Verona Pharma Plc Peer-Reviewed Paper Suggests RPL554 With Glycopyrrolate, Or Other Muscarinic Receptor Antagonists, Produces Synergistic Bronchodilation

RPL554

Verona Pharma Plc ("Verona Pharma" Or The "Company") Peer-Reviewed ...

Wall Street Journal
Verona Pharma is developing first-in-class drugs to treat respiratory disease, such as COPD, asthma and chronic, severe cough. The Company has three drug programmes, two of which are in Phase II. The lead programme, RPL554, is an innovative dual ...
read all at
http://online.wsj.com/article/PR-CO-20130701-900428.html?mod=googlenews_wsj



RPL-554 (LS-193,855) is a drug which acts as a long-acting inhibitor of the phosphodiesterase enzymes PDE-3 and PDE-4, producing both bronchodilator and antiinflammatory effects.^[1] It is being developed by Verona Pharma as a potential treatment for asthma and hay fever, and is currently in clinical trials.^[2][3]

1.  Boswell-Smith V, Spina D, Oxford AW, Comer MB, Seeds EA, Page CP. The Pharmacology of Two Novel Long-Acting Phosphodiesterase 3/4 Inhibitors, RPL554 (9,10-Dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(N-carbamoyl-2-aminoethyl) -3,4,6,7-tetrahydro-2H-pyrimido(6,1-a)isoquinolin-4-one) and RPL565 (6,7-Dihydro-2-(2,6-diisopropylphenoxy)-9,10-dimethoxy-4H-pyrimido(6,1-a)isoquinolin-4-one). Journal of Pharmacology and Experimental Therapeutics 2006; 318(2):840-848.
2.  Verona Pharma Plc - Lead Drug RPL554
3.  Asthma and hay fever drug tested. BBC News, Wednesday 10 September 2008

Alexion’s Soliris® (eculizumab) Receives Orphan Drug Designation for the Treatment of Neuromyelitis Optica (NMO)

Structure of eculizumab. Eculizumab was engineered to reduce immunogenicity and eliminate effector function. Human IgG2 and IgG4 heavy-chain sequences were combined to form a hybrid constant region that is unable to bind Fc receptors or to activate the complement cascade. Eculizumab exhibits high affinity for human C5, effectively blocking its cleavage and downstream proinflammatory and cell lytic properties. Reprinted from Rother et al with permission.  

Alexion's Soliris® (eculizumab) Receives Orphan Drug Designation for the ...

Fort Mills Times
In a Phase 2 study presented at the 2012 annual meeting of the American Neurological Association (ANA), Soliris treatment was associated with a significant reduction in the frequency of relapses (recurring attacks) in patients with severe, relapsing ...

http://www.fortmilltimes.com/2013/06/27/2789656/alexions-soliris-eculizumab-receives.html


Eculizumab (INN and USAN; trade name Soliris) is a humanized monoclonal antibody that is a first-in-class terminal complement inhibitor and the first therapy approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, progressive, and sometimes life-threatening disease characterized by excessive destruction of red blood cells (hemolysis). It costs £400,000 (US$600,000) per year per patient

Eculizumab also is the first agent approved for the treatment of atypical hemolytic uremic syndrome (aHUS), an ultra-rare genetic disease that causes abnormal blood clots to form in small blood vessels throughout the body, leading to kidney failure, damage to other vital organs and premature death.

In clinical trials in patients with PNH, eculizumab was associated with reductions in chronic hemolysis, thromboembolic events, and transfusion requirements, as well as improvements in PNH symptoms, quality of life, and survival.Clinical trials in patients with aHUS demonstrated inhibition of thrombotic microangiopathy (TMA),the formation of blood clots in small blood vessels throughout the body, including normalization of platelets and lactate dehydrogenase (LDH), as well as maintenance or improvement in renal function.

Eculizumab was discovered and developed by Alexion Pharmaceuticals and is manufactured by Alexion. It was approved by the United States Food and Drug Administration (FDA) on March 16, 2007 for the treatment of PNH, and on September 23, 2011 for the treatment of aHUS. It was approved by the European Medicines Agency for the treatment of PNH on June 20, 2007, and on November 24, 2011 for the treatment of aHUS. Eculizumab is currently being investigated as a potential treatment for other severe, ultra-rare disorders.

