discovered a new molecule that prevents cancer cells from responding and surviving when starved of oxygen and which could be developed into new treatments for the disease, according to new research published in the Journal of the American Chemical Society.
Cancer Research UK scientists at the University of Southampton found that this molecule targets the master switch—HIF-1—that cancer cells use to adapt to low oxygen levels, a common feature in the disease.
read all at
Find out more:
- Cancer Sciences Unit
- Is it your ambition to help cure cancer? If so, visit: www.southampton.ac.uk/medicine/undergraduate/index.page
Hepatitis B
Hepatitis B
Key facts
- Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease.
- The virus is transmitted through contact with the blood or other body fluids of an infected person.
- About 600 000 people die every year due to the consequences of hepatitis B.
- Hepatitis B is an important occupational hazard for health workers.
- Hepatitis B is preventable with the currently available safe and effective vaccine.
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus. It is a major global health problem. It can cause chronic liver disease and chronic infection and puts people at high risk of death from cirrhosis of the liver and liver cancer.
More than 240 million people have chronic (long-term) liver infections. About 600 000 people die every year due to the acute or chronic consequences of hepatitis B.
A vaccine against hepatitis B has been available since 1982. Hepatitis B vaccine is 95% effective in preventing infection and its chronic consequences, and was the first vaccine against a major human cancer.
Geographical distribution
Hepatitis B virus can cause an acute illness with symptoms that last several weeks, including yellowing of the skin and eyes (jaundice), dark urine, extreme fatigue, nausea, vomiting and abdominal pain. Hepatitis B prevalence is highest in sub-Saharan Africa and East Asia. Most people in these regions become infected with the hepatitis B virus during childhood and between 5–10% of the adult population is chronically infected.
High rates of chronic infections are also found in the Amazon and the southern parts of eastern and central Europe. In the Middle East and the Indian subcontinent, an estimated 2–5% of the general population is chronically infected. Less than 1% of the population in western Europe and North America is chronically infected.
Transmission
In highly endemic areas, HBV is most commonly spread from mother to child at birth, or from person to person in early childhood.
Perinatal or early childhood transmission may also account for more than one third of chronic infections in areas of low endemicity, although in those settings, sexual transmission and the use of contaminated needles, especially among injecting drug users, are the major routes of infection.
The hepatitis B virus can survive outside the body for at least seven days. During this time, the virus can still cause infection if it enters the body of a person who is not protected by the vaccine.
The hepatitis B virus is not spread by contaminated food or water, and cannot be spread casually in the workplace.
The incubation period of the hepatitis B virus is 75 days on average, but can vary from 30 to 180 days. The virus may be detected 30 to 60 days after infection and persists for variable periods of time.
Symptoms
Most people do not experience any symptoms during the acute infection phase. However, some people have acute illness with symptoms that last several weeks, including yellowing of the skin and eyes (jaundice), dark urine, extreme fatigue, nausea, vomiting and abdominal pain.
In some people, the hepatitis B virus can also cause a chronic liver infection that can later develop into cirrhosis of the liver or liver cancer.
More than 90% of healthy adults who are infected with the hepatitis B virus will recover and be completely rid of the virus within six months.
Who is at risk for chronic disease?
The likelihood that infection with the hepatitis B virus becomes chronic depends upon the age at which a person becomes infected. Children less than 6 years of age who become infected with the hepatitis B virus are the most likely to develop chronic infections:
- 80–90% of infants infected during the first year of life develop chronic infections;
- 30–50%% of children infected before the age of 6 years develop chronic infections.
In adults:
- <5% of otherwise healthy adults who are infected will develop chronic infection;
- 15–25% of adults who become chronically infected during childhood die from hepatitis B-related liver cancer or cirrhosis.
Diagnosis
It is not possible, on clinical grounds, to differentiate hepatitis B from hepatitis caused by other viral agents and, hence, laboratory confirmation of the diagnosis is essential. A number of blood tests are available to diagnose and monitor people with hepatitis B. They can be used to distinguish acute and chronic infections.
Laboratory diagnosis of hepatitis B infection centres on the detection of the hepatitis B surface antigen HBsAg. WHO recommends that all blood donations are tested for this marker to avoid transmission to recipients.
- Acute HBV infection is characterized by the presence of HBsAg and immunoglobulin M (IgM) antibody to the core antigen, HBcAg. During the initial phase of infection, patients are also seropositive for HBeAg.
- Chronic infection is characterized by the persistence (>6 months) of HBsAg (with or without concurrent HBeAg). Persistence of HBsAg is the principal marker of risk for developing chronic liver disease and hepatocellullar carcinoma (HCC) later in life.
