Takeda Presents Data from Phase 3 TOURMALINE-MM1 Study for NINLARO® (ixazomib), First and Only Once-Weekly Oral Proteasome Inhibitor Recently Approved for Multiple Myeloma

ORLANDO, Fla.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) today announced results from the TOURMALINE-MM1 trial presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treatment with NINLARO® (ixazomib) capsules is effective in extending progression free survival (PFS) with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma. Buy Kamagra Soft (Sildenafil Citrate) without Rx The TOURMALINE-MM1 trial is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone. NINLARO was recently approved by the U.S. Buy Namenda (Memantine) with no prescription Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Buy Lanoxin (Digoxin) without prescription The approval was based on the Phase 3 TOURMALINE-MM1 data, which were highlighted at today’s ASH press briefing. Buy Inspra with free Rx Ixazomib data will be featured in 18 presentations at this year’s ASH meeting, including an oral presentation on Phase 2 data from an investigational study evaluating the all-oral combination of ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) in newly diagnosed multiple myeloma patients. “The data presented at ASH this year are the first major output from the comprehensive ixazomib clinical trial program, TOURMALINE, demonstrating Takeda’s ongoing commitment to providing effective and convenient treatment options for patients with multiple myeloma,” said Andy Plump, M.D., Ph.D, Takeda Chief Medical and Scientific Officer. Buy Casodex (Bicalutamide) with free Rx “The breadth and depth of the TOURMALINE program allows us to gather important data across a broad range of patients that live with multiple myeloma and to expand on the efficacy and safety profile of our oral proteasome inhibitor, ixazomib. Buy HMB online We will continue this and other important clinical trials and look forward to sharing results over the next few years.” The comprehensive ixazomib clinical development program, TOURMALINE, includes a total of five pivotal trials – four investigating every major multiple myeloma patient population and one in light-chain amyloidosis. Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in Combination with Lenalidomide and Dexamethasone (IRd), Significantly Extends Progression-Free Survival (PFS) for Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): The Phase 3 Tourmaline-MM1 Study (Abstract #727) TOURMALINE-MM1 (n= 722) is the first double-blind, placebo-controlled trial with a proteasome inhibitor and has met the primary endpoint at the first interim analysis. http://medical-questions-answers.blogspot.com Trial results demonstrate a statistically significant (35%) improvement in PFS, with patients treated in the ixazomib arm living for a significantly longer time without their disease worsening compared to patients in the control arm (20.6 months vs. 14.7 months in control group; Hazard Ratio [HR] 0.742; p = 0.012). Overall response rate (ORR) was 78.3% in the ixazomib arm and median duration of response was 20.5 months, vs. 71.5% and 15 months in the control group. Median PFS in high-risk patients (HR 0.543; HR 0.596 in patients with del(17p)) was similar to that in the overall patient population and in standard-risk patients. Adverse events observed with IRd were consistent with reported safety profiles for the individual agents. The most common gr >=3 adverse events included neutropenia, anemia, thrombocytopenia, and pneumonia. Gastrointestinal events included diarrhea, nausea, and vomiting. Peripheral neuropathy (PN) rates were 28% in the IRd arm vs. 21% in the control arm, 35% vs. 21% had rash events, 8% vs. 10% had acute renal failure, and 4% vs. 3% had heart failure. “The TOURMALINE-MM1 trial evaluated ixazomib plus lenalidomide and dexamethasone in some of the most common patient types in the relapsed/refractory multiple myeloma setting who are in urgent need of new treatment options due to the complex nature of this disease. This trial enabled us to gather efficacy and safety data across a large variety of patients such as older patients, patients with moderate renal impairment, light chain disease, and high risk cytogenetics,” said lead investigator and presenter Philippe Moreau, M.D., University of Nantes, France.” The TOURMALINE-MM1 trial is currently ongoing. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes. Takeda has submitted additional review applications for ixazomib to regulatory authorities around the world, including the European Medicines Agency (EMA), based on the TOURMALINE-MM1 data. Randomized Phase 2 Study of the All-Oral Combination of Investigational Proteasome Inhibitor (PI) Ixazomib Plus Cyclophosphamide and Low-Dose Dexamethasone (ICd) in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Who Are Transplant-Ineligible (Abstract #26) Takeda also presented preliminary data from an open-label, multicenter, Phase 2 study that investigates the all-oral triplet combination of ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) as a first line therapy for patients not eligible for transplant. Preliminary data demonstrated comparable activity across treatment arms with a manageable toxicity profile in line with previous ixazomib studies and with manageable myelosuppression. This is the first study to assess ICd for the frontline treatment of multiple myeloma. The Phase 2 study (n = 70) randomized patients receiving ixazomib, low-dose dexamethasone and two different doses of cyclophosphamide 300 mg/m2 (ICd-300, n = 36) or 400 mg/m2 (ICd-400, n = 34), with a mean duration follow-up of 7.0 months in both arms. Preliminary results across treatment arms demonstrated best unconfirmed complete response plus very good partial response (CR+VGPR) of 27% (ICd-300) and 23% (ICd-400), as well as early overall response rates (ORR) of 80% (ICd-300) and 73% (ICd-400). Toxicity was manageable in both the ICd-300 and ICd-400 arms, but toxicity rates appeared higher with ICd-400. Thrombocytopenia events occurred in 5 patients (no gr >=3) in the ICd-300 arm and 4 patients (3 gr >=3) in the ICd-400 arm. Most common adverse events (>15% all patients) included anemia, neutropenia, nausea, PN, diarrhea, vomiting, constipation, and fatigue. Most common gr >=3 adverse events were neutropenia, anemia and pneumonia; no Grade 3 PN was observed. “Research has shown that the combination of a proteasome inhibitor with cyclophosphamide and dexamethasone is active in patients with multiple myeloma. As treatment practices for multiple myeloma can vary across regions, it is important that we gain an understanding of the utility of ixazomib in a number of combination settings,” said lead investigator and presenter Meletios A. Dimopoulos, M.D., National and Kapodistrian University of Athens, School of Medicine. “Preliminary data suggest that this may be a viable all-oral triplet regimen. We are committed to gathering additional data of ixazomib in this investigational setting.” About NINLARO (ixazomib) capsules NINLARO (ixazomib) is the first and only oral proteasome inhibitor approved by the U.S. Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is administered orally, once-weekly on days 1, 8, and 15 of a 28-day treatment cycle. NINLARO is currently under review by the European Medicines Agency (EMA) and was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP). NINLARO also received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014. The TOURMALINE clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing: TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT) TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally. For additional information on the ongoing Phase 3 studies please visit .clinicaltrials.gov. To learn more about NINLARO, please visit .NINLARO.com or call 1-844-N1POINT (1-844-617-6468). Important Safety Information WARNINGS AND PRECAUTIONS Thrombocytopenia has been reported with NINLARO. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle. Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Adjust dosing for severe symptoms. Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed. Peripheral Edema was reported with NINLARO. Monitor for fluid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing as needed. Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Manage rash with supportive care or with dose modification. Hepatotoxicity has been reported with NINLARO. Monitor hepatic enzymes regularly during treatment and adjust dosing as needed Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO. ADVERSE REACTIONS The most common adverse reactions occurring in greater than or equal to 20% of patients treated with NINLARO were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain. SPECIAL POPULATIONS Hepatic Impairment: Reduce the NINLARO starting dose to 3mg in patients with moderate or severe hepatic impairment Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable. Lactation: Advise women to discontinue nursing while on NINLARO. DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers. INDICATION NINLARO (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Please see the accompanying full Prescribing Information for NINLARO. About Multiple Myeloma Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of plasma cells, or myeloma cells, becomes cancerous and multiplies, increasing the number of plasma cells to a higher than normal level. Because plasma cells circulate widely in the body, they have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with more than 26,000 new cases in the U.S. and 114,000 new cases globally per year. About Takeda Located in Osaka, Japan, Takeda (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, .takeda.com.

