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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Krill oil is being studied as a natural remedy for high cholesterol
Krill Oil
Krill are shrimp-like crustaceans that are approximately 1 to 6 centimeters long. They live is the ocean, where they feed mainly on phytoplankton. They’re near the bottom of the food chain and are eaten by whales, seals, penguins, squid and fish.
Commercial fishing of krill occurs primarily in the Southern Ocean and the northern Pacific Ocean along the coasts of Canada and Japan. Krill that are caught are used for aquaculture and aquarium feeds, sport fishing bait or they are eaten as food. In Japan, krill that’s caught for food is called okiami.
Krill oil, the oil that’s found naturally in krill, is extracted and sold as a nutritional supplement. It’s sold in some health food stores and online in capsule form.
Krill oil contains omega-3 fatty acids, which is the main reason it’s becoming popular as a nutritional supplement.
Another reason krill oil is becoming popular is because it contains an antioxidant called astaxanthin. The algae that krill eat produces the bright red pigment astaxanthin that gives krill and other crustaceans such as lobster and shrimp their reddish-pink color.
Antioxidants protect our body cells from damage from free radicals, unstable substances that are thought to contribute to certain chronic diseases. Unlike many other antioxidants, astaxanthin crosses the blood-brain barrier, where it could theoretically protect the eye, brain and central nervous system from free radical damage.
The recent popularity of krill oil supplements has raised concerns that it could threaten the population of its predators, including penguins, seals and whales. people use krill oil for the same reasons they use fish oil, flax oil or other omega-3 fatty acids. Unlike fish oil, krill oil doesn’t cause fishy burps or an aftertaste, a common side effect of fish oil. Also, krill oil contains higher amounts of astaxanthin than fish oil. Here are some specific conditions for which it’s used.
1) High Cholesterol
Krill oil is being studied as a natural remedy for high cholesterol. In one study, 120 people were given krill oil, fish oil or a placebo. Krill oil reduced LDL (commonly referred to as “bad”) cholesterol by 34% and increased HDL (“good”) cholesterol by 43.5% compared to the placebo. In comparison, fish oil reduced LDL cholesterol by 4.6% and increased HDL cholesterol by 4.2%. Krill also lowered triglycerides.
2) Premenstrual Syndrome
Preliminary research suggests krill oil may help reduce symptoms of premenstrual syndrome (PMS), however, more research is needed.
Arthritis
A study in the Journal of the American College of Nutrition examined krill oil (300 mg daily) compared to a placebo and found that krill oil was effective at reducing arthritis symptoms and inflammation.
People with allergies to seafood shouldn’t use krill oil. People with bleeding disorders shouldn’t use krill oil unless under the supervision of a qualified health professional.
Side effects of krill oil may include loose stools, diarrhea or indigestion.
people taking blood thinners (anticoagulant or anti-platelet medication), such as aspirin, warfarin (Coumadin), heparin, clopidogrel (Plavix), non-steroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Motrin, Advil), naproxen (Naprosyn, Aleve) should only use krill oil under a physician’s supervision.
Krill oil should also be used with caution by people taking herbs and supplements that are thought to increase the risk of bleeding, such as ginkgo biloba and garlic.
Sources
Bunea R, El Farrah K, Deutsch L.Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. Altern Med Rev. (2004) 9.4: 420-428.
Deutsch L. Evaluation of the effect of Neptune Krill Oil on chronic inflammation and arthritic symptoms. J Am Coll Nutr. (2007) 26.1: 39-48.
MORE INFO
Krill oil is a nutrient from a tiny crustacean (similar to a shrimp) that lives in the icy waters around the Antarctic. It is a rich source of the omega-3 essential fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
The main selling points for krill oil are that its omega-3s are packaged differently from fish oils, in the form of a phospholipid that is easier for the body to absorb. This better absorption rate – up to 60 per cent, according to some manufacturers – means less capsules need to be taken to achieve the desired health benefits.
It is also said to have the added bonus of containing another essential nutrient, choline, as well as an antioxidant, astaxanthin. Astaxanthin is found in sea algae and it’s what gives shrimp, lobster, salmon, krill and other sea-life that feed on algae their rosy color.
Krill oil supplements are also more expensive than fish oils because of the extensive processes undertaken to ensure quality and eco-sustainability. However, many argue that it is better value for money, as you have to take less capsules than if you were taking fish oil.
Rare Undersea Discovery Could Extend Your Life by 10, 20 or 30 Years
Scientists are claiming that they have now isolated unusual ingredients in a rare seaweed discovered by fishermen off the coast of Korea that offer incredible health benefits—including the ability to restore blood pressure to normal levels.