- The presence of HBeAg indicates that the blood and body fluids of the infected individual are highly contagious
Treatment
There is no specific treatment for acute hepatitis B. Care is aimed at maintaining comfort and adequate nutritional balance, including replacement of fluids that are lost from vomiting and diarrhoea.
Some people with chronic hepatitis B can be treated with drugs, including interferon and antiviral agents. Treatment can slow the progression of cirrhosis, reduce incidence of HCC and improve long term survival. Treatment, however, is not readily accessible in many resource-constrained settings.
Liver cancer is almost always fatal and often develops in people at an age when they are most productive and have family responsibilities. In developing countries, most people with liver cancer die within months of diagnosis. In high-income countries, surgery and chemotherapy can prolong life for up to a few years.
People with cirrhosis are sometimes given liver transplants, with varying success.
Prevention
The hepatitis B vaccine is the mainstay of hepatitis B prevention. WHO recommends that all infants receive the hepatitis B vaccine as soon as possible after birth, preferably within 24 hours.
The birth dose should be followed by 2 or 3 doses to complete the primary series. In most cases, 1 of the following 2 options is considered appropriate:
- a 3-dose schedule of hepatitis B vaccine, with the first dose (monovalent) being given at birth and the second and third (monovalent or combined vaccine) given at the same time as the first and third doses of DTP vaccine; or
- 4 doses, where a monovalent birth dose is followed by 3 monovalent or combined vaccine doses, usually given with other routine infant vaccines.
The complete vaccine series induces protective antibody levels in more than 95% of infants, children and young adults. Protection lasts at least 20 years and is possibly lifelong.
All children and adolescents younger than 18 years old and not previously vaccinated should receive the vaccine if they live in countries where there is low or intermediate endemicity. In those settings it is possible that more people in high risk groups may acquire the infection and they should also be vaccinated. They include:
- people who frequently require blood or blood products, dialysis patients, recipients of solid organ transplantations;
- people interned in prisons;
- injecting drug users;
- household and sexual contacts of people with chronic HBV infection;
- people with multiple sexual partners, as well as health-care workers and others who may be exposed to blood and blood products through their work; and
- travellers who have not completed their hepatitis B vaccination series should be offered the vaccine before leaving for endemic areas.
The vaccine has an excellent record of safety and effectiveness. Since 1982, over one billion doses of hepatitis B vaccine have been used worldwide. In many countries, where 8–15% of children used to become chronically infected with the hepatitis B virus, vaccination has reduced the rate of chronic infection to less than 1% among immunized children.
As of July 2011, 179 Member States vaccinate infants against hepatitis B as part of their vaccination schedules. This is a major increase compared with 31 countries in 1992, the year that the World Health Assembly passed a resolution to recommend global vaccination against hepatitis B. Furthermore, as of July 2011, 93 Member States have introduced the hepatitis B birth dose.
In addition, implementation of blood safety strategies, including quality-assured screening of all donated blood and blood components used for transfusion can prevent transmission of HBV. Safe injection – unnecessary as well as unsafe injections – practices can protect against HBV transmission. Furthermore, safer sex practices, including minimizing the number of partners and using barrier protective measures (condoms), protect against transmission.
WHO response
WHO is working in the following areas to prevent and control viral hepatitis:
- raising awareness, promoting partnerships and mobilizing resources;
- formulating evidence-based policy and data for action;
- preventing of transmission; and
- executing screening, care and treatment.
WHO also organizes World Hepatitis Day on July 28 every year to increase awareness and understanding of viral hepatitis.
Cabergoline therapy for cushing disease throughout pregnancy
CABERGOLINE
Obstet Gynecol. 2013 Aug;122(2 Pt 2):485-7. doi: 10.1097/AOG.0b013e31829e398a.
http://www.ncbi.nlm.nih.gov/pubmed/23884269
.
Woo I, Ehsanipoor RM.
Source
Department of Gynecology and Obstetrics and Division of Maternal-Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Abstract
BACKGROUND:
Cushing disease during pregnancy is rare and is associated with significant maternal and fetal morbidity and mortality. Transsphenoidal pituitary surgery is the first-line therapy; however, in cases of failed surgery or in patients who are not surgical candidates, medical therapy has been used to control symptoms.
CASE:
A 29-year-old woman with Cushing disease and a noncurative transsphenoidal pituitary surgery was successfully treated with cabergoline, a dopamine agonist. After approximately 1 year of therapy, she became pregnant. She was maintained on high-dose cabergoline throughout her pregnancy and had an uncomplicated antenatal course. She went into spontaneous labor at 38 weeks of gestation and delivered a healthy female neonate.