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FDA Approves Strensiq™ (asfotase alfa) for Treatment of Patients with Perinatal-, Infantile- and Juvenile-Onset Hypophosphatasia (HPP)

CHESHIRE, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. Buy Desyrel (Trazodone) with no Rx (NASDAQ: ALXN) announced today that the U.S. Robaxin (Methocarbamol) with free prescription Food and Drug Administration (FDA) has approved Strensiq™ (asfotase alfa) for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP). Clarinex (Desloratadine) without prescription Strensiq, an innovative enzyme replacement therapy (ERT), is the first therapy approved in the U.S. Gynodiol without prescription for the treatment of patients with HPP, a genetic, chronic, and progressive ultra-rare metabolic disease in which patients experience devastating effects on multiple systems of the body, leading to debilitating or life-threatening complications.1 “The FDA approval of Strensiq brings a highly innovative treatment to patients who, until now, have had no effective therapy to treat this ultra-rare genetic metabolic disease that causes premature death in infants and devastating consequences in those who survive,” said David Hallal, Chief Executive Officer of Alexion. Buy Differin (Adapalene) with free prescription “We are pleased that the label includes a survival benefit in infants, substantial bone healing, and improvements in growth and mobility in patients with HPP who had symptoms prior to the age of 18 and were treated with Strensiq. Buy Food Based Vitamin C online We look forward to rapidly bringing this life-transforming therapy to patients with HPP and their physicians in the United States.” “Asfotase alfa is an important advance for many patients with HPP, their families, and the medical community because it can effectively replace in the skeleton the deficient enzyme called tissue non-specific alkaline phosphatase,” said Michael Whyte, M.D., lead clinical trial investigator and Medical-Scientific Director of the Center for Metabolic Bone Disease and Molecular Research at Shriners Hospital for Children in St. http://doctor-consult.blogspot.com Louis. “Without treatment, many newborns and infants with HPP fail to develop a normal rib cage and die from respiratory failure, and young children with HPP can suffer from rickets and muscle weakness. In clinical studies, 97 percent of severely affected newborns or infants were alive at age 1 year with asfotase alfa treatment compared to 42 percent of historical control patients. Treatment with asfotase alfa, now for up to seven years, often markedly improved overall health. In young children with HPP, now treated for five years with asfotase alfa, significant corrections of the skeletal complications were documented, and all had better mobility and function -- most achieving the normal range for healthy peers. I am more than gratified by this progress.” HPP is characterized by low alkaline phosphatase (ALP) activity and defective bone mineralization that can lead to deformity of bones and other skeletal abnormalities, as well as systemic complications such as profound muscle weakness, seizures, pain, and respiratory failure leading to premature death in infants.1-5 HPP is an ultra-rare disease, which is defined as a disease that affects fewer than 20 patients per one million in the general population.6 “Today is a defining moment for the HPP community, which now has an approved therapy for the first time. It is my hope that patients and their families will benefit from improved awareness of HPP, faster diagnosis, and better outcomes now that there is an approved and effective treatment,” said Deborah Sittig, President and Founder of Soft Bones. Alexion will offer support to patients with HPP through its OneSource™ program. OneSource provides each patient and family with personalized support from a dedicated Alexion nurse case manager, who can help patients understand their insurance benefits, receive reimbursement assistance, and provide education support such as in-home injection training. Through OneSource, patients and families can obtain further information regarding third-party foundations and co-pay assistance programs, which help patients meet out-of-pocket expenses related to the treatment of HPP. For uninsured patients who have no access to insurance, the Alexion Access Foundation, a charitable entity, provides Strensiq free of charge for patients. Patients, caregivers, and healthcare providers in the U.S. can now call 1-888-765-4747 to speak with a OneSource nurse case manager. Alexion will now begin serving patients with HPP in the U.S., with Strensiq becoming available commercially by October 27, 2015. The FDA approved Strensiq under Priority Review, and had granted Breakthrough Therapy designation for Strensiq. With this approval, the FDA also issued a Rare Pediatric Disease Priority Review Voucher, which confers priority review to a subsequent drug application that would not otherwise qualify for priority review. The rare pediatric disease review voucher program is designed to encourage development of new drugs and biologics for the prevention or treatment of rare pediatric diseases. Strensiq is also approved in the European Union, Japan, and Canada. Clinical Data7 The approval of Strensiq in the U.S. was based on data from four clinical trials and supporting extension trials comprising patients with perinatal-, infantile- and juvenile-onset HPP who received treatment with Strensiq for up to 6.5 years. In patients (ages 1 day to 6.5 years) with perinatal/infantile-onset HPP, treatment with Strensiq resulted in a significant survival benefit compared to historical control patients with similar clinical characteristics. At week 48, the Kaplan-Meier estimate of overall survival was 97 percent for treated patients (n=68) compared to 42 percent for historical control patients (n=48). In addition, estimated invasive ventilator-free survival was 96 percent for treated patients (n=54) compared to 31 percent for historical control patients (n=48). Study results also demonstrated substantial improvements in the skeletal manifestations of HPP, as assessed by the Radiographic Global Impression of Change (RGI-C) scale, and improvements in height and weight, as measured by z-scores, in patients treated with Strensiq. In patients (ages 6 to 12 years) with juvenile-onset HPP, treatment with Strensiq resulted in significant improvements in the skeletal manifestations of HPP at 24 weeks, as measured by RGI-C, compared to historical controls. Importantly, by month 54, 100 percent of Strensiq-treated juvenile-onset patients were responders to treatment (n=8), as measured by substantial bone healing, compared to 6 percent of patients in the historial control group (n=32) at last assessment. In addition, patients treated with Strensiq had improvements in height and weight, as measured by z-scores, compared with untreated historical controls, as well as improvements in gait and mobility. By 4 years of treatment, 100 percent of patients assessed (n=6) achieved the 6 Minute Walk Test within the normal range for age-, sex- and height-matched peers, whereas no patients were in the normal range at baseline. The most commonly reported adverse events observed in clinical trials were injection site reactions. Other common adverse reactions included lipodystrophy, ectopic calcifications, and hypersensitivity reactions. Conference Call Alexion will host a conference call/webcast on Monday, October 26, 2015, at 8:30 a.m. ET to discuss the FDA approval. To participate in this call, dial (866) 433-3833 (USA) or (704) 908-0448 (international), confirmation code 60248704, shortly before 8:30 a.m. ET. A replay of the call will be available for a limited period following the call, beginning at 7:30 p.m. ET. The replay number is (855) 859-2056 (USA) or (404) 537-3406 (international), confirmation code 60248704. The audio webcast can be found on the Investor page of Alexion’s website at: ir.alexionpharm.com. About Hypophosphatasia (HPP) HPP is a genetic, chronic, progressive, and life-threatening ultra-rare metabolic disease characterized by low alkaline phosphatase (ALP) activity and defective bone mineralization that can lead to destruction and deformity of bones and other skeletal abnormalities, as well as systemic complications such as profound muscle weakness, seizures, pain, and respiratory failure leading to premature death in infants.1-5 HPP is caused by mutations in the gene encoding an enzyme known as tissue non-specific alkaline phosphatase (TNSALP).1,2 The genetic deficiency in HPP can affect people of all ages.1 HPP is traditionally classified by the age of the patient at the onset of symptoms of the disease, with perinatal-, infantile- and juvenile-onset HPP defined as patients who have their first symptom prior to 18 years of age. HPP can have devastating consequences for patients at any stage of life.1 In a natural history study, infants who had their first symptom of HPP within the first 6 months of life had high mortality, with an overall mortality rate of 73 percent at 5 years.8 In these patients, mortality is primarily due to respiratory failure.1,5,9 In patients surviving and those with juvenile-onset HPP, long-term clinical sequelae include recurrent and non-healing fractures, profound muscle weakness, debilitating pain, and the requirement for ambulatory assistive devices such as wheelchairs, wheeled walkers, and canes.1,4 About Strensiq™ (asfotase alfa) Strensiq™ (asfotase alfa) is a highly innovative bone-targeted enzyme replacement therapy that treats the underlying cause of HPP by replacing the missing TNSALP enzyme. In clinical studies of patients with HPP who had their first symptom prior to the age of 18, treatment with Strensiq improved overall survival in infants, enhanced bone mineralization, and improved height, weight, and mobility. Strensiq is approved in the United States, European Union, Japan, and Canada. Important Safety Information Hypersensitivity reactions have been reported in STRENSIQ-treated patients. In clinical trials, 1 out of 99 treated patients (1%) experienced signs and symptoms consistent with anaphylaxis. Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ. Patients with HPP are at increased risk for developing ectopic calcifications. In clinical trials, 14 cases (14%) of ectopic calcification of the eye including the cornea and conjunctiva, and the kidneys (nephrocalcinosis) were reported. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to STRENSIQ. No visual changes or changes in renal function were reported. The most common adverse reactions reported were injection site reactions, lipodystrophy, ectopic calcifications, and hypersensitivity reactions. Please click here for the full Prescribing Information. About Alexion Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq™ (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. This press release and further information about Alexion can be found at: .alexion.com. [ALXN-G] Forward-Looking Statements This news release contains forward-looking statements, including statements related to potential medical benefits of Strensiq™(asfotase alfa) for hypophosphatasia (HPP). Forward-looking statements are subject to factors that may cause Alexion s results and plans to differ from those expected, including for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of Strensiq for HPP, delays in arranging satisfactory manufacturing capabilities and establishing commercial infrastructure for Strensiq for HPP, the possibility that results of clinical trials are not predictive of safety and efficacy results of Strensiq in broader or different patient populations, the risk that third party payors (including governmental agencies) will not reimburse for the use of Strensiq at acceptable rates or at all, the risk that estimates regarding the number of patients with Strensiq and observations regarding the natural history of patients with Strensiq are inaccurate, and a variety of other risks set forth from time to time in Alexion s filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion s Quarterly Report on Form 10-Q for the period ended June 30, 2015. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law. References 1. Rockman-Greenberg C. Hypophosphatasia. Pediatr Endocrinol Rev. 2013; 10(suppl 2):380-388. 2. Whyte MP. Hypophosphatasia: nature’s window on alkaline phosphatase function in humans. In: Bilezikian JP, Raisz LG, Martin TJ, eds. Principles of Bone Biology. Vol 1. 3rd ed. San Diego, CA: Academic Press; 2008:1573-1598. 3. Whyte MP, Greenberg CR, Salman N, et al. Enzyme-replacement therapy in life-threatening hypophosphatasia. N Engl J Med. 2012; 366(10):904-913. 4. Seshia SS, Derbyshire G, Haworth JC, Hoogstraten J. Myopathy with hypophosphatasia. Arch Dis Child. 1990; 65(1):130-131. 5. Baumgartner-Sigl S, Haberlandt E, Mumm S, et al. Pyridoxine-responsive seizures as the first symptom of infantile hypophosphatasia caused by two novel missense mutations (c.677T>C, p.M226T; c.1112C>T, p.T371I) of the tissue-nonspecific alkaline phosphatase gene. Bone. 2007; 40(6):1655-1661. 6. REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. eur-lex.europa.eu/legal content/EN/TXT/PDF/?uri=CELEX:32014R0536&qid=1421232837997&from=EN. 7. Strensiq™ U.S. Prescribing Information, 2015. 8. Whyte MP, Leung E, Wilcox W, et al. Hypophosphatasia: a retrospective natural history study of the severe perinatal and infantile forms. Poster presented at the 2014 Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting, Vancouver, B.C., Canada, May 5, 2014. Abstract 752416. 9. Whyte MP, Rockman-Greenberg C, Hofmann C, et al. Improved survival with asfotase alfa treatment in pediatric patients with hypophosphatasia at high risk of death. Poster presented at the American Society for Bone and Mineral Research (ASBMR) 2014 Annual Meeting, Houston, September 14, 2014. Abstract 1097.

