Monday, August 4, 2014

Certara Launches D360 in Japan to Improve Drug Discovery and Development Productivity


TOKYO & ST. LOUIS--(BUSINESS WIRE)--Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced the launch in Japan of D360, its integrated solution for the query, analysis and visualization of drug discovery and development data. D360 is used by scientists in both discovery and pre-clinical research. It allows them to search, analyze and share their data without the need for constant IT support, helping to shorten the drug discovery cycle. In preclinical drug discovery, searching historical control data to answer questions from regulatory agencies often requires the manual review of multiple study reports, which can entail days or weeks of effort. With D360, scientists can obtain the necessary cross-study data views in minutes, allowing them to provide an immediate response to regulatory bodies, and avoiding costly delays in approval processes and disruptions to ongoing work. In early phase discovery research, scientists use D360 to get a comprehensive view of all project-relevant data, in which data summarization is performed, according to corporate standard scientific business rules, at the click of a button. Decision making at project meetings becomes more efficient since the effort required for data collation is practically eliminated. Consistent data presentation minimizes discussion about data collation methods, and the ability to drill down on aggregated data and use follow-on queries allows supporting information to be obtained in situ. “We are proud to introduce D360 to the Japanese market,” said Certara CEO Edmundo Muniz, M.D., Ph.D. “D360 is a well-established, trusted drug discovery and development data access and analysis solution that can help pharma and biotech companies to improve the time to and accuracy of their go/no-go product decisions by providing scientists with on-demand access to their desired data in their preferred format.” D360 is already deployed in life sciences research organizations of all sizes including six top 15 pharma companies. D360 is being used by a variety of disciplines at organizations such as Pfizer, Boehringer Ingelheim, Medivir AB, Plexxikon, and Agios to provide: one-click access to project data views for discovery scientists; ad-hoc query capabilities for molecular design and hypothesis testing; real-time preclinical study monitoring; and cross-study analysis of pre-clinical data. Certara currently has more than 200 clients in Japan, including all the top 20 Japanese pharmaceutical companies. D360 will be deployed and supported by the Certara KK office in Tokyo, which was established in 2011. About Certara Certara is the leading global technology-enabled drug development and drug safety consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit .certara.com.

Allied Minds and Bristol-Myers Squibb Form New Enterprise to Advance Discoveries of Biopharmaceutical Innovations at Leading U.S. Academic Research Institutions


BOSTON & NEW YORK--(BUSINESS WIRE)--Allied Minds (LSE: ALM) and Bristol-Myers Squibb Company (NYSE: BMY) today announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the U.S. Allied-Bristol Life Sciences LLC will focus on efficiently and effectively converting discoveries from university research institutions into therapeutic candidates for clinical development, and ultimately approved therapies that address serious diseases. For programs identified by the new enterprise, university researchers will be able to access Bristol-Myers Squibb’s drug discovery research expertise, and Allied Minds’ financial and management experience. “The innovations developed in U.S. research institutions represent an important resource for scientific advancement, as well as economic development and financial returns,” said Chris Silva, Chief Executive Officer of Allied Minds. “Our partnership with Bristol-Myers Squibb combines complementary strengths, resources, reach and expertise to create an exciting new paradigm in the drug development space.” “Allied-Bristol Life Sciences LLC brings together cutting-edge ideas, BioPharma experience and drug discovery expertise focused on maximizing the potential of new scientific approaches to addressing serious disease,” said Carl Decicco, senior vice president and Head of Discovery, Bristol-Myers Squibb. “We believe this new venture will enhance the translation of early-stage academic research and will ultimately help advance important potential new medicines more efficiently.” Under the terms of the agreement, the companies have jointly formed and funded Allied-Bristol Life Sciences LLC, which will work with university researchers to identify discoveries it believes has promising therapeutic and commercial potential, and will support the research and development needed to take these early-stage opportunities from initial feasibility to pre-clinical candidacy. Allied Minds and Bristol-Myers Squibb together will form and fund new companies to conduct feasibility and full-phase discovery programs. Once a program succeeds in identifying a pre-clinical candidate, Bristol-Myers Squibb will have the option to acquire the company from Allied-Bristol Life Sciences LLC under pre-agreed terms. About Allied Minds Allied Minds (LSE: ALM) is an innovative U.S. science and technology development and commercialization company. Operating since 2006, the company forms, funds, manages and builds products and businesses based on innovative technologies developed at leading U.S. universities and federal research institutions. Allied Minds serves as a diversified holding company that supports its businesses and product development with capital, central management and shared services. More information about the Boston-based company can be found at .alliedminds.com. Allied Minds’ investment model is to form, fund, manage and build companies and jobs for the long term. The company takes a majority ownership stake in each business it establishes, and provides funding and central management so that it’s intimately involved at each stage of strategy and growth. Allied Minds currently works with more than 33 leading universities, several of which exceed $1 billion each in annual research spending, as well as 32 federal research centers and laboratories managed by the U.S. Departments of Defense and Energy on a similar commercialization structure. It currently has 18 operating companies in the U.S. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit .bms.com or follow us on Twitter at twitter.com/bmsnews. Allied Minds Forward-Looking Statement This press release contains statements that are or may be forward-looking statements, including statements that relate to the company’s future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risk and uncertainties described in the risk factors included in the company’s regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law, regulatory requirement, the Prospectus Rules, the Listing Rules and the Disclosure and Transparency Rules, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Bristol-Myers Squibb Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the programs mentioned in this release will lead to identifying a pre-clinical candidate. Nor is there any guarantee that if one is identified, Bristol-Myers Squibb will exercise its option to acquire it, or that it will lead to an approved product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb s Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Medivir licenses Respiratory Syncytial Virus drug program from Boehringer Ingelheim