CONCLUSION:
Cabergoline can be used to manage Cushing disease successfully during pregnancy with an opportunity for a favorable outcome.
Cabergoline (brand names Dostinex and Cabaser), an ergot derivative, is a potent dopamine receptor agonist on D2 receptors. In vitro, rat studies show cabergoline has a direct inhibitory effect on pituitary lactotroph (prolactin) cells.[1] It is frequently used as a first-line agent in the management of prolactinomas due to higher affinity for D2 receptor sites, less severe side effects, and more convenient dosing schedule than the older bromocriptine.
History
Cabergoline was invented by scientists working for the Italian drug company Farmitalia-Carlo Erba SpA in Milan in 1981/82,[2] who were experimenting with semisynthetic derivatives of the ergot alkaloids. Farmitalia-Carlo Erba was acquired by Pharmacia in 1992, which in turn was acquired by Pfizer in 2002. The drug was approved by the FDA on December 23, 1996. It went generic in late 2005 following US patent expiration.
Intellectual property
Farmitalia filed a patent application for Cabergoline in 1982, and U.S. Patent 4,526,892 issued in July 1985.
Pharmacology
Although cabergoline is commonly described principally as a dopamine D2 receptor agonist, it also possesses significant affinity for the D3, D4, 5-HT1A, 5-HT2A, 5-HT2B, 5-HT2C, α2B– receptors, and moderate/low affinity for the D1 and 5-HT7 receptors. Cabergoline functions as an agonist at all of these receptors except for 5-HT7 and α2B–, where it acts as an antagonist.[3]
Following a single oral dose, resorption of cabergoline from the gastrointestinal (GI) tract is highly variable, typically occurring within 0.5 to 4 hours. Ingestion with food does not alter its absorption rate. Human bioavailability has not been determined since the drug is intended for oral use only. In mice and rats the absolute bioavailability has been determined to be 30 and 63 percent, respectively. Cabergoline is rapidly and extensively metabolized in the liver and excreted in bile and to a lesser extent in urine. All metabolites are less active than the parental drug or inactive altogether. The human elimination half-life is estimated to be 63 to 68 hours in patients with Parkinson’s disease and 79 to 115 hours in patients with pituitary tumors. Average elimination half-life is 80 hours.
The therapeutic effect in treatment of hyperprolactinemia will typically persist for at least 4 weeks after cessation of treatment.
Mechanism of action
Cabergoline is a long-acting dopamine D2 receptor agonist and in vitro rat studies show a direct inhibitory effect on the prolactin secretion in the pituitary’s lactotroph cells. Cabergoline decreased serum prolactin levels in reserpinized rats.
Receptor binding studies indicate a low affinity for dopamine D1 receptors, α1-adrenergic receptors, and α2-adrenergic receptors.[1]
- 1 Dostinex at www.rxlist.com”. Retrieved 2007-04-27.
- 2 US Patent 4526892 – Dimethylaminoalkyl-3-(ergoline-8′.beta.carbonyl)-ureas
- 3 Sharif NA, McLaughlin MA, Kelly CR, Katoli P, Drace C, Husain S, Crosson C, Toris C, Zhan GL, Camras C (March 2009). “Cabergoline: Pharmacology, ocular hypotensive studies in multiple species, and aqueous humor dynamic modulation in the Cynomolgus monkey eyes”. Experimental Eye Research 88 (3): 386–97. doi:10.1016/j.exer.2008.10.003. PMID 18992242.
- 4 National Institute ofMental Health. PDSD Ki Database (Internet) [cited 2013 Jul 24]. ChapelHill (NC): University of North Carolina. 1998-2013. Available from: http://pdsp.med.unc.edu/pdsp.php
- 5 Sayyah-Melli, M; Tehrani-Gadim, S; Dastranj-Tabrizi, A; Gatrehsamani, F; Morteza, G; Ouladesahebmadarek, E; Farzadi, L; Kazemi-Shishvan, M (2009). “Comparison of the effect of gonadotropin-releasing hormone agonist and dopamine receptor agonist on uterine myoma growth. Histologic, sonographic, and intra-operative changes”. Saudi medical journal 30 (8): 1024–33. PMID 19668882. edit
6 Sankaran, S.; Manyonda, I. (2008). “Medical management of fibroids”. Best Practice & Research Clinical Obstetrics & Gynaecology 22 (4): 655. doi:10.1016/j.bpobgyn.2008.03.001. PMID 18468953. edit http://www.britishfibroidtrust.org.uk/journals/bft_Sankaran.pdf
CUSHING DISEASE VIDEO
BEST WAYS TO COLON CLEANING
colon cleaning
First in Class Once-Daily Dual Bronchodilator Ultibro® Breezhaler® (QVA149) Gains Positive CHMP Opinion for the Treatment of COPD
The developer: Novartis, Vectura
Peak projections: $2 billion-$5 billion
TOKYO, July 27, 2013 /CNW/ –
- QVA149 (indacaterol/glycopyrronium) is the first once-daily fixed-dose combination of both a LABA and a LAMA bronchodilator to gain positive CHMP opinion
- Pivotal Phase III IGNITE data showed QVA149 significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standard of care[1]
- QVA149 demonstrated significantly reduced rates of COPD exacerbations and improved health-related quality of life compared to open-label tiotropium 18 mcg and glycopyrronium 50 mcg[2],[3]
Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information released by Novartis that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for approval of once-daily Ultibro® Breezhaler®(indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was developed under the name of QVA149.
