Saginuma Clinic | お店のミカタ https://saginumae.on.omisenomikata.jp/ We have a medicine for patient worldwide. https://asset.omisenomikata.jp/Hp360/e6/1f/912361/912361_6d0f15e61f_header_logo_pc.png Saginuma Clinic https://saginumae.on.omisenomikata.jp/ 【お知らせ】 7min.from Saginuma station on your foot. Sun, 18 Nov 2018 23:00:14 +0900 544143 https://saginumae.on.omisenomikata.jp/ 7min.from Saginuma station on your foot. 【お知らせ】 I will check you in English from 4PM. Sun, 18 Nov 2018 22:59:15 +0900 1891418 https://saginumae.on.omisenomikata.jp/ I will check you in English from 4PM. 【お知らせ】 We will get a Flu.shot from 11/28. Sun, 18 Nov 2018 22:54:53 +0900 1891414 https://saginumae.on.omisenomikata.jp/ We will get a Flu.shot from 11/28. 【お知らせ】 Start for cure hepatitis C patient Thu, 04 May 2017 20:24:13 +0900 588495 https://saginumae.on.omisenomikata.jp/ Start for cure hepatitis C patient 【お知らせ】 Buy medicine at a lower price than USA Thu, 04 May 2017 20:23:49 +0900 1333581 https://saginumae.on.omisenomikata.jp/ Buy medicine at a lower price than USA 【日記】 Good news for patients with familial hyperlipidemia (homozygous patient) Sat, 09 Jul 2016 23:22:23 +0900 1329281 https://saginumae.on.omisenomikata.jp/diary/1329281 We started to medicate&nbsp;PCSK9 inhibitor(Evolocumab) in patients with familial hyperlipidemia (homozygous patient) in our clinic.(information of this&nbsp;medicine is as follows) <br /><a href="http://investors.amgen.com/phoenix.zhtml?c=61656&amp;p=irol-newsArticle&amp;id=1961786">http://investors.amgen.com/phoenix.zhtml?c=61656&amp;p=irol-newsArticle&amp;id=1961786</a><br /><br />You can buy it at a lower price than USA, so&nbsp;launch from 2016.April in Japan,but you need to&nbsp;visit our clinic at least one time.(e.g. visit on a sightseeing trip and/or ask&nbsp;your family&nbsp;to buy in Japan)<br />If you need more information, please send E-mail us.(e.g. How do I get directions from Haneda international airport / Narita international airport)<br /><br /><a href="mailto:saginuma.cl@gmail.com">saginuma.cl@gmail.com</a><br /><br />Price is as follows. <br />Evolocumab(Repatha) / made in Japan<br />SC Injection 140mg Syringe /¥36000円<br />420mg / every 4weeks SC<br /><br /><span>Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA</span> <span><strong>Represents First BLA Submission for a PCSK9 Inhibitor</strong> THOUSAND OAKS, Calif., Aug. 28, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for evolocumab seeking approval for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.1 &shy; The BLA for evolocumab contains data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials. The Phase 3 studies evaluated the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with heterozygous familial hypercholesterolemia (HeFH); and patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder.2 "This BLA submission to the FDA marks the first of several submissions to regulatory authorities around the world for our lipid-lowering program and represents a critical milestone in our overall global development program for evolocumab," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to working closely with regulatory authorities to bring this new treatment option to patients with high cholesterol who, despite currently available therapies, are unable to adequately reduce their LDL cholesterol levels." High cholesterol, particularly elevated LDL-C, is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood.3,4 Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.5,6 Familial hypercholesterolemia (FH) is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age,2 and it is estimated that less than one percent of people with FH (heterozygous and homozygous forms) in the U.S. are diagnosed.7 Patients can have either one of two types of FH.1 Heterozygous FH is the more common type of FH and occurs in approximately one in 200 to 500 people.7 It can cause LDL-C levels twice as high as normal (e.g., &gt;190 mg/dL).8 Individuals with HeFH have one altered copy of a cholesterol-regulating gene.8 Homozygous FH is the rare, more severe form, occurring in approximately one in a million individuals.9 It can cause LDL-C levels more than six times as high as normal (e.g., 650-1,000 mg/dL).9 An individual with HoFH has two altered copies of cholesterol-regulating genes (one from each parent).2 In 2013, the FDA granted evolocumab an orphan drug designation for HoFH. <strong>About Evolocumab</strong> Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.10 Evolocumab, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.1 <strong>About PROFICIO: The Evolocumab Clinical Trial Program</strong> PROFICIO, which stands for the <span style="text-decoration: underline;">P</span>rogram to <span style="text-decoration: underline;">R</span>educe LDL-C and Cardiovascular <span style="text-decoration: underline;">O</span>utcomes <span style="text-decoration: underline;">F</span>ollowing <span style="text-decoration: underline;">I</span>nhibition of P<span style="text-decoration: underline;">C</span>SK9 <span style="text-decoration: underline;">I</span>n Different P<span style="text-decoration: underline;">O</span>pulations, is a large and comprehensive clinical trial program evaluating evolocumab in 22 clinical trials, with a combined planned enrollment of approximately 30,000 patients. The Phase 3 program includes 16 trials to evaluate evolocumab administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2 and YUKAWA-2); in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2 and GAUSS-3); as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2); in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2 and TAUSSIG) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia; the effects of evolocumab on lipoprotein metabolism (FLOREY); and the administration of evolocumab in statin-treated hyperlipidemic patients (THOMAS-1 and THOMAS-2). Five ongoing studies in the evolocumab Phase 3 program will provide long-term safety and efficacy data. These include FOURIER (<span style="text-decoration: underline;">F</span>urther Cardiovascular&nbsp;<span style="text-decoration: underline;">OU</span>tcomes&nbsp;<span style="text-decoration: underline;">R</span>esearch with PCSK9&nbsp;<span style="text-decoration: underline;">I</span>nhibition in Subjects with&nbsp;<span style="text-decoration: underline;">E</span>levated&nbsp;<span style="text-decoration: underline;">R</span>isk), which will assess whether treatment with evolocumab in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease; EBBINGHAUS (<span style="text-decoration: underline;">E</span>valuating PCSK9 <span style="text-decoration: underline;">B</span>inding Anti<span style="text-decoration: underline;">B</span>ody <span style="text-decoration: underline;">I</span>nfluence o<span style="text-decoration: underline;">N</span> Co<span style="text-decoration: underline;">G</span>nitive <span style="text-decoration: underline;">H</span>e<span style="text-decoration: underline;">A</span>lth in High Cardiovasc<span style="text-decoration: underline;">U</span>lar Risk <span style="text-decoration: underline;">S</span>ubjects), which will evaluate the effect of evolocumab on cognitive function in a subset of patients enrolled in FOURIER; OSLER-2 (<span style="text-decoration: underline;">O</span>pen Label <span style="text-decoration: underline;">S</span>tudy of <span style="text-decoration: underline;">L</span>ong T<span style="text-decoration: underline;">ER</span>m Evaluation Against LDL-C Trial-2) in patients with high cholesterol who completed any of the Phase 3 studies; GLAGOV (<span style="text-decoration: underline;">GL</span>obal <span style="text-decoration: underline;">A</span>ssessment of Plaque Re<span style="text-decoration: underline;">G</span>ression with a PCSK9 Antib<span style="text-decoration: underline;">O</span>dy as Measured by Intra<span style="text-decoration: underline;">V</span>ascular Ultrasound), which will determine the effect of evolocumab on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization; and TAUSSIG (<span style="text-decoration: underline;">T</span>rial <span style="text-decoration: underline;">A</span>ssessing Long Term <span style="text-decoration: underline;">US</span>e of PC<span style="text-decoration: underline;">S</span>K9 <span style="text-decoration: underline;">I</span>nhibition in Subjects with <span style="text-decoration: underline;">G</span>enetic LDL Disorders), which will assess the long-term safety and efficacy of evolocumab on LDL-C in patients with severe familial hypercholesterolemia including patients with homozygous familial hypercholesterolemia. The DESCARTES (<span style="text-decoration: underline;">D</span>urable&nbsp;<span style="text-decoration: underline;">E</span>ffect of PC<span style="text-decoration: underline;">S</span>K9 Antibody&nbsp;<span style="text-decoration: underline;">C</span>omp<span style="text-decoration: underline;">AR</span>ed wi<span style="text-decoration: underline;">T</span>h Plac<span style="text-decoration: underline;">E</span>bo <span style="text-decoration: underline;">S</span>tudy) study, a long-term safety and efficacy trial in patients with hyperlipidemia at risk for cardiovascular disease, has been completed, presented and published. <strong>About Amgen's Commitment to Cardiovascular Disease</strong> Amgen is dedicated to addressing important scientific questions in order to advance care and improve the lives of patients with cardiovascular disease. Through its own research and development efforts and innovative partnerships, Amgen has built a robust cardiology pipeline consisting of several investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure. <strong>About Amgen</strong> Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit <a href="http://www.amgen.com/" target="_blank">www.amgen.com</a> and follow us on <a href="http://www.twitter.com/amgen" target="_blank">www.twitter.com/amgen</a>. <strong>Forward-Looking Statements</strong> This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Aug. 28, 2014, and expressly disclaims any duty to update information contained in this news release. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. Cost saving initiatives may result in us incurring impairment or other related charges on our assets. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our recently announced restructuring plans.&nbsp; Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or their ability to pay a dividend or repurchase our common stock. The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. </span> 【Location】 An immediate environment Sat, 07 May 2016 23:44:29 +0900 1336145 https://saginumae.on.omisenomikata.jp/menu/1336145 <a href="https://en.wikipedia.org/wiki/Miyamae-ku,_Kawasaki">https://en.wikipedia.org/wiki/Miyamae-ku,_Kawasaki</a> 【日記】 Good news for patients with hepatitis C (genotype1) Sat, 07 May 2016 22:36:23 +0900 1296046 https://saginumae.on.omisenomikata.jp/diary/1296046 We started to medicate Sofosbuvir (SFV)+Ledipasvir (LDP) in patients with hepatitis C (genotype1)&nbsp;in our clinic.(information of this&nbsp;medicine is as follows) <br /><a href="https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf">https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf</a><br /><br />You can buy it at a lower price than USA, so we have a popular price from 2016.April,but you need to&nbsp;visit our clinic at least one time.(e.g. visit on a sightseeing trip and/or ask&nbsp;your family&nbsp;to buy)<br />If you need more information, please send E-mail us.(e.g. How do I get directions from Haneda international airport / Narita international airport)<br /><br /><a href="mailto:saginuma.cl@gmail.com">saginuma.cl@gmail.com</a><br /><br />Price is as follows. <br />Sofosbuvir (SFV)+Ledipasvir (LDP): Harvoni / made in Japan<br />28tablet ¥1,890,000 (¥67,500/tab)<br />56tablet ¥3,640,000 (¥65,000/tab)<br />84tablet ¥5,250,000 (¥62,500/tab) <br />&nbsp; 【お知らせ】 non-consultation day 8/13~8/15.12/31~1/3 Thu, 07 Apr 2016 23:15:48 +0900 722752 https://saginumae.on.omisenomikata.jp/ non-consultation day 8/13~8/15.12/31~1/3 【クーポン】 Immunization (Influenza) Mon, 20 Jul 2015 22:09:00 +0900 547005 https://saginumae.on.omisenomikata.jp/coupon Immunization (Influenza) 【日記】 Facebook Fri, 25 Oct 2013 23:33:49 +0900 545159 https://saginumae.on.omisenomikata.jp/diary/545159 <span>Saginuma Clinic:Healthcare Corporation Nichibeikai<br /><br />We have a English-speaking doctor in clinic.(Dr.Yukinari)<br />Appointment of Dr.Yukinari is necessary without 4:45pm to 7:45pm<br />If you need more information,please call 044-855-9977 Our staff( <span>Ms.Kinoshita)can speak in English.<br /><br /><a href="https://www.facebook.com/pages/%E9%B7%BA%E6%B2%BC%E8%A8%BA%E7%99%82%E6%89%80/119615161447454" target="_blank">Facebook:</a>in Japanese/English<br /><br />HP:in English<br /><a href="http://saginumae.on.omisenomikata.jp/" target="_blank">http://saginumae.on.omisenomikata.jp/</a><br />MAP:in English <br /><a href="https://maps.google.com/maps?daddr=35.576619834720255,139.57819819450378">https://maps.google.com/maps?daddr=35.576619834720255,139.57819819450378</a></span></span> 【日記】 Twitter Fri, 25 Oct 2013 23:30:57 +0900 550532 https://saginumae.on.omisenomikata.jp/diary/550532 <span>Saginuma Clinic:Healthcare Corporation Nichibeikai<br /><br />We have a English-speaking doctor in clinic.(Dr.Yukinari)<br />Appointment of Dr.Yukinari is necessary without 4:45pm to 7:45pm<br />If you need more information,please call 044-855-9977 Our staff(<span>...</span><span>Ms.Kinoshita)can speak in English.<br /><br /><a href="https://twitter.com/#!/nichibeikai" target="_blank">Twitter</a>: in Japanese/English<br /><br />HP:in English<br /><a href="http://saginumae.on.omisenomikata.jp/" target="_blank">http://saginumae.on.omisenomikata.jp/</a><br />MAP:in English <br /><a href="https://maps.google.com/maps?daddr=35.576619834720255,139.57819819450378">https://maps.google.com/maps?daddr=35.576619834720255,139.57819819450378</a></span></span> 【Academics】 Literature Sun, 20 Oct 2013 14:40:37 +0900 546995 https://saginumae.on.omisenomikata.jp/menu/546995 <a href="http://saginuma.client.jp/saginuma/html/index7.html" target="_blank">Literature: in Japanese / English<br /></a><br /><a href="http://www.ncbi.nlm.nih.gov/pubmed/16621999?dopt=Abstract">http://www.ncbi.nlm.nih.gov/pubmed/16621999?dopt=Abstract</a><br /><br /><a href="http://www.ncbi.nlm.nih.gov/pubmed/1588739?dopt=Abstract">http://www.ncbi.nlm.nih.gov/pubmed/1588739?dopt=Abstract</a><br /><br /><a href="http://www.ncbi.nlm.nih.gov/pubmed/1588759?dopt=Abstract">http://www.ncbi.nlm.nih.gov/pubmed/1588759?dopt=Abstract</a><br /><br /><a href="http://www.ncbi.nlm.nih.gov/pubmed/9442598?dopt=Abstract">http://www.ncbi.nlm.nih.gov/pubmed/9442598?dopt=Abstract</a>