Feld Entertainment y Primary Children’s Hospital Anuncian Nuevo Esfuerzo de Financiaci'on de Investigaci'on del C'ancer

ELLENTON, Florida.--(BUSINESS WIRE)--La familia de Feld, propietarios de Feld Entertainment, Inc., la compa~n ia matriz de Ringling Bros. Buy Cialis (Tadalafil) without Rx and Barnum & Bailey® y el Ringling Bros. Tadora (Tadalafil) with no Rx Center for Elephant Conservation®, anunci o hoy un nuevo esfuerzo de financiaci on con el Dr. Levothroid (Levothyroxine) with free Rx Joshua Schiffman, Onc ologo Pedi atrico del Intermountain Primary Children’s Hospital (PCH), del Departamento de Pediatr ia de la Universidad de Utah e Investigador del Huntsman Cancer Institute. Geodon with no Rx El compromiso de recaudaci on de fondos viene de la mano de los nuevos resultados de la investigaci on de c ancer pedi atrico publicados en el Journal of American Medical Association (JAMA) por el Dr. Etodolac (Etodolac) without Rx Schiffman. El Dr. Buy Essential Oils online Schiffman y el equipo del Primary Children’s Hospital, el Departamento de Pediatr ia y el Huntsman Cancer Institute, todos en Salt Lake City, Utah, est an estudiando por qu e existe una baja incidencia de c ancer en los elefantes, qu e hace posible esta resistencia al c ancer en los elefantes y no en los seres humanos y c omo puede correlacionarse esto con los nuevos tratamientos para los c anceres pedi atricos. M as de 16 000 ni~nos y adolescentes son diagnosticados con c ancer cada a~no en los Estados Unidos; mientras tanto, los elefantes casi no experimentan c ancer durante su vida. http://webmd-magazine.blogspot.com El Dr. Schiffman, Presidente de Servicios Veterinarios; el Dr. Dennis Schmitt, Director de Investigaci on de Ringling Bros. and Barnum & Bailey; y la Dra. Wendy Kiso, Cient ifica de Conservaci on e Investigadora del Ringling Bros. and Barnum & Bailey; y otros colaboradores cient ificos en su equipo; recientemente confirmaron que los elefantes rara vez desarrollan c ancer con una tasa de mortalidad de menos del 5 % en comparaci on con un 25 % en los seres humanos. Al mirar el genoma del elefante, describieron que los elefantes tienen 40 copias de un gen supresor de tumores denominado TP53 en comparaci on con s olo dos copias en los seres humanos. Trabajando con el Zoo Hogle de Utah y el Ringling Bros. Center for Elephant Conservation, el Dr. Schiffman y sus colegas estudiaron la respuesta de la sangre de elefante a los agentes que da~nan el ADN y descubrieron que las c elulas de elefantes sufren muerte celular m as r apidamente en comparaci on con las c elulas humanas . El Dr. Schiffman cree que esta puede ser la raz on por la cual los elefantes desarrollan menos c ancer que los humanos. Los resultados completos del estudio se han publicado en la nueva edici on del Journal of American Medical Association. "Con esta asociaci on entre Ringling Bros. y Primary Children’s Hospital, ahora estamos estudiando c omo aplicar estos descubrimientos a los ni~nos y las familias en mayor riesgo de desarrollar c ancer", se~nal o el Dr. Schiffman. "Queremos usar estas lecciones de la naturaleza para prevenir, desarrollar herramientas de identificaci on precoz y tratar el c ancer en los seres humanos". La aplicaci on de la investigaci on traslacional en torno al c ancer, los hallazgos de la ciencia b asica que mejoran la salud humana, el bienestar mediante la mejora de las pr acticas m edicas y de enfermer ia y la creaci on de los resultados de salud significativos, podr ia allanar el camino para una nueva frontera de la investigaci on y tratamiento del c ancer, desde la mesa de laboratorio hasta la cabecera del paciente. "Hace veinte a~nos, fundamos la Ringling Bros. Center for Elephant Conservation para preservar al elefante asi atico en peligro de extinci on para las generaciones futuras. Poco sab iamos entonces que ellos pueden ser la clave para el tratamiento del c ancer y estamos tremendamente emocionados de ser parte de esto", se~nal o Kenneth Feld, Presidente y Director Ejecutivo de Feld Entertainment. La familia Feld est a constituyendo Ringling Bros. Children’s Fund™ como un elemento de su filantrop ia en curso a trav es de la Feld Family Foundation para apoyar a las organizaciones ben eficas para ni~nos. Como parte de la asociaci on con Primary Children’s Hospital, el Departamento de Pediatr ia, y el Dr. Schiffman, the Ringling Bros. Children’s Fund y Ringling Bros. and Barnum & Bailey donar an m as de 1 mill on de USD para apoyar la investigaci on del c ancer y para cuidar a los ni~nos. En las pr oximas 50 visitas a ciudades, Ringling Bros. y Barnum & Bailey , Ringling Bros. donar an 10 000 USD a un hospital o centro de tratamiento para ni~nos local y la Ringling Bros. Children’s Fund igualar a cada donaci on con otra de 10 000 USD a la Primary Children’s Hospital Foundation para apoyar el PCH Pediatric Cancer Research Program. Este programa, que ayud o a apoyar la investigaci on en el elefante, se concentra en los nuevos enfoques para la prevenci on, el diagn ostico y la mejora del valor de la atenci on oncol ogica pedi atrica. "En Ringling Bros., entretenemos a las familias y retribuimos a las comunidades en las que nos desempe~namos cada semana. Adem as de las contribuciones financieras realizadas por Feld Entertainment y el Ringling Bros. Children’s Fund, llevaremos a nuestros artistas directamente a los hospitales para entretener a las familias que no pueden ir al espect aculo", se~nal o Alana Feld, Vicepresidenta Ejecutiva de Feld Entertainment y Productora de Ringling Bros. and Barnum & Bailey. "Esta asociaci on en curso para recaudar fondos para la investigaci on con Ringling Bros. nos permite ayudar con nuevos protocolos de tratamiento del c ancer, que proporcionan un enfoque m as innovador e integrado para el tratamiento del c ancer y ofrecer mejores resultados a largo plazo y apoyar a las familias a trav es de la atenci on a largo plazo", se~nala el Dr. Richard Lemons, Director M edico y Jefe de Hematolog ia/Oncolog ia Pedi atrica en el Primary Children s Hospital. El Dr. Lemons supervisa el PCH Pediatric Cancer Research Program. "El c ancer afecta a tantas familias en este condado y por desgracia se est a volviendo m as com un, especialmente entre los ni~nos. Tenemos la esperanza de que nuestra investigaci on dar a lugar a nuevas perspectivas de mejores tratamientos para el c ancer pedi atrico", manifiesta Katy Welkie, Directora Ejecutiva de Primary Children’s Hospital. Se puede encontrar informaci on adicional acerca de Ringling Bros. and Barnum & Bailey y el Ringling Bros. Center for Elephant Conservation, la asociaci on y la informaci on sobre c omo las familias pueden donar a la investigaci on en l inea, en .ringling.com y .ringlingelephantcenter.com. Acerca de Feld Entertainment Feld Entertainment es el l ider