Showing posts with label New Drugs. Show all posts
Showing posts with label New Drugs. Show all posts

Wednesday 12 June 2013

Roche's RoActemra gets EU OK for rare child arthritis



The European Medicines Agency has expanded approval for Roche's RoActemra to cover the treatment of children with polyarticular juvenile idiopathic arthritis.
The regulator has decreed that RoActemra (tocilizumab) can be used to treat patients two years of age and older who have not responded adequately to treatment with methotrexate. The drug can be given alone or in combination with MTX.
volleyball

Tocilizumab(INN, or atlizumab, developed by Hoffmann–La Roche and Chugai and sold under the trade names Actemra and RoActemra) is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of RA in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such asautoimmune diseasesmultiple myeloma and prostate cancer.









 

Will nanorods be the next big male contraceptive idea?

News item thumbnail


Successful experiments on mice bode well for a future human contraceptive - if men can stomach the injections
Researchers in China have discovered a new method of male contraception: a quick injection of gold nanorods into the testes, followed by a 10 minute dose of infrared light. The procedure has only been demonstrated in mice, but the researchers believe it could be used for dogs and cats – and even humans.
Pet contraception is considered an important topic, given the four million unwanted dogs and cats that are thought to be put down every year in the US alone. Many vets routinely sterilise pets, but since surgery requires time and expertise scientists have been looking for cheaper, simpler alternatives.
http://www.rsc.org/chemistryworld/2013/06/gold-nanorods-male-contraceptive


nanorods
Functionalising the nanorods with methoxy poly(ethylene glycol) enables them to be used for contraception or even sterilisation © ACS

New Fluzone Quadrivalent Four-Strain Influenza Vaccine from Sanofi Pasteur Now Licensed By FDA for Broad Age Range of Children and Adults


 
A 5cc vial of Fluzone
June 10, 2013 – Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for licensure of its four-strain influenza vaccine, Fluzone Quadrivalent vaccine. Fluzone Quadrivalent vaccine is the newest addition to the Fluzone family of influenza vaccines. Like Sanofi Pasteur’s Fluzone vaccine, which is administered to more than 50 million people in the U.S. each year, Fluzone Quadrivalent vaccine is licensed for use in children six months of age and older, adolescents, and adults.
http://www.drugs.com/newdrugs/new-fluzone-quadrivalent-four-strain-influenza-vaccine-sanofi-pasteur-now-licensed-fda-broad-age-3810.html




H1N1 virus
Influenza (Flu)

90Y-Epratuzumab Study Shows Improvement of Therapy Results Following R-CHOP

 


June 10, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported that adding two doses of epratuzumab labeled with the radioisotope, yttrium-90 (90Y), to a combination of rituximab and CHOP chemotherapy (R-CHOP), the standard of care for patients with diffuse large B-cell lymphoma (DLBCL), appeared to improve elderly patients' responses to treatment.

read all at
http://www.drugs.com/clinical_trials/90y-epratuzumab-study-shows-improvement-therapy-results-following-r-chop-15714.html 




by
WORLD DRUG TRACKER
DR ANTHONY

Tuesday 11 June 2013

Germany's Merck Gets Chinese Cancer Drug

Photo shows a chemist at Beigene’s lab in Beijing.
 
A chemist works in BeiGene’s labs in Beijing.
Credit: Beigene

 

Germany's Merck Gets Chinese Cancer Drug

Pharmaceutical R&D: Deal signals growing Western confidence in Chinese inventions.
Merck Serono will pay up to $233 million to the Beijing-based drug discovery firm BeiGene for marketing rights outside China to a cancer drug candidate. BeiGene says its compound may be effective against melanoma, colorectal cancer, and other forms of the disease. Human trials of the drug are expected to begin next year.
The deal marks the second time in less than two years that a multinational company has acquired rights to a drug invented in China. In December 2011, Shanghai-based Hutchison MediPharma agreed to license to AstraZeneca the global rights to volitinib, a tyrosine kinase inhibitor being developed as a cancer treatment.


http://cen.acs.org/articles/91/i23/Germanys-Merck-Chinese-Cancer-Drug.html

Infinity Pharmaceuticals And IPI-145: ASCO 2013 Highlights


Infinity Pharmaceuticals And IPI-145: ASCO 2013 Highlights
Seeking Alpha

In June 2012, Infinity suffered a significant writedown when its cancer drug, saridegib proved ineffective in a Phase II clinical trial. The company restructured financing deals with Takeda Pharmaceutical Company, Purdue Pharmaceutical Products, and ...



