Germany's Merck Gets Chinese Cancer Drug

 

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

BY WORLD DRUG TRACKER

Blocking Biosimilars

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.

http://www.dddmag.com/articles/2013/06/blocking-biosimilars

BY WORLD DRUG TRACKER

Targeting Pol I to Selectively Activate p53 and Kill Cancer Cells

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. http://www.dddmag.com/articles/2013/06/targeting-pol-i-selectively-activate-p53-and-kill-cancer-cells?et_cid=3304624&et_rid=523035093&type=cta FULL STORY

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

Coenzyme Q10 2-[(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-decamethyltetraconta-2,6,10,14,18,22,26,30,34,38-decaenyl]-5, 6-dimethoxy-3-methylcyclohexa-2,5-diene-1,4-dione

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.

Endo Pharma gets CTL from FDA relating to testosterone drug Aveed

Testosterone undecanoate

Testosterone undecanoate or testosterone undecylate is an ester of testosterone. This hormone is used in androgen replacement therapy primarily for the treatment of male hypogonadism, and is currently under research for use as a male contraceptive. It is sold and distributed under the brand names Andriol, Undestor, Nebido, Pantestone, Restandol, Cernos Depot and Nebido-R and Reandron 1000 ref 1

1. Köhn, FM; Schill, WB (Nov 2003). "A new oral testosterone undecanoate formulation.". World J Urol 21 (5): 311–5. doi:10.1007/s00345-003-0372-x. PMID 14579074. 

• testosterone undecanoate at the US National Library of Medicine Medical Subject Headings (MeSH)

http://www.bioportfolio.com/news/article/1484561/Endo-Pharma-gets-CTL-from-FDA-relating-to-testosterone-drug-Aveed.html


USA-based Endo Health Solutions (Nasdaq: ENDP) says that the US Food and Drug Administration has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for subsidiary Endo Pharmaceuticals' long-acting testosterone undecanoate injection, Aveed, for men diagnosed with hypogonadism.
The complete response letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS). Specifically, the FDA has requested that the REMS include a Medication Guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions

read all at
http://www.thepharmaletter.com/file/122512/endo-pharma-gets-ctl-from-fda-relating-to-testosterone-drug-aveed.html

5 Signs You’ll Get Cancer

 

read all at

http://www.newsmaxhealth.com/MKTNews/Brownstein-cancer-video-documentary/2013/02/11/id/489887?promo_code=13945-1


by Dr Anthony

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.

 

ARTEMETHER, THE ANTIMALARIAL

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 malaria. World 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 Administration. Zambia 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/

Fast flu mapping without the sequencing

Fast flu mapping without the sequencing
	New protein-based approach could build evolutionary trees faster than sequencing

http://www.rsc.org/chemistryworld/2013/05/fast-flu-mapping-protein-mass-spec

Malaria breakthrough triggers hope for new vaccine

Malaria breakthrough triggers hope for new vaccine 

Scientists in Scotland say they have found a link to various strains of a malaria parasite, potentially paving the way for the next-generation malaria drug or vaccine development. 


http://www.pharmaceutical-technology.com/news/newsmalaria-breakthrough-triggers-hope-for-new-vaccine?WT.mc_id=DN_News

Japanese researchers have created a supramolecule that binds to cyanide ions in a similar way to the blood protein haemoglobin. This could pave the way for faster, more effective cyanide antidotes.

The supramolecule mimics the structure of haemoglobin (below) with iron(III) at it's centre
CREDIT© Wiley-VCH


http://www.rsc.org/chemistryworld/2013/05/haemoglobin-mimic-mops-cyanide-poisoning

DRUGS-Using FTIR and NIR spectroscopy in process control

http://www.manufacturingchemist.com/technical/article_page/Using_FTIR_and_NIR_spectroscopy_in_process_control/88634




BY WORLD DRUG TRACKER
DR ANTHONY CRASTO

New Muscular Dystrophy Drugs Offer Hope

New Muscular Dystrophy Drugs Offer Hope

Wall Street Journal

A drug called ataluren is in phase 3 testing, after showing mixed results in earlier studies. Its maker, PTC Therapeutics Inc., declined to comment because it has filed to go public. Pfizer Inc. says it is in phase 1 testing of an antibody that aims to ...


BY WORLD DRUG TRACKER
DR ANTHONY MELVIN CRASTO

GlaxoSmithKline recently announced data from a phase III trial its oncology drug, Votrient (pazopanib). This trial evaluated the use of Votrient as maintenance therapy in women suffering from epithelial ovarian, fallopian tube or primary peritoneal cancer,

Glaxo Reports Votrient Data - Analyst Blog

NASDAQ

GlaxoSmithKline  recently announced data from a phase III trial (n = 940) evaluating its oncology drug, Votrient (pazopanib). The randomized, double-blind, placebo-controlled phase III trial evaluated the use of Votrient as maintenance therapy in women suffering from epithelial ovarian, fallopian tube or primary peritoneal cancer,

http://www.nasdaq.com/article/glaxo-reports-votrient-data-analyst-blog-cm250408


BY WORLD DRUG TRACKER
DR ANTHONY MELVIN CRASTO

Analysis Revealed that Glaxo Drugs Can Prolong Lives of Ovarian Cancer Patients up to 17 Months

Analysis Revealed that Glaxo Drugs Can Prolong Lives of Ovarian Cancer Patients up to 17 Months

Analysis Revealed that Glaxo Drugs Can Prolong Lives of Ovarian Cancer ... 
Headlines & Global NewsThe researchers conducted a large-scale Phase 3 trial on women with advanced ovarian cancer. The test was successful as it prolonged the lives of the patients without getting their disease worse for an average of 5.6 months. The American Society ... 

http://www.hngn.com/articles/4251/20130601/analysis-revealed-glaxo-drugs-prolong-lives-ovarian-cancer-patients-up.htm

According to the study presented last Saturday at the annual meeting of the American Society of Clinical Oncology in Chicago, the oral drug Votrient- with generic name pazopanib formulated to block tumor growth- may be used as a maintenance drug by ovarian cancer patients after the surgery and chemotherapy

Phase 3 DECISION Trial Investigating the Use of Nexavar® (sorafenib)

Phase 3 DECISION Trial Investigating the Use of Nexavar® (sorafenib ...Sacramento BeeThe Phase 3 DECISION data will form the basis for regulatory submissions of sorafenib for the treatment of RAI-refractory differentiated thyroid cancer. Submission of a supplemental New Drug Application (sNDA) in the United States is planned for mid ...

http://www.sacbee.com/2013/06/02/5464658/phase-3-decision-trial-investigating.html

Japan launches $100m initiative to develop drugs for poorest nations

 http://www.pharmatimes.com/Article/13-05-31/Japan_launches_100m_initiative_to_develop_drugs_for_poorest_nations.aspx

New Drug from UTSW Could Offer Prostate Cancer Treatment

New Drug from UTSW Could Offer Prostate Cancer Treatment
D Healthcare Daily
Raj hopes the drug that has been tested in mouse and human tissue will lead to new treatment options and increased longevity for men diagnosed with prostate cancer. Additional testing is needed before the drug can be studied in Phase 1 clinical trials ...
 
http://healthcare.dmagazine.com/2013/05/29/new-drug-from-utsw-offers-possible-prostate-cancer-treatment/