mundial en la producci on y presentaci on de experiencias de entretenimiento familiar en vivo que elevan el esp iritu humano y crean recuerdos imborrables, con 30 millones de asistentes a sus espect aculos cada a~no. Las producciones de Feld Entertainment han aparecido en m as de 75 pa ises y en seis continentes hasta la fecha e incluyen a Ringling Bros. and Barnum & Bailey®, Monster Jam®, Monster Energy Supercross, AMSOIL Arenacross, Disney On Ice Presented by Stonyfield YoKids Organic Yogurt, Disney Live! Presentado por Stonyfield YoKids Organic Yogurt y Marvel Universe LIVE! M as informaci on acerca de Feld Entertainment est a disponible en l inea en .feldentertainment.com. M as informaci on acerca de Ringling Bros. Center for Elephant Conservation est a disponible en .ringlingelephantcenter.com. Acerca de Primary Children’s Hospital Primary Children s Hospital es el unico hospital de servicio completo para ni~nos de Utah, Idaho, Wyoming, Nevada y Montana que ofrece atenci on a los ni~nos con las lesiones y enfermedades m as complejas, incluidas aquellas que requieren trasplantes de coraz on, h igado, ri~n on y m edula osea. Primary Children’s es el unico Centro de Trauma Pedi atrico de Nivel 1 en el Intermountain West. Es propiedad de Intermountain Healthcare, un sistema de salud sin fines de lucro, y est a afiliado a la Facultad de Medicina de la Universidad de Utah, que re une la investigaci on, la capacitaci on y la excelente atenci on para proporcionar la mejor atenci on m edica para los ni~nos. Las donaciones son administradas por Primary Children’s Hospital Foundation, una organizaci on ben efica p ublica constituida por separado bajo el c odigo del IRS 501(c)(3). La fundaci on apoya los objetivos del hospital de proporcionar el m as alto nivel de atenci on pedi atrica en un ambiente de amor y preocupaci on. Acerca del Departamento de Pediatr ia de la Universidad de Utah El Departamento de Pediatr ia es el segundo departamento m as grande de la Facultad de Medicina de la Universidad de Utah y es uno de los mayores departamentos de pediatr ia en el pa is. Existen 270 miembros de la facultad en el departamento con una distribuci on bastante equitativa de hombres y mujeres, y tenemos el mayor n umero de profesores titulares femeninos en la Facultad de Medicina. El departamento est a compuesto por 22 divisiones y programas m edicos que funcionan en conjunto con cuatro empresas clave: Educaci on, Investigaci on, Cl inica y Acad emica. Las divisiones ofrecen un espectro completo de servicios de pediatr ia de especialidades y subespecialidades para ni~nos en todo el Intermountain West. Acerca de Huntsman Cancer Institute de la Universidad de Utah El Huntsman Cancer Institute (HCI) es uno de los principales centros de investigaci on y tratamiento del c ancer acad emicos del mundo. HCI gestiona la Utah Population Database , la base de datos gen etica m as grande del mundo, con m as de 16 millones de registros vinculados a las genealog ias, los registros de salud y las estad isticas vitales. Con estos datos, los investigadores de HCI han identificado varios genes que causan c ancer, incluidos los genes responsables del melanoma, el c ancer de colon y de mama, y el paraganglioma. HCI es miembro de la National Comprehensive Cancer Network (una alianza de 26 miembros de los centros de c ancer m as importantes del mundo) y es un National Cancer Institute-Designated Comprehensive Cancer Center. HCI trata a los pacientes con todas las formas de c ancer y opera diversas cl inicas de alto riesgo que se enfocan en el melanoma y en los c anceres de mama, colon y de p ancreas. El HCI Cancer Learning Center para el paciente y la educaci on p ublica contiene una de las colecciones m as grandes del pa is de publicaciones relacionadas con el c ancer. El instituto lleva el nombre de Jon M. Huntsman, un fil antropo de Utah, industrial y sobreviviente de c ancer. El texto original en el idioma fuente de este comunicado es la versi on oficial autorizada. Las traducciones solo se suministran como adaptaci on y deben cotejarse con el texto en el idioma fuente, que es la unica versi on del texto que tendr a un efecto legal.

FIBC Market – Global Forecast & Analysis Now Available from Technavio

. Buy Fosinopril with free prescription LONDON--(BUSINESS WIRE)--Technavio has published a new report on the global flexible intermediate bulk container (FIBC) market, which is expected to grow at a CAGR of more than 7% from 2015-2019. FIBC market segmentation including end-user and geography Technavio’s report analyses the solutions and products offered by market vendors and presents a comprehensive breakdown in terms of market segmentation for different end-users, including chemical, food, pharmaceutical, and other. Additionally, analysts have segmented market projections by key geography, focusing on the Americas, Europe, the APAC, and the EMEA region. “The growing environmental concern about the usage of synthetic plastic, which is mostly derived from petroleum feedstock, has encouraged the market to develop eco-friendly plastics for consumers. Buy Glucovance (Metformin/Glyburide) About Avelox (Moxifloxacin) without Rx Generally, polypropylene and polyethylene are the two widely-used plastics for the production of FIBC. Buy Devil's Claw online About Viagra Professional (Sildenafil Citrate) without prescription However, an increase in the demand for bio-based products has shifted the focus of manufacturers from synthetic to bio-based polypropylene for the production of FIBCs,” says Faisal Ghaus, Vice President of Technavio. FIBC: Market scope and calculation of market size This report covers the present scenario and growth prospects for the global FIBC market from 2015-2019. http://webmd-help.blogspot.com Elocon (Mometasone) with no prescription To calculate the market size, the report considers the volume of FIBCs used by the various industry segments such as food, pharmaceutical, chemical, and other (includes construction, fertilizers, and mining and minerals industries). Industry analysis includes: Key Vendors: Berry Plastics Conitex Sonoco Global-Pak Greif Flexible Products & Services Plastipak Group Market Growth Drivers: Increase in demand from end-users Production of innovative FIBCs Market Challenges: Volatility in raw material prices Low UV resistance of FIBCs Market Trends: Use of bio-based raw materials High demand from Europe and North America View the global flexible intermediate bulk container (FIBC) market report. Technavio currently has more than 3000 market research reports on a huge range of topics, including 200+ reports on the container market: Global Food Container Market 2015-2019 Global Beverage Containers Market 2015-2019 If you are interested in more information, please contact our media team at media@technavio.com.