QVA149 is an investigational fixed dose combination of two bronchodilators, indacaterol, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium, a long-acting muscarinic antagonist (LAMA).http://www.newswire.ca/en/story/1203847/first-in-class-once-daily-dual-bronchodilator-ultibro-breezhaler-qva149-gains-positive-chmp-opinion-for-the-treatment-of-copd
QVA149 is an inhaled fixed dose combination product for the treatment of COPD, an irreversible and chronic obstruction of the airways. The product combinesNVA237, the long acting muscarinic antagonist (LAMA) licensed to Novartis by Sosei in 2005, together with Novartis’ long acting beta agonist (LABA), indacaterol, now approved in more than 80 countries, including EU, Japan and the USA.
Both NVA237 and indacaterol are once-daily bronchodilators but act on different receptors in the lung thereby offering the potential in combination to provide additional patient benefit.
Phase III studies (IGNITE: Indacaterol and GlycopyrroNium bromide clInical sTudiEs) for QVA149 is one of the largest international patient registration programs in COPD comprising 10 studies and including more than 7,000 subjects across 42 countries. Up to date, Novartis announced positive results of five Phase III studies: SHINE, BRIGHT, ENLIGHTEN, ILLUMINATE and SPARK. IGNITE data demonstrated the efficacy of QVA149 and showed a superior effect on lung function and patient-reported outcomes versus comparators.
>> More
QVA149 was filed for approval in Europe in October, and in Japan in November 2012. The US filing is expected at the end of 2014.
About COPD
COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. Symptoms include chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of lung function. Worldwide, COPD is estimated to affect a total of 210 million people and is projected to become the third leading cause of death by 2020.
Market Overview
COPD is a large and fast expanding market which is estimated to be worth around $9 billion (2008) and is expected to reach $14 billion by 2014 as a result of better recognition of the disease and improved treatment options.
indacaterol
glycoprronium
US OK for Forest/Pierre Fabre antidepressant fetzima, levomilnacipran
levomilnacipran
The US Food and Drug Administration has approved Forest Laboratories and Pierre Fabre’s Fetzima for major depressive disorder.
Fetzima (levomilnacipran extended-release), a once-daily serotonin and norepinephrine reuptake inhibitor, has been given the green light based on Phase III studies of adults with MDD and statistically significant and clinically meaningful improvement in depressive symptoms across three doses (40, 80, and 120 mg).
read all at
http://www.pharmatimes.com/Article/13-07-26/US_OK_for_Forest_Pierre_Fabre_antidepressant.aspx
Levomilnacipran (F2695) is an antidepressant currently under development by Forest Laboratories for the treatment of depression in the United States and Canada.[1][2][3] As of 2009 it is in phase III clinical trials.[4] Levomilnacipran is an active enantiomer of milnacipran and therefore has similar effects and pharmacology, acting as a serotonin-norepinephrine reuptake inhibitor.[2][5] On 20 January 2011, Forest and Pierre Fabre Medicament announced that levomilnacipran was no better than placebo in a late-stage clinical trial. Two other late-stage trials will be finished in mid-2011.
References
- “Future Treatments for Depression, Anxiety, Sleep Disorders, Psychosis, and ADHD — Neurotransmitter.net”.
- “Pierre Fabre Medicament and Forest Laboratories to Collaborate on Development and Commercialization of F2695 for Depression – FierceBiotech”.
- “News: Forest Buys CNS Disease-Related Drug for $75M Upfront.”.
- “Search of: F2695 – List Results – ClinicalTrials.gov”.
- Deprez D, Chassard D, Baille P, Mignot A, Ung HL, Puozzo C (1998). “Which bioequivalence study for a racemic drug? Application to milnacipran”. European Journal of Drug Metabolism and Pharmacokinetics 23 (2): 166–71. PMID 9725476.
New Drug Approvals 