http://seekingalpha.com/article/1491062-infinity-pharmaceuticals-and-ipi-145-asco-2013-highlights?source=google_news
Interactive 3D Graphics course (credit: Udacity)



BY WORLD DRUG TRACKER

Blocking Biosimilars


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Blocking Biosimilars 
As the U.S. Food and Drug Administration (FDA) continues to finalize regulations to establish a pathway for approving biopharmaceutical or biosimilar drugs, leading branded drug manufacturers are looking ahead and lobbying state legislatures to enact laws that would limit the substitution of biogenerics for brand-name drugs. Currently, pharmacists in most states can substitute lower-cost generics for branded chemical or small-molecule drugs without such approval.



BY WORLD DRUG TRACKER

Targeting Pol I to Selectively Activate p53 and Kill Cancer Cells

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Targeting Pol I to Selectively Activate p53 and Kill Cancer Cells

Cancer is a disease of dysregulated cellular growth and signaling characterized by the loss or gain of function-through mutation or epigenetic change-of important regulatory proteins and cellular processes. Foremost among these is the tumor suppressor protein known as p53.


Monday 10 June 2013

Coenzyme Q10-oral supplements of coenzyme Q10 can benefit patients suffering from heart disease is of increasing appeal


Coenzyme Q10 (ubiquinone-10, CoQ10, CoQ, Q10 or simply Q) is aubiquinone containing 10 isoprenoid units. First discovered in 1957 by Crane et al. [1], its chemical structure was determined by Karl Folkers [2], who later won the Priestley medal from the American Chemical Society. This oil-soluble, vitamin-like micronutrient forms part of the electron transport chain which, in the process of aerobic respiration, generates 95% of the human body's energy asATP [3].
CoQ, or Q10 is a 1,4-benzoquinone, where Q refers to the quinone chemical group, and 10 refers to the number of isoprenylchemical subunits in its tail.
This oil-soluble, vitamin-like substance is present in most eukaryotic cells, primarily in the mitochondria. It is a component of the electron transport chain and participates in aerobic cellular respiration, generating energy in the form of ATP. Ninety-five percent of the human body’s energy is generated this way. Therefore, those organs with the highest energy requirements—such as the heart, liver and kidney—have the highest CoQ10concentrations. There are three redox states of CoQ10: fully oxidized (ubiquinone), semiquinone (ubisemiquinone), and fully reduced (ubiquinol). The capacity of this molecule to exist in a completely oxidized form and a completely reduced form enables it to perform its functions in the electron transport chain and as an antioxidant respectively.
Coenzyme Q10 is synthesized de novo by every cell in the body, but levels decrease with age, in several clinical disorders, and in patients administered certain drugs such as hydroxymethylglutaryl-CoA reductase inhibitors (commonly known as statins). With cardiovascular disease being a leading cause of death in the West, evidence that oral supplements of coenzyme Q10 can benefit patients suffering from heart disease is of increasing appeal. Evidence is also accumulating for its effective treatment of other ailments including mitochondrial disorders and neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Huntington's disease and Parkinson's disease.
Coenzyme Q10 is one of the best-selling dietary supplements worldwide, available over the counter from health food shops and pharmacies. Its popularity may be due to the wide-ranging claims made for its effectiveness in a myriad of human health issues: it is marketed as an energy booster; a periodontal health promoter; an agent for maintaining normal blood-cholesterol levels; an enhancer of cognitive function; a remedy for hypertension, migraine headaches, radiation injury and cancer; and a superdrug capable of delaying or even reversing the effects of aging. However, perusal of the scientific literature reveals that, while data supporting some claims are forthcoming (such as in the case of heart disease and mitochondrial function), coenzyme Q10 is neither panacea nor elixir [4,5].

References

  1. Crane, F.L., Hatefi, Y., Lester, R.L. and Widmer, C. (1957) Isolation of a quinone from beef heart mitochondria. Biochim. Biophys. Acta 25, 220–221.
  2. Wolf, D.E., Hoffman, C.H., Trenner, N.R., Arison, B.H., Shunk, C.H., Linn, B.O., McPherson, J.F. and Folkers, K. (1958) Coenzyme Q. I. Structure studies on the coenzyme Q group. J.Am. Chem. Soc. 80, 4752.
  3. Ernster, L. and Dallner, G. (1995) Biochemical, physiological and medical aspects of ubiquinone function. Biochim. Biophys.Acta 1271, 195–204.
  4. Watts, T.L. (1995), Coenzyme Q10 and periodontal treatment: is there any beneficial effect? Br. Dent. J. 178, 209–213.
  5. European Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies (2010), Scientific Opinion on the substantiation of health claims related to coenzyme Q10 and contribution to normal energy-yielding metabolism (ID 1508, 1512, 1720, 1912, 4668), maintenance of normal blood pressure (ID 1509, 1721, 1911), protection of DNA, proteins and lipids from oxidative damage (ID 1510), contribution to normal cognitive function (ID 1511), maintenance of normal blood cholesterol concentrations (ID 1721) and increase in endurance capacity and/or endurance performance (ID 1913) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA J. 8, 1793–1819.