The first is Seanol, an extremely rare seaweed extract from Ecklonia Cava that’s proven to be 100 times more powerful than any land-based antioxidant. That’s because it stays working in your body for 12 hours, compared to land-based antioxidants that work for 30 minutes.
“Its secret is its make-up of special polyphenol antioxidants that are a whopping 40% lipid (fat) soluble,” Dr. Lee explains. “Unlike nearly all land-based antioxidants that are water soluble, Seanol’s protective compounds can get into things like the fatty tissues of your brain and penetrate all three layers of your cells, including the outside, the oil-based cell membranes, and your DNA.”
Indeed, Seanol is so powerful, it’s the only FDA-approved Ecklonia Cava marine-algae extract in existence.
The second ingredient is Calamarine, a deep-sea omega-3 discovery that delivers 85% more DHA omega-3s to your heart, brain, joints, and eyes. It’s known to combat everything from fatigue and poor memory, to vision problems, joint pain, mood swings and depression.
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Ecklonia cava is an edible marine brown alga species found in the ocean off Japan andKorea.
It is used as a herbal remedy in the form of an extract called Seanol, a polyphenolic extract. Another phlorotannin-rich natural agent, Ventol, is also extracted from E. cava.[1]
Phlorotannins, such as fucodiphlorethol G,[2] 7-phloro eckol, 6,6′-bieckol,[3] eckol, 8,8′-bieckol, 8,4″‘-dieckol and phlorofucofuroeckol A can be isolated from Ecklonia cava.[4]
Other components are common sterol derivatives (fucosterol, ergosterol and cholesterol).[3]
- Kang, K.; Hwang, H. J.; Hong, D. H.; Park, Y.; Kim, S. H.; Lee, B. H.; Shin, H. C. (2004). “Antioxidant and antiinflammatory activities of ventol, a phlorotannin-rich natural agent derived from Ecklonia cava, and its effect on proteoglycan degradation in cartilage explant culture”. Research communications in molecular pathology and pharmacology. 115-116: 77–95. PMID 17564307.
- Isolation of a New Phlorotannin, Fucodiphlorethol G, from a Brown Alga Ecklonia cava. Young Min Ham, Jong Seok Baik, Jin Won Hyun and Nam Ho Lee, Bull. Korean Chem. Soc. 2007, Vol. 28, No. 9 1595
- Li, Y.; Qian, Z. J.; Ryu, B.; Lee, S. H.; Kim, M. M.; Kim, S. K. (2009). “Chemical components and its antioxidant properties in vitro: An edible marine brown alga, Ecklonia cava”. Bioorganic & Medicinal Chemistry 17 (5): 1963–1973.doi:10.1016/j.bmc.2009.01.031. PMID 19201199.
- Ahn, M. J.; Yoon, K. D.; Min, S. Y.; Lee, J. S.; Kim, J. H.; Kim, T. G.; Kim, S. H.; Kim, N. G. et al. (2004). “Inhibition of HIV-1 reverse transcriptase and protease by phlorotannins from the brown alga Ecklonia cava”. Biological & pharmaceutical bulletin 27 (4): 544–547.PMID 15056863.
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Calamarine is new super DHA
One of the myths associated with aging is that your body wears out and there is nothing we can do about it. As we get older, we just have to live with chronic disease and the only way to improve the quality of our health and life is to treat the symptoms.
Overwhelmingly, research suggests that this is simply not true. In fact, the American Journal of Clinical Nutrition and Circulation provide documented evidence that consumption of Omega-3 fatty acids from dietary sources and supplements cut the likelihood of an early death.DHA and EPA not only prevent heart disease and sudden death from a sudden heart attack, they lower the risk…
Merck KGaA has entered a collaboration with China-based biotech BeiGene to research a new treatment for cancer.
Merck KGaA has entered a collaboration with China-based biotech BeiGene to research a new treatment for cancer.
The compound, currently known as BeiGene-283, BGB-283 , is a second-generation BRAF inhibitor and is expected to enter clinical development in 2014.
It is designed to work by hindering the action of the BRAF protein, which is thought to play a part in the promotion of cancer cell growth and has been found to be mutated in some cancer patients.
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http://www.pmlive.com/pharma_news/merck_kgaa_to_research_cancer_drug_with_chinese_biotech_480521
A positive genotoxicity result can throw the fate of a promising drug candidate—in which a firm has invested significant time and money—into doubt
A positive genotoxicity result can throw the fate of a promising drug candidate-in which a firm has invested significant time and money-into doubt. The statistical improbability and challenges of bringing a drug to market become paramount.