Ambrx partners with Zhejiang for breast cancer antibody drug conjugate development

Ambrx has partnered with Zhejiang Medicine for the development and commercialization of ARX788, its antibody drug conjugate (ADC) for breast cancer... Targeting Her2-positive breast cancer, ARX788 is developed by the clinical stage biopharmaceutical company Ambrx as site-specific ADC.

http://contractresearch.pharmaceutical-business-review.com/news/ambrx-partners-with-zhejiang-for-breast-cancer-antibody-drug-conjugate-development-170613

Incyte Drug Jakafi ® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients with Myelofibrosis

ruxolitinib Incyte Drug Jakafi®ruxolitinib Improved Overall Survival in Phase ... Incyte Drug Jakafi®ruxolitinib Improved Overall Survival in Phase III Trial of Patients with Myel. by Business Wirevia The Motley Fool Jun 16th 2013 220AM ... http://www.dailyfinance.com/2013/06/16/incyte-drug-jakafi-ruxolitinib-improved-overall-su/ Ruxolitinib (trade names Jakafi and Jakavi, by Incyte Pharmaceuticals and Novartis) is a drug for the treatment of intermediate or high-risk myelofibrosis, a type of bone marrow cancer. It is also being investigated for the treatment of other types of cancer (such as lymphomas and pancreatic cancer), for polycythemia vera, and for plaque psoriasis. The phase III Controlled Myelofibrosis Study with Oral JAK Inhibitor-I (COMFORT-I) and COMFORT-II trials showed significant benefits by reducing spleen size, relieving debilitating symptoms, and improving overall survival

ABILIFY® Granted Additional Approval as Adjunctive Therapy for the Treatment of Depression in Japan

ABILIFY® Granted Additional Approval as Adjunctive Therapy for the Treatment of Depression in Japan

Otsuka Pharmaceutical Co., Ltd. today obtained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for ABILIFY as the first antsipsychotic drug in Japan to treat...

http://japan.pharmaintellect.com/2013/06/abilify-granted-additional-approval-as.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

Pharma-Execs-2012-Pipeline-Report

 
Just days before this article went to press, FDA approved the first of a new kind of oral enzyme treatment that mediates cellular response, Incyte/Novartis' Jakafi, for a rare bone marrow disease called myelofibrosis. The next JAK inhibitor, Pfizer's toficitinib, could hit the market late next year, meaning a lot of rheumatoid arthritis patients will never again have to sit in a hospital for a couple of hours to get an anti-TNF infusion. Many innovative drugs, long out of the gate, are closing in on the finish line; science is back, and a better understanding of the way genomics shapes disease is bringing about better outcomes, and sometimes faster approvals.

read all at

http://www.pharmexec.com/pharmexec/Deals/Pharm-Execs-2012-Pipeline-Report/ArticleStandard/Article/detail/752361?contextCategoryId=48159

The Design, Development and Scale-Up of Safe Chemical Processes and Operations

2 - 4 October 2013 • Chilworth Global, Princeton, NJ, USA

Dr Vahid Ebadat, Chilworth Technology Inc.

Dr. Swati Umbrajkar

Dr Will Watson, Scientific Update

http://ecampaign.scientificupdate.co.uk/index.php?action=social&c=17c276c8e723eb46aef576537e9d56d0.882

Developing safe processes is of paramount importance to any chemical company. Exothermic chemical reactions in batch and semi- batch processes can result in serious injury to people and plant if they get out of control. Results of thermal runaways include violent loss of containment, possibly explosion and the release of flammable or toxic materials to the environment.
Employers are bound by Health & Safety legislation to ensure the safety of their employees and those outside their employment who might be affected by their activities. Chemical manufacturers must therefore be aware of all potential dangers in their processes and take steps to eliminate them. The best approach is to design safety into the process from the start.
This seminar is designed to enhance the awareness of chemists and engineers regarding hazard issues. Utilizing the expertise of the chemists and chemical engineers at Chilworth Global and Scientific Update, it will consider hazard control of new chemical processes throughout their development cycle: from early development through to full-scale production. Hazards can often be eliminated by appropriate choice of reagent or synthetic route at the R&D stage. Where this is not possible, techniques exist to quantify the hazards so that robust engineering solutions can he applied in production.

Who Should Attend?

• R&D and Process Development Chemists, Chemical Engineers, Managers and anyone whose responsibilities include safety or risk assessment of chemical processes or building safety into chemical process scale-up.

Visit SCIENTIFIC UPDATE website for complete course information.

http://ecampaign.scientificupdate.co.uk/index.php?action=social&c=17c276c8e723eb46aef576537e9d56d0.882

DRUG SCALEUP AND MANUFACTURING INTERNATIONAL BY DR ANTHONY MELVIN CRASTO, WORLD DRUG TRACKER

http://drug-scaleup-and-manufacturing.webnode.com/news/my-website-on-scaleup-of-organic-compounds/

AstraZeneca buys Pearl Therapeutics in $1.15bn deal

AstraZeneca buys Pearl Therapeutics in $1.15bn deal


The UK's second largest drug company, AstraZeneca, has announced that it will buy US based lung disease drug specialist, Pearl Therapeutics, in a deal worth up to $1.15bn (£742m).

 http://www.pharmaceutical-technology.com/news/newsastrazeneca-buys-pearl-therapeutics-in-115bn-deal?WT.mc_id=DN_News














 

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.

http://www.pharmatimes.com/Article/13-06-10/Roche_s_RoActemra_gets_EU_OK_for_rare_child_arthritis.aspx

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 diseases, multiple myeloma and prostate cancer.

 

Will nanorods be the next big male contraceptive idea?

Will nanorods be the next big male contraceptive idea?

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



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





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

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.