Europees CHMP aanvaardt positief advies voor Gilead’s enkeltabletregime Genvoya® (Elvitegravir, Cobicistat, Emtricitabine en Tenofovir Alafenamide) voor de behandeling van hiv

FOSTER CITY, Californi"e--(BUSINESS WIRE)--Gilead Sciences, Inc. Adalat (Nifedipine) (Nasdaq:GILD) heeft vandaag bekendgemaakt dat het Comit e voor geneesmiddelen voor menselijk gebruik (Committee for Medicinal Products for Human Use, CHMP), de wetenschappelijke commissie van het Europees Geneesmiddelenbureau (EGb - European Medicines Agency, EMA) een positief advies heeft gegeven voor de aanvraag van de vergunning voor het in de handel brengen (Marketing Authorization Application, MAA) van het bedrijf voor het onderzoeksregime van eenmaal daags een enkel tablet Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg) voor de behandeling van HIV-1-infectie. Buy Zithromax (Azithromycin) without prescription De in de MAA ingediende gegevens ondersteunen het gebruik van het regime bij behandelingsna"ieve volwassenen en adolescenten, virologisch onderdrukte volwassenen die van regime wisselen en volwassenen met lichte tot matige nierfunctiestoornis. De aanbeveling van het CHMP zal nu worden getoetst door de Europese Commissie, die de bevoegdheid heeft om voor de 28 landen van de Europese Unie geneesmiddelen goed te keuren voor gebruik. Cialis Light Pack-30 () without prescription Als het wordt goedgekeurd zal Genvoya Gilead’s eerste enkeltabletregime zijn dat TAF bevat. TAF is een nieuwe experimentele nucleotide reverse-transcriptaseremmer (NRTI) die in klinisch onderzoek in combinatie met andere antiretrovirale middelen hoge antivirale werkzaamheid liet zien bij een dosis die minder dan een tiende is van de dosis van Viread® (tenofovirdisoproxilfumaraat, TDF) van Gilead, evenals verbetering van de surrogaatlaboratoriummarkers van nier- en botveiligheid in vergelijking met TDF. De MAA voor Genvoya wordt ondersteund door gegevens na 48 weken onderzoek van twee cruciale fase 3-onderzoeken (Studies 104 en 111) waarin het regime voldeed aan het primaire doel van niet-inferioriteit vergeleken met Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovirdisoproxilfumaraat 300 mg) onder behandelingsna"ieve volwassen pati"enten. Buy Fluorouracil without prescription Genvoya liet in de studies verbetering zien in surrogaatlaboratoriummarkers van nier- en botveiligheid vergeleken met Stribild. About Jelly Pack-30 () De MAA wordt ook ondersteund door gegevens uit aanvullende fase 3-studies die het op TAF gebaseerde regime beoordelen onder adolescenten, volwassen pati"enten met virologische onderdrukking die overgingen op Genvoya en volwassen pati"enten met lichte tot matige nierfunctiestoornis. Naast Genvoya zijn er momenteel twee andere op TAF gebaseerde regimes onder beoordeling van de EMA. Buy Colloidal Minerals online Het eerste regime is een onderzoeks-, vastedosiscombinatie van emtricitabine 200 mg en tenofovir alafenamide 25 of 10 mg (F/TAF) voor gebruik in combinatie met andere antiretrovirale middelen. http://webmd-review.blogspot.com Het tweede is een onderzoeksregime van eenmaal daags een enkel tablet, dat emtricitabine 200 mg, tenofovir alafenamide 25 mg en rilpivirine 25 mg (R/F/TAF) combineert. Emtricitabine en tenofovir alafenamide zijn van Gilead Sciences en rilpivirine is van Janssen Sciences Ireland UC, e en van de Janssen Pharmaceutical Companies van Johnson & Johnson. TAF en alle op TAF gebaseerde regimes zijn onderzoeksproducten en hun veiligheid en werkzaamheid zijn in de Europese Unie niet vastgesteld. Over Gilead Gilead Sciences is een biofarmaceutisch bedrijf dat innovatieve behandelingen ontdekt, ontwikkelt en op de markt brengt voor medische behoeften waar nog geen oplossingen voor zijn. De missie van het bedrijf is om wereldwijd de zorg te verbeteren voor pati"enten die aan levensbedreigende ziekten lijden. Gilead heeft bedrijven in meer dan 30 landen wereldwijd en het hoofdkantoor is gevestigd in Foster City, Californi"e. Toekomstgerichte verklaring Dit persbericht bevat toekomstgerichte verklaringen (forward-looking statements) binnen de betekenis van de Private Securities Litigation Reform Act van 1995, die onderworpen zijn aan risico s, onzekerheden en andere factoren, waaronder het risico dat de MAA voor Genvoya, F/TAF en/of R/F/TAF niet zal worden goedgekeurd door de EMA en dat goedkeuring voor het in de handel brengen, indien verleend, belangrijke beperkingen kan hebben voor het gebruik ervan. Deze risico’s, onzekerheden en andere factoren kunnen ertoe leiden dat de werkelijke resultaten aanzienlijk afwijken van de resultaten zoals die worden genoemd in de toekomstgerichte verklaringen. De lezer wordt gewaarschuwd zich niet te baseren op deze toekomstgerichte verklaringen. Deze en andere risico s staan in detail beschreven in het kwartaalverslag van Gilead op formulier 10-Q voor het kwartaal dat eindigde op 30 juni 2015, zoals ingediend bij de Amerikaanse Securities and Exchange Commission. Alle toekomstgerichte verklaringen zijn gebaseerd op informatie waarover Gilead momenteel beschikt en Gilead neemt geen verplichting op zich om dergelijke toekomstgerichte verklaringen te actualiseren. De Europese SmPC s voor Stribild en Viread zijn beschikbaar op de website van het EMA: .ema.europa.eu. Genvoya, Stribild en Viread zijn geregistreerde handelsmerken van Gilead Sciences, Inc. of de aan haar gelieerde bedrijven. Ga voor meer informatie over Gilead Sciences naar de website van het bedrijf: .gilead.com, volg Gilead op Twitter (@GileadSciences) of bel Gilead Public Affairs: 1-800-GILEAD-5 of 1-650-574-3000. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

Fresenius Kabi Introduces Moxifloxacin Injection 400mg per 250mL in Freeflex® Bags

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi USA announced today it has introduced the anti-infective Moxifloxacin Injection 400 mg per 250 mL in Freeflex® bags. Buy Zestoretic (Lisinopril-Hctz) This is a first-to-market alternative for this injectable drug which had previously been available only from the innovator. Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition. Moxifloxacin is the third premix product Fresenius Kabi has introduced in the United States since 2013 using the company’s proprietary Freeflex delivery system. Bimatoprost (Bimatoprost) with no prescription Freeflex is a non-PVC and non-DEHP flexible bag for infusion solutions using patented port technology and clear labeling. "Fresenius Kabi is pleased to offer this first and only alternative to Avelox Injection for our customers and the patients they serve,” said John Ducker, president and CEO of Fresenius Kabi USA. Toprol (Metoprolol) “The introduction of Moxifloxacin expands both our leading anti-infective portfolio and our ready-to-use intravenous offerings in the U.S." Moxifloxacin Injection Important Safety Information (ISI) BOXED WARNING: WARNING: TENDON EFFECTS and MYASTHENIA GRAVIS See full prescribing information for complete boxed warning Fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. Fasigyn with no Rx This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Buy Mestinon (Pyridostigmine) without Rx Discontinue if pain or inflammation in a tendon occurs. Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Buy Carb Blockers online Avoid moxifloxacin in patients with known history of myasthenia gravis. Indications and Usage Moxifloxacin injection is indicated for the treatment of adults (18 years of age or older) with infections caused by susceptible isolates of the designated microorganisms in the conditions listed below. · Acute Bacterial Sinusitis · Acute Bacterial Exacerbation of Chronic Bronchitis · Community Acquired Pneumonia · Uncomplicated Skin and Skin Structure Infections · Complicated Skin and Skin Structure Infections · Complicated Intra-Abdominal Infections To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA Vigilance & Medical Affairs at 1-800-551-7176 or FDA at 1-800-FDA-1088 or .fda.gov/medwatch. Please see full Prescribing Information, including BOXED WARNING, available at .fresenius-kabi.us. About Fresenius Kabi Fresenius Kabi (.fresenius-kabi.us) is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. http://webmd-consult.blogspot.com The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. Avelox® is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation, a subsidiary of Merck & Co., Inc.