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BY WORLD DRUG TRACKER
Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
TOLVAPTAN
may 30 2013
- Tolvaptan was discovered by Otsuka in Japan, and its primary results from a global clinical trial involving 1,400 ADPKD patients from 15 countries, which demonstrated a statistically significant reduction in the rate of total kidney volume, were published in New England Journal of Medicine in 2012. It is also currently under a fast track review in the US, following our announcement of FDA accepting to review the application in April 2013.
- ADPKD is a hereditary and often physically and mentally burdensome disease characterized by the development of multiple cysts in the kidneys. ADPKD is often associated with pain, hypertension, decreased kidney function and ultimately, kidney failure that may result in hemodialysis or kidney transplantation.
- There are estimated to be approximately 31,000 ADPKD patients in Japan, and the diagnosed prevalence is estimated to be between 1:1000 and 1:4000 globally.
(Tokyo, Japan, May 30, 2013) – Otsuka Pharmaceutical Co., Ltd. Today announced it filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published in the New England Journal of Medicine in November 2012. The MHLW has designated tolvaptan as an Orphan Drug.http://www.otsuka.co.jp/en/release/2013/0603_02.html
Tolvaptan (INN), also known as OPC-41061, is a selective, competitive vasopressin receptor 2 antagonist used to treat hyponatremia (low blood sodium levels) associated withcongestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone(SIADH). Tolvaptan was approved by the U.S. Food and Drug Administration (FDA) on May 19, 2009, and is sold by Otsuka Pharmaceutical Co. under the trade name Samsca and in India is manufactured & sold by MSN laboratories Ltd. under the trade name Tolvat & Tolsama.
Tolvaptan is also in fast-track clinical trials[2] for polycystic kidney disease. In a 2004 trial, tolvaptan, when administered with traditional diuretics, was noted to increase excretion of excess fluids and improve blood sodium levels in patients with heart failure without producing side effects such as hypotension (low blood pressure) or hypokalemia(decreased blood levels of potassium) and without having an adverse effect on kidney function.[3] In a recently published trial (TEMPO 3:4 ClinicalTrials.gov number, NCT00428948) the study met its primary and secondary end points. Tolvaptan, when given at an average dose of 95 mg per day over a 3-year period, slowed the usual increase in kidney volume by 50% compared to placebo (2.80% per year versus 5.51% per year, respectively, p<0.001) and reduced the decline in kidney function when compared with that of placebo-treated patients by approximately 30% (reciprocal serum creatinine, -2.61 versus -3.81 (mg/mL)-1 per year, p <0.001)[4]
Chemical synthesis:[5] 
- Shoaf S, Elizari M, Wang Z, et al. (2005). “Tolvaptan administration does not affect steady state amiodarone concentrations in patients with cardiac arrhythmias”. J Cardiovasc Pharmacol Ther 10 (3): 165–71. doi:10.1177/107424840501000304. PMID 16211205.
- Otsuka Maryland Research Institute, Inc.
- Gheorghiade M, Gattis W, O’Connor C, et al. (2004). “Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure: a randomized controlled trial”. JAMA 291 (16): 1963–71. doi:10.1001/jama.291.16.1963. PMID 15113814.
- (2012) Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease
- Kondo, K.; Ogawa, H.; Yamashita, H.; Miyamoto, H.; Tanaka, M.; Nakaya, K.; Kitano, K.; Yamamura, Y.; Nakamura, S.; Onogawa, T.; et al.; Bioor. Med. Chem. 1999, 7, 1743.
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350185.htm?source=govdelivery
- Gheorghiade M, Niazi I, Ouyang J et al. (2003). “Vasopressin V2-receptor blockade with tolvaptan in patients with chronic heart failure: results from a double-blind, randomized trial”. Circulation 107 (21): 2690–6. doi:10.1161/01.CIR.0000070422.41439.04.PMID 12742979.
New study reveals Iron supplementation may help Velcade work better
bortezomib
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Bortezomib (INN, originally codenamed PS-341; marketed as Velcade by Millennium Pharmaceuticals) is the first therapeutic proteasome inhibitor to be tested in humans. It is approved in the U.S. for treating relapsed multiple myeloma and mantle cell lymphoma. In multiple myeloma, complete clinical responses have been obtained in patients with otherwise refractory or rapidly advancing disease.
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Bortezomib was originally synthesized in 1995 (MG-341) at a company called Myogenics, which soon changed its name to ProScript. After promising preclinical results, the drug (PS-341) was tested in a small Phase I clinical trial on patients with multiple myeloma cancer. ProScript ran out of money and was bought by Leukosite in May 1999. Leukosite in turn was bought by Millennium Pharmaceuticals in October 1999. At this point in time, the project had low priority amongst other projects at the company. This changed significantly when one of the first volunteers to receive the drug in the clinical trial achieved a complete response and were still alive four years later. At the time this was a remarkable result. Later clinical experimentation indicates the possibility of a complete response in 15% of patients in a similar condition, when treated with bortezomib.