Sunday 9 June 2013

5 Signs You’ll Get Cancer

Regeneron, Bayer Report Positive Phase 3 Results for Eylea

 
Regeneron and Bayer Report Positive Phase 3 Results for EYLEA® (aflibercept) Injection in Myopic Choroidal Neovascularization (mCNV)
TARRYTOWN, N.Y., June 06, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced positive top-line results for EYLEA® (aflibercept) Injection from the Phase 3 MYRROR study in myopic choroidal neovascularization (mCNV).

http://www.pharmalive.com/regeneron-bayer-report-positive-phase-3-results-for-eylea

 
Aflibercept is a fusion protein approved in the United States for the treatment of wet macular degeneration and metastatic colorectal cancer.
It is an inhibitor of vascular endothelial growth factor. It is designed to bind to VEGF-A,VEGF-B, and placental growth factor (a.k.a PIGF, gene symbol PGF).[3]
Aflibercept is being co-developed by Sanofi-Aventis and Regeneron Pharmaceuticals.
 

Saturday 8 June 2013

Eculizumab proves effective in treating atypical hemolytic uremic syndrome

ECULIZUMAB


A new treatment for patients with atypical hemolytic uremic syndrome ( aHUS) was tested by researchers at Emory University. According to an article published in the New England Journal of Medicine, it seems that eculizumab, a monoclonal antibody, is effective in the management of this life-threatening inflammatory disease.
 
Hemolytic uremic syndrome, which is a thrombotic microangiopathy that causes blood clots in small vessels, is characterized by thrombocytopenia, hemolytic anemia and uremia. It mostly affects children up to 7 years old and is the most common cause of acute renal failure in children. The hemolytic uremic syndrome is often associated with enteric infections (E. coli, Shigella, Salmonella, etc.), but it can occur in other situations such as after certain drugs, tumors, after transplantation, etc..

Read more: http://www.doctortipster.com/14800-eculizumab-proves-effective-in-treating-atypical-hemolytic-uremic-syndrome.html






Site of action of eculizumab. a Complement C5 is split by C5 convertase into C5a and C5b. C5a increases the permeability of blood vessels and attracts inflammatory cells by chemotaxis. C5b binds to other complement components (C6, C7, and C8). The C5b-8 complex is expanded with C9 to form the MAC. MAC binds and permeabilizes bacterial walls (e.g. Neisseria), thereby killing the microorganism. b Eculizumab is a long-acting humanized monoclonal antibody targeted against complement C5. It inhibits the cleavage of C5 into C5a and C5b and hence inhibits deployment of the terminal complement system including the formation of MAC








Site of action of eculizumab. a Complement C5 is split by C5 convertase into C5a and C5b. C5a increases the permeability of blood vessels and attracts inflammatory cells by chemotaxis. C5b binds to other complement components (C6, C7, and C8). The C5b-8 complex is expanded with C9 to form the MAC. MAC binds and permeabilizes bacterial walls (e.g. Neisseria), thereby killing the microorganism. b Eculizumab is a long-acting humanized monoclonal antibody targeted against complement C5. It inhibits the cleavage of C5 into C5a and C5b and hence inhibits deployment of the terminal complement system including the formation of MAC
 

Friday 7 June 2013

Brain makes its own version of Valium, Stanford scientists discover


June 5, 2013

sleeping

Researchers at the Stanford University School of Medicine have found that a naturally occurring protein secreted only in discrete areas of the mammalian brain may act as a Valium-like brake on certain types of epileptic seizures. The protein is known as diazepam binding inhibitor, or DBI. It calms the rhythms of a key brain circuit … more…

read all at

http://www.kurzweilai.net/brain-makes-its-own-version-of-valium-stanford-scientists-discover?utm_source=KurzweilAI+Daily+Newsletter&utm_campaign=2190041b5c-UA-946742-1&utm_medium=email&utm_term=0_6de721fb33-2190041b5c-282116853