Global Motilin Receptor Agonists Pipeline Insights Review 2015

. Professional Pack-40 () without prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/lcrs5p/motilin_receptor) has announced the addition of the "Motilin Receptor Agonists -Pipeline Insights" report to their offering. Motilin Receptor Agonists Pipeline Insights provides the in-depth analysis of the pipeline assets across the Motilin Receptor Agonists. Buy Barley Grass online Spiriva (Tiotropium Bromide) without prescription The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. http://web-md.blogspot.com Buy Differin (Adapalen) with no Rx The Motilin Receptor Agonists Report helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. Motilin Receptor Agonists Pipeline Insights Report covers the Motilin Receptor Agonists pipeline molecules at various stages of development like Pre-registration phase, clinical phases (Phase III, Phase II & Phase I), pre-clinical and discovery phases. About Trecator-SC (Ethionamide) with free Rx The Report also provides Motilin Receptor Agonists related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. Encorate with free Rx The Report also highlights the discontinued and inactive projects in pipeline for Motilin Receptor Agonists. Key Topics Covered: Motilin Receptor Agonists Overview Motilin Receptor Agonists Disease Associated Motilin Receptor Agonists Pipeline Therapeutics Motilin Receptor Agonists Therapeutics under Development by Companies Motilin Receptor Agonists Late Stage Products (Filed and Phase III) Comparative Analysis Motilin Receptor Agonists Mid Clinical Stage Products (Phase II) Comparative Analysis Motilin Receptor Agonists Early Clinical Stage Products (Phase I and IND Filed) Comparative Analysis Motilin Receptor Agonists Discovery and Pre-Clinical Stage Products Comparative Analysis Drug Candidate Profiles Motilin Receptor Agonists - Therapeutics Assessment Assessment by Monotherapy Products Assessment by Combination Products Assessment by Route of Administration Assessment by Molecule Type Motilin Receptor Agonists - Discontinued Products Motilin Receptor Agonists - Dormant Products Companies Involved in Therapeutics Development for Motilin Receptor Agonists Appendix For more information visit .researchandmarkets.com/research/lcrs5p/motilin_receptor

Astex Pharmaceuticals Announces Publication of Key Clinical Data for Guadecitabine (SGI-110) in The Lancet Oncology

PLEASANTON, Calif.--(BUSINESS WIRE)--Astex Pharmaceuticals, a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announces the publication of key clinical data for the novel hypomethylating agent (HMA) guadecitabine (SGI-110) in the prestigious journal, The Lancet Oncology. Buy Rhinocort (Budesonide) The publication, entitled “Pharmacokinetic and Pharmacodynamic-guided Phase 1 study of the novel hypomethylating drug guadecitabine (SGI-110) in myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML)”, was released online on August 18, 2015 at .thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00038-8/abstract. The publication describes the first-in-human clinical trial of 93 heavily pre-treated patients (74 AML and 19 MDS) treated with guadecitabine and reports that the drug is well-tolerated, easily administered, and biologically and clinically active in both MDS and AML patients who relapsed after standard of care. Eldepryl (Selegiline) with free prescription Importantly, potent dose-related DNA demethylation is associated with clinical responses in patients treated with guadecitabine, with responders showing significantly more demethylation than non-responders. Buy Amoxil (Amoxicillin) without prescription The study was conducted at 13 leading cancer centers in the US and Canada. The results described in this publication were used to inform the design of a large Phase 2 study in both treatment na"ive and relapsed / refractory AML and MDS, in which over 300 patients were treated with guadecitabine, and a recently-commenced 800-patient global Phase 3 study (ASTRAL-1), in which guadecitabine is being compared with physician’s choice of decitabine, azacitidine, or low-dose cytarabine in treatment na"ive AML patients unfit to receive, or unsuitable for, intensive induction chemotherapy. Lead Author, Jean-Pierre Issa, MD of Fels Institute for Cancer Research and Molecular Biology, Temple University School of Medicine said, “This study demonstrates that guadecitabine is safe, and showed that the drug resulted in improved PK exposure and PD demethylation over what has been reported for the first-generation HMAs. Buy Elestat with no prescription It also confirmed the importance of DNA demethylation as a PD marker for clinical response." Dr. About Requip (Ropinirole) without Rx Issa added, “Guadecitabine’s improved PK and PD profile may improve clinical outcomes in patients with hematologic malignancies, and may also make the drug useful in the treatment of solid tumors, an area in which first generation HMAs are not currently approved.” Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, the senior author of the study said: “In this study we observed induced clinical responses in heavily pre-treated patients including prior treatment with current HMAs. Buy Apple Cider Vinegar online Together with the results of a large Phase 2 study to be published later, these data support further investigation, including the recently commenced global Phase 3 study in treatment-na"ive AML patients.” About guadecitabine (SGI-110): Guadecitabine is a novel next-generation small molecule, DNA hypomethylating agent designed to be administered as a single, small volume, subcutaneous injection. http://cholesterolreviews.wordpress.com Guadecitabine demonstrated activity in restoring silenced tumor suppressor gene expression in cancer cells by reversal of DNA methylation and inducing responses in previously treated MDS and AML patients. Guadecitabine is wholly owned by Astex Pharmaceuticals. About the SGI-110 study in MDS and AML patients (Study SGI-110-01): The SGI-110-01 trial is a large (over 400 patients) randomized Phase 1/2 study in patients with MDS or AML. The trial included a Phase I dose escalation stage (93 patients) and a randomized Phase 2 stage (308 patients) that investigated four patient populations: treatment na"ive and relapsed / refractory AML and MDS, and also explored both a dailyx5 and a dailyx10 regimen. Additional information about the study can be found online at clinicaltrials.gov/ct2/show/NCT01261312. About the ASTRAL-1 SGI-110 study (Study SGI-110-04) ASTRAL-1 is a large, global, randomized 800-patient study of guadecitabine (SGI-110) in treatment na"ive AML patients who are unfit to receive, or unsuitable for, intensive induction chemotherapy. The trial commenced in March 2015, and compares guadecitabine with physician’s choice of low-dose cytarabine, decitabine or azacitidine. Additional information about the study can be found online at .clinicaltrials.gov/ct2/show/NCT02348489. About Astex Pharmaceuticals Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. In October 2013, Astex was acquired by Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan, and operates as a wholly owned subsidiary. The Otsuka Group employs approximately 43,000 people globally, and its products are available in more than 80 countries worldwide. For more information about Astex Pharmaceuticals, please visit .astx.com For more information about Otsuka Pharmaceutical, please visit .otsuka.com/en/

Partnerships, Licensing, Investments and M&A Deals and Trends for May 2015 in Pharmaceuticals - Analysis of Partnership and Licensing Deals Based on Clinical Stage of Development of Products