In May 2003, seven years after the initial synthesis, bortezomib (Velcade) was approved in the United States by the Food and Drug Administration (FDA) for use in multiple myeloma, based on the results from the SUMMIT Phase II trial.
Another commercially available bortezomib product – Bortenat (Natco Pharma, India), reportedly contains substantially more active entity than declared, potentially and even more resulting in increase toxicity. Moreover, Bortenat has some other chemical and formulation deviations from the registered ethic product Velcade (Millennium Pharmaceuticals and Janssen-Cilag), with unclear clinical impact.
Pharmacology
Bortezomib bound to the core particle in a yeast proteasome. The bortezomib molecule is in the center colored by atom type (boron = pink, carbon = cyan, nitrogen = blue, oxygen = red), surrounded by the local protein surface. The blue patch is catalytic threonine residue whose activity is blocked by the presence of bortezomib.
Structure
The drug is an N-protected dipeptide and can be written as Pyz-Phe-boroLeu, which stands for pyrazinoic acid, phenylalanine and Leucine with a boronic acid instead of a carboxylic acid. Peptides are written N-terminus to C-terminus, and this convention is used here even though the “C-terminus” is a boronic acid instead of a carboxylic acid.
FDA panel urges looser restrictions on diabetes drug Avandia
june 6 2013,
The controversial diabetes drug Avandia will get a second look from federal regulators this week, nearly two years after its use was severely restricted because of a link to heart problems.
The U.S. Food and Drug Administration has convened a panel of experts to consider an independent review by Duke University researchers of Avandia’s original clinical trial. The expert panel will conclude its sessions on Thursday, and could decide to alter or even lift the tight restrictions now in place regarding the medication’s use.
The Duke scientists did uncover some previously unreported cases of heart complications and deaths, but concluded that these cases did not significantly raise the overall risk of heart disease and the conclusions of the original trial still hold.
The FDA’s reconsideration of Avandia’s safety has prompted stinging criticism from the drug’s detractors, who say the agency is trying to save face following a very public embarrassment over the drug.
“This is a drug that has essentially been off the market in almost the entire world for the last three years. It has been banned in most countries, and is available in the United States under such strict requirements that only 3,000 patients now take it,” said Dr. Steven Nissen, the Cleveland Clinic cardiologist who first led the charge against Avandia. “It’s really about the FDA wanting to clean up its image, not about whether the drug is actually safe or unsafe.”
The FDA has defended its decision to review the Duke re-analysis of the original trial, which was conducted by the drug’s maker, GlaxoSmithKline, under the name Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD).
“Given the public interest in Avandia, the extensive history of the product and the continued uncertainty of risk, the FDA is holding the advisory committee meeting to have a transparent, public discussion of the results of the RECORD readjudication,” FDA spokesperson Morgan Liscinsky said.
Avandia quickly became a blockbuster diabetes drug following its release in 1999, with sales topping $3 billion in 2006.
Nutrient Found in Mediterranean Diet Shown to Promote Natural Cancer Cell Death Cycle
Volumes of well documented scientific studies now provide conclusive evidence that many forms of potentially deadly cancers develop as the result of dietary or lifestyle influences, and can be prevented or even treated with relatively simple modifications and by utilizing a host of natural nutrients. One of the primary methods used by cancer cells to develop and spread is a unique ability to ‘trick’ our innate immune response and avoid elimination through the natural process known as apoptosis.
A research team from the University of Ohio, publishing the results of a study in the Proceedings of the National Academy of Sciences has found that a compound abundant in the Mediterranean diet takes away cancer cells’ ‘superpower’ to escape death. Scientists discovered that by altering a very specific step in gene regulation, this compound essentially re-educates cancer cells to revert back to normal cells that die as scheduled. The compound…
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Mayo Clinic – Ginseng Fights Fatigue in Cancer Patients, Mayo Clinic-Led Study Finds
High doses of the herb American ginseng (Panax quinquefolius) over two months reduced cancer-related fatigue in patients more effectively than a placebo, a Mayo Clinic-led study found. Sixty percent of patients studied had breast cancer. The findings are being presented at the American Society of Clinical Oncology’s annual meeting.
via Mayo Clinic – Ginseng Fights Fatigue in Cancer Patients, Mayo Clinic-Led Study Finds.
New Drug Approvals 