by WORLD DRUG TRACKER
DR ANTHONY

New method of mass-producing high-quality DNA molecules



mass_production_dna

A new method of manufacturing short, single-stranded DNA molecules can solve many of the problems associated with current production methods. The new method can be of value to development of drugs consisting of DNA fragments and to DNA nanotechnology research. The novel technique for manufacturing short, single-stranded DNA molecules — or oligonucleotides — has been … more…


http://www.kurzweilai.net/new-method-of-mass-producing-high-quality-dna-molecules?utm_source=KurzweilAI+Daily+Newsletter&utm_campaign=2190041b5c-UA-946742-1&utm_medium=email&utm_term=0_6de721fb33-2190041b5c-282116853

by WORLD DRUG TRACKER
DR ANTHONY

Thursday 6 June 2013

ARTEMETHER, THE ANTIMALARIAL

File:Artemether.svg
Artemether (INN) is an antimalarial for the treatment of multi-drug resistant strains offalciparum malaria. It's combination (co-formulation) with Lumefantrine has first been marketed by Novartis under the brand names Riamet and Coartem. 
Today, this combination therapy is available as generic from several manufacturers.
It is a methyl ether derivative of artemisinin, which is a peroxide lactone isolated from theChinese antimalarial plant, Artemisia annua. It is also known as dihydroartemisinin methyl ether, but its correct chemical nomenclature is (+)-(3-alpha,5a-beta,6-beta,8a-beta, 9-alpha,12-beta,12aR)-decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy-12H-pyrano(4,3-j)-1,2-benzodioxepin. It is a relatively lipophilic and unstable drug.

Artemether is highly effective against the blood schizonts of both malarial parasites P. falciparum and P. vivax. It is available as mono-therapy but usually applied in combination with lumefantrine in clinical treatments of malariaWorld Health Organization guidelines for the treatment of uncomplicated falciparum malaria recommend the use of this artemisinin-based combination therapy, and approved by Swissmedic in December 2008 and recently approved by the United States Food and Drug AdministrationZambia was the first African country to adopt artemether/lumefantrine (commonly called Coartem) as first-line therapy in national malaria treatment guidelines in 2002. Clinical records show that by 2008, the rates of in-patient malaria cases and deaths decreased by 61% and 66%, respectively, compared with the 2001-2002 reference period. In South Africa also the number of malaria-related outpatient cases and hospital admissions to each fall by 99% from 2001 to 2003, and malaria-related deaths decreased by 97% over the same period.[2] The efficacy of the six-dose regimen of Coartem has been confirmed in many different patient populations around the world, consistently achieving 28-day polymerase chain reaction-corrected cure rates of >95% in the evaluable population, rapidly clearing parasitaemia and fever, and demonstrating a significant gametocidal effect, even in areas of widespread parasite resistance to other antimalarials. Coartem is much more effective than quinine, the classical antimalarial. Randomised clinical trial in Uganda shows cure rate of malaria as high as 96% in the Coartem-treated group compared with 64% for the quinine group. For Plasmodium vivax infection, combination withpiperaquine is more effective than Coartem.
PLANT
Artemether has been assigned to category C by the FDA on the basis of animal data which shows an association with fetal-loss and deformity. However, clinical data appears to show that artemether is safe in pregnancy. A meta-analysis of 14 clinical trials that looked at artemether use in a total of 945 pregnant women did not find evidence of harm, and a clinical trial of artemether-lumefantrine designed to look at this question found fewer adverse events in the 138 pregnant women treated with artemther-lumefantrine than women treated with quinine.







DRUG SYNTHESIS PORTALS ON THE NET



DRUG SYNTHEIS PORTALS ON THE NET

READ ALL AT

http://newdrugapprovals.wordpress.com/drug-synthesis/

Tuesday 4 June 2013

DRUGS-Using FTIR and NIR spectroscopy in process control

Improving Compound Extraction Efficiency Novel Method for Skin Tissues Allows Higher-Throughput Sample Processing

First BRCA Targeted Drug Shows Early Promise, BioMarin Jumping to Phase III Trials

Although the aim of the Phase I/II trial was to evaluate the maximum tolerated dose (MTD) and the secondary aim was to evaluate safety and preliminary effects of the drug, the positive clinical results are pushing the company to pursue Phase III ...
http://www.medicaldaily.com/articles/16129/20130603/brca-target-brca-mutation-biomarin-drug-breast-cancer-ovarian-cancer.htm



BY WORLD DRUG TRACKER
DR ANTHONY CRASTO