. About Doxacard with free Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/c46hn3/partnerships) has announced the addition of the "Partnerships, Licensing, Investments and M&A Deals and Trends for May 2015 in Pharmaceuticals" report to their offering. Partnerships, Licensing, Investments and M&A Deals and Trends for May 2015 in Pharmaceuticals Summary Our Partnerships, Licensing, Investments and M&A Deals and Trends for May 2015 in Pharmaceuticals report is an essential source of data and trend analysis on partnerships, licensing, mergers and acquisitions (M&As) and financings in the pharmaceuticals industry. About Super P-Force (Sildenafil with Dapoxetine) with no prescription Buy Norvasc (Amlodipine) without prescription The report provides detailed information on partnership and licensing transactions, M&As, equity/debt offerings, private equity, and venture financing registered in the pharmaceuticals industry in May 2015. Buy Weight Loss Patches online Buy Isordil (Isosorbide Dinitrate) without prescription The report portrays detailed comparative data on the number of deals and their value in the last six months, subdivided by deal types, various therapy areas, and geographies. http://allergy-opinion.blogspot.com About Serophene (Clomiphene) with no Rx Additionally, the report provides information on the top financial advisory firms in the pharmaceuticals industry. Scope Review of deal trends in the cardiovascular, central nervous system, dermatology, ear nose throat disorders, gastrointestinal, genito urinary system and sex hormones, hematological disorders, hormonal disorders, immunology, infectious disease, male health, metabolic disorders, mouth and dental disorders, musculoskeletal, oncology, ophthalmology, respiratory, toxicology, and women s health segments. Analysis of partnerships, licensing, M&As, equity/debt offerings, private equity, and venture financing deals in the pharmaceutical industry. Analysis of therapy areas which are very active in terms of venture capital financing, partnerships, licensing agreements, equity/debt offerings, and M&As. Key Topics Covered: 1 List of Tables and List of Figures 2 Pharmaceuticals & Healthcare, Global, Deal Summary 3 Pharmaceuticals and Healthcare, Global, Deals, Summary, by Type 4 Pharmaceuticals & Healthcare, Global, Partnership Deals, May 2015 5 Pharmaceuticals & Healthcare, Global, Licensing Agreements, May 2015 6 Pharmaceuticals & Healthcare, Global, Deal Summary by Therapy Area 7 Deal Summary by Geography 8 Pharmaceuticals & Healthcare, Global, Top Financial Advisors 9 Further Information For more information visit .researchandmarkets.com/research/c46hn3/partnerships

Survey Shows Need for Greater Consistency in “Real World” Observational Research

. http://asthmareview.wordpress.com NORTHBROOK, Ill.--(BUSINESS WIRE)--According to a recent survey, the pharmaceutical, biotech, and medical device industries are aware of the benefits of observational research in better understanding the real world value of their products; however, there is continued need to improve the design and implementation of the studies. Results from the 9th Annual Survey on Observational Research conducted by Continuum Clinical were released in a white paper today. While more traditional controlled clinical trials are the conventional pathway for regulatory approval of drugs, observational studies are increasingly viewed as essential for companies interested in understanding how their products perform under actual medical conditions. “Controlled clinical research remains the gold-standard for regulatory approval,” said Jeff Trotter, President of Continuum Clinical, and author of the survey. About Motilium (Domperidone) with no prescription “But other stakeholders including payers, physicians, and patients need to understand a product’s clinical, economic and humanistic value once it is approved and being prescribed and utilized in the ‘real world.’ As a result, drug and device companies must generate these data through studies that are designed and implemented under post-approval conditions.” The survey reveals ten key findings about prospective observational studies, and identifies opportunities for drug and device companies to improve the implementation of real world research. Lanoxin (Digoxin) without prescription Among the key findings were: 70% of respondents see their organizations becoming increasingly involved with observational studies, and 75% see their company “comfort level” improving Less than half of respondents indicated that their organizations had Standard Operating Procedures (SOPs) specific to observational studies 83% of respondents felt constrained in utilizing vendors [for observational research] that don’t understand observational research A vastly underutilized source for enrolling patients into observational studies was “patients interested in but not qualifying for pre-approval clinical trials” Trotter added, “What we’re seeing is that there’s strong consensus that observational research is critical, but a lot of confusion regarding how to efficiently and effectively implement the studies.” Over its nine iterations, the survey has enjoyed the participation of approximately 2,000 respondents worldwide who represent a cross-section of the pharmaceutical industry and job functions. For complete survey results and to download the 9th Survey on Observational Research, visit .continuumclinical.com/research. About Continuum Clinical Continuum Clinical is a global healthcare research and communications company. Buy Danazol () with free Rx With over thirty years of experience, Continuum Clinical brings together a unique blend of world-class experience in key disciplines, including post-approval research, marketing, communications, health economics, and outcomes research. Divaa without prescription We excel in providing seamless resources for pharmaceutical and biotech products — from patient recruitment and retention for clinical trials to late stage studies and health economics and outcomes research, as well as medical communications. Theo-24 Cr (Theophylline ) with free prescription Continuum Clinical provides a unique blend of resources and perspectives, proven expertise, and innovative solutions throughout the entire continuum of a product’s lifecycle — from pre-launch into the real world. Buy Vitamin B6 - Pyridoxine online Headquartered in the US, Continuum Clinical has employees in Europe and expanded worldwide network of resources. WWW.CONTINUUMCLINICAL.COM

Riassunto InnerWorkings fornir`a ad AstraZeneca dei servizi di esecuzione di marketing esclusivi

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JMP Group Announces Addition of Donald Ellis to Equity Research Department

SAN FRANCISCO--(BUSINESS WIRE)--JMP Group LLC (NYSE:JMP), an investment banking and alternative asset management firm, announced today that Donald Ellis has joined JMP Securities as a managing director and equity research analyst covering specialty pharmaceuticals. “Don is a seasoned research analyst with a broad range of experience in the biopharmaceutical industry,” said Thomas Wright, director of equities at JMP Securities. Buy Glucotrol Xl (Glipizide) with no Rx “As a Wall Street veteran, a clinical pharmacologist and an entrepreneur, he is extraordinarily well positioned to provide JMP’s institutional brokerage clients with insight into the specialty pharmaceuticals sector. About Parafon (Chlorzoxazone) without Rx Don’s arrival brings the number of senior equity analysts focused on life sciences at JMP to six and underscores the firm’s commitment to being a leading resource for institutional investors and growth companies in the space.” Prior to joining JMP Securities, Mr. About Kamagra Gold (Sildenafil Citrate) Ellis was a managing director and equity research analyst at Avondale Partners. Dermacort with no prescription Previously, he founded and ran a capital markets consulting firm, after spending 15 years in senior research positions at boutique investment banks Thomas Weisel Partners, Robertson Stephens & Co. Buy Wondersleep () with no Rx and Montgomery Securities. Buy Sleep Aids online Earlier in his career, Mr. http://medical-reviews.blogspot.com Ellis spent 11 years in clinical practice at Kaiser Permanente and the VA Medical Center managing drug therapies and developing novel treatment protocols. He holds an MBA from the University of San Diego and a doctorate degree in pharmacy from the University of Southern California. About JMP Group JMP Group LLC is an investment banking and asset management firm that provides investment banking, equity research, and sales and trading services to corporate and institutional clients as well as alternative asset management products and services to institutional and high-net-worth investors. JMP Group conducts its investment banking and research, sales and trading activities through JMP Securities; its hedge fund and other investment activities though Harvest Capital Strategies; the underwriting and management of investments in senior secured debt through JMP Credit Advisors; and the management of Harvest Capital Credit Corporation (NASDAQ: HCAP), a business development company that finances small and midsized businesses, through HCAP Advisors. For more information, visit .jmpg.com.

Simulations Plus Reports Third Quarter FY2015 Financial Results

LANCASTER, Calif.--(BUSINESS WIRE)--Simulations Plus, Inc. About Cytoxan (Cyclophosphamide) with no Rx (NASDAQ: SLP), the premier provider of simulation and modeling software and consulting services for all phases of pharmaceutical discovery and development from the earliest discovery through all phases of clinical trials, today reported financial results for its third quarter of fiscal year 2015 ended May 31, 2015 (3QFY15), and first nine months of fiscal year 2015 (9moFY15), compared to the third quarter (3QFY14) and first nine months of fiscal year 2014 (9moFY14). 3QFY15 highlights compared with 3QFY14: Net revenues increased 58.9% to $5.94 million, an increase of $2.20 million from $3.74 million Gross profit was up 37.4% to $4.83 million, an increase of $1.31 million from $3.51 million SG&A was $1.62 million, an increase of 34.9% or $420,000 from $1.20 million R&D expenditures were $594,000, an increase of $42,000 or 7.6% over $552,000 In 3QFY15, $246,000 was capitalized and $348,000 was expensed In 3QFY14, $317,000 was capitalized and $235,000 was expensed Income before taxes increased 35.1% to $2.82 million, an increase of $733,000 from $2.09 million Net income increased 41.7% to $1.85 million, an increase of $545,000 from $1.31 million Diluted earnings per share increased 36.5% to $0.108 from $0.079 9moFY15 highlights compared with 9moFY14: Net revenues increased 54.3% to $14.60 million, an increase of $5.14 million from $9.46 million Gross profit was up 37.0% to $11.36 million, an increase of $3.07 million from $8.29 million SG&A was $5.30 million, an increase of $1.92 million or 57.0% from $3.38 million R&D expenditures were $1.96 million, an increase of $154,000, or 8.5% over $1.8 million For 9moFY15, $976,000 was capitalized and $982,000 was expensed For 9moFY14, $1.05 million was capitalized and $751,000 was expensed Income before taxes increased 18.6% to $5.01 million, an increase of $788,000 from $4.23 million Net income increased 19.6% to $3.35 million, an increase of $549,000 from $2.80 million Diluted earnings per share increased 14.6% to $0.196 from $0.171 Mr. Seromycin (Cycloserine) John Kneisel, chief financial officer of Simulations Plus, said: “The Company delivered record results aided by a strong quarter of software sales and consulting revenues. Zero Nicotine () without Rx Year-to-date diluted earnings per share reached the 20c mark. Buy Cytodrox with free prescription After distributing just over $800,000 in dividends during 3QFY15, cash on May 31 was a healthy $6.4 million and is currently at $7.8 million.” Ted Grasela, president of Simulations Plus and its wholly owned subsidiary, Cognigen Corporation, added: “Strong collaborations between our scientists have identified new and innovative ways of using modeling and simulation to bring valuable insights to our clients’ research and development programs. Anaprox (Naproxen) with no Rx The strategic and synergistic benefits of the Cognigen acquisition are being realized and we look forward to finding even more synergies between the talent and technologies of the two Simulations Plus divisions.” Walt Woltosz, chairman and CEO of Simulations Plus and Cognigen, added: “We believe the combined Simulations Plus/Cognigen team, which now spans all aspects of drug development from early discovery chemistry through clinical trials and on to generics, provides the most comprehensive offering of powerful software and consulting expertise available to the pharmaceutical industry today. Buy Protein Bars online We’re realizing the potential we expected from joining the predominantly preclinical and early clinical capabilities of Simulations Plus with the world-class clinical trial data analysis and reporting expertise of Cognigen, with a number of projects now using the expertise from both teams to meet customers’ needs. http://webmdhelper.wordpress.com Scientists from both divisions are learning about the methods used by each other, which will enable them to communicate the advantages of working with our organization as they go out to scientific meetings and conferences, and to provide training at customer sites. We believe this is just the beginning, as more and more managers in drug development are recognizing the tremendous potential of model-based drug development through best-in-class software and top-notch consulting expertise.” Dividend Announcement The Company today announced that its board of directors has declared a quarterly cash dividend of $0.05 per share to its shareholders. This cash dividend will be distributed on Thursday, July 30, 2015, for shareholders of record as of Thursday, July 23, 2015. Investor Conference Call The Company will hold an investor conference call on Monday, July 13, at 1:15 p.m. PT/4:15 p.m. ET. The conference call will be webcast live and may be joined by registering at: attendee.gotowebinar.com/register/7514990819733113602. After registering, you will receive a confirmation email containing information about joining the webinar. Please dial in five to ten minutes prior to the scheduled start time. For listen-only mode, you may dial (415) 655-0059, and enter access code 307-841-003. About Simulations Plus, Inc. and Cognigen Corp. Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation and modeling software which is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, agrochemical, and food industry companies worldwide. Simulations Plus recently acquired Cognigen Corporation of Buffalo, NY, adding to our offerings top-quality statistical modeling and simulation using clinical trial data, as well as more than doubling our staff from 30 to over 60, adding nearly 50% to revenues, and increasing earnings in the fiscal year that began September 1, 2014. The Company is headquartered in Southern California and trades on the NASDAQ Capital Market under the symbol “SLP.” Cognigen Corp. is located in Buffalo, New York. For more information, visit our Web site at .simulations-plus.com. Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the U.S. Securities and Exchange Commission. --Tables follow -- SIMULATIONS PLUS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS As of   (Unaudited)   (Audited) May 31,   August 31, ASSETS 2015 2014 Current assets Cash and cash equivalents $ 6,428,596 $ 8,614,929 Accounts receivable, net of allowance for doubtful accounts of $0 3,990,467 1,708,158 Revenues in excess of billings 924,793 158,914 Prepaid income taxes - 748,359 Prepaid expenses and other current assets 269,776 188,160 Deferred income taxes   209,705   114,846 Total current assets $ 11,823,337 $ 11,533,366 Long-term assets Capitalized computer software development costs, net of accumulated amortization of $7,358,012 and $6,609,283 $ 3,880,162 $ 3,452,541 Property and equipment, net 420,629 95,242 Intellectual property, net of accumulated amortization of $649,375 and $193,750 5,425,625 5,881,250 Other intangible assets net of accumulated amortization of $110,625 1,539,375 - Goodwill 4,789,248 - Other assets   34,082   18,445 Total assets $ 27,912,458 $ 20,980,844   LIABILITIES AND SHAREHOLDERS EQUITY Current liabilities Accounts payable $ 133,126 $ 130,547 Accrued payroll and other expenses 427,750 340,709 Accrued bonuses to officer 72,000 120,000 Income taxes payable 178,894 - Other current liabilities 19,859 19,859 Current portion - Contracts payable 750,000 750,000 Billings in excess of revenues 93,122 - Deferred revenue   42,168   30,370 Total current liabilities $ 1,716,919 $ 1,391,485   Long-term liabilities Deferred income taxes $ 3,510,899 $ 2,375,874 Payments due under Contracts payable 2,854,404 1,750,000 Other long-term liabilities   13,239   28,134 Total liabilities $ 8,095,461 $ 5,545,493   Commitments and contingencies   Shareholders equity Preferred stock, $0.001 par value 10,000,000 shares authorized no shares issued and outstanding $ - $ - Common stock, $0.001 par value 50,000,000 shares authorized 16,887,117 and 16,349,955 shares issued and outstanding $ 5,358 $ 4,821 Additional paid-in capital 9,643,394 6,085,427 Retained earnings   10,168,245   9,345,103 Total shareholders equity $ 19,816,997 $ 15,435,351 Total liabilities and shareholders equity $ 27,912,458 $ 20,980,844   SIMULATIONS PLUS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For the three and nine months ended May 31, (Unaudited)   Three months ended   Nine months ended 2015   2014 2015   2014   Net Revenues $ 5,942,082 $ 3,740,567 $ 14,602,464 $ 9,463,059 Cost of revenues $ 1,115,402     227,600     3,238,796     1,168,219   Gross margin $ 4,826,680     3,512,967     11,363,668     8,294,840   Operating expenses Selling, general, and administrative $ 1,624,610 1,204,312 5,303,792 3,378,950 Research and development $ 348,285     234,685     981,633     750,808   Total operating expenses $ 1,972,895     1,438,997     6,285,425     4,129,758     Income from operations $ 2,853,785     2,073,970     5,078,243     4,165,082     Other income (expense) Interest income $ 4,391 8,017 13,394 25,000 Gain (loss) on currency exchange $ (35,632 )   7,340     (78,107 )   35,477   Total other income (expense) $ (31,241 )   15,357     (64,713 )   60,477   Income from operations before provision for income taxes $ 2,822,544 2,089,327 5,013,530 4,225,559 Provision for income taxes $ (970,122 )   (781,778 )   (1,661,972 )   (1,422,991 ) Net Income $ 1,852,422   $ 1,307,549   $ 3,351,558   $ 2,802,568     Earnings per share Basic $ 0.11 $ 0.08 $ 0.20 $ 0.17 Diluted $ 0.11 $ 0.08 $ 0.20 $ 0.17   Weighted-average common shares outstanding Basic 16,862,128 16,193,976 16,847,191 16,117,198 Diluted 17,073,155 16,455,078 17,070,334 16,361,695