HUDDINGE, Sweden--(BUSINESS WIRE)--Regulatory News: Medivir AB (STO:MVIR-B) today announces that it has entered a license agreement with Boehringer Ingelheim International GmbH for exclusive, global rights to a drug program for the treatment and prevention of Respiratory Syncytial Virus (RSV) infection. “RSV is respiratory pathogen that can cause life-threatening infections, especially in children, the elderly and the immunocompromised. It is a major, underserved disease area today, with no effective treatment available” said Maris Hartmanis, Medivir’s CEO. “The in-licensing of this program illustrates Medivir’s strategic intent to enhance its R&D pipeline with high-value, commercial opportunities.” The program includes novel compounds that inhibit the RSV fusion protein, which is a key mediator of viral entry into host cells and a target for new medicines. About Coumadin (Warfarin) “We are very pleased to have secured this program from Boehringer Ingelheim and to have the opportunity to build upon the impressive research already conducted” said Richard Bethell Medivir’s EVP, Discovery Research. Buy Cozaar (Losartan) “We can now look forward to advancing potential new drugs for the benefit of vulnerable patients.” Under the terms of the agreement Medivir receives an exclusive, global license to research, develop, manufacture and commercialise RSV drugs resulting from Boehringer Ingelheim’s program. Compazine (Prochlorperazine) Boehringer Ingelheim receives an upfront payment and future success milestones as well as royalties on sales. About RSV Human respiratory syncytial virus is the main viral cause of respiratory tract infection in infants, the elderly and the severely immunocompromised. About Deltasone with free Rx Almost all children will have been infected with RSV by the time of their second birthday. Buy Separation Anxiety online It has been estimated that RSV resulted in around 33.8 million lower respiratory tract infections in children younger than 5 years in 2005, with 3.4 million requiring hospitalization and between 66,000 and 199,000 child deaths (Nair et al. http://medicalhelper.wordpress.com 2010). Today only one drug is approved for therapeutic use – ribavirin – but its use is limited by a complex administration procedure, limited efficacy, high cost and toxic side effects. A humanised monoclonal antibody is available for prophylatic use, but it is approved only for prevention of RSV infection in infants that are at very high risk of serious lower respiratory tract disease following infection by RSV. Patients urgently need new, safe and effective drug options for the treatment and prevention of RSV infection. About Medivir Medivir is an emerging and profitable research-based pharmaceutical company with an established marketing and sales organisation in the Nordics with a broad portfolio of prescription pharmaceuticals. Medivir receives royalty from Johnson & Johnson global sales of the hepatitis C pharmaceutical Olysio. In addition, revenues for sales of Olysio in the Nordic region is generated through the companies own sales and marketing organisation. Medivir’s research and development portfolio of pharmaceuticals is based on the company’s expertise in polymerase and protease drug targets for different disease areas. The company’s current research and development is focused on infectious diseases, bone related disorders, neuropathic pain and oncology. Medivir is listed on the Nasdaq OMX Mid-Cap list. This information was brought to you by Cision news.cision.com

Thursday, July 24, 2014

Research and Markets 2014 US Pharmaceutical Companies Contacts Directory - 2,658 companies & 5000+ Contacts


. http://medicalhelper.wordpress.com Buy Protein Foods online Buy Cytotam without Rx About Calan (Verapamil) About Calan Sr (Verapamil) without prescription Calan (Verapamil) with no Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/tnlkdd/us_pharmaceutical) has announced the addition of the "US Pharmaceutical Companies

Friday, July 18, 2014

DesignMedix Closes Second Angel Round of $1.5 Million


PORTLAND, Ore.--(BUSINESS WIRE)--DesignMedix, Inc., a biotech startup with ties to Portland State University, has closed a second round of angel funding from investors in the Northwest. Investors include Portland Seed Fund, as well as members of Bellingham Angels, Oregon Angel Fund, Seraph Angel Network, Willamette Angel Conference, Keiretsu Angel Forum and Tacoma Angel Network. “The funds will help to support further development of a pipeline of drugs that combat drug resistance, including malaria drugs and new anti-bacterial drugs,” said Dr. Sandra Shotwell, president and COO of DesignMedix. Buy Viagra Super Force (Sildenafil Citrate + Dapoxetine) without prescription “Drug resistance is a severe global health problem that is considered a significant threat to human health worldwide, according to the World Health Organization and the Centers for Disease Control.” DesignMedix has exclusive rights to four issued patents relating to drug candidates for malaria drugs. Buy Levitra Soft (Vardenafil) with no prescription The company’s lab and office are housed in the PSU Business Accelerator. Most current therapies for malaria and common bacterial diseases show drug resistance, and the cost for treating patients has greatly increased. About Ziagen (Abacavir) with no Rx DesignMedix focuses on overcoming drug resistance to create effective drugs for malaria and other diseases. Buy Colchicum without prescription The company was recently awarded a $3 million grant from the National Institutes of Health to support preclinical development of its malaria drug. Buy Natural Skin Care Products online This grant is designed to carry the drug forward to human clinical studies. http://medicalhelper.wordpress.com The recent investment will supplement this drug development program, and support expansion into other disease areas. About DesignMedix Inc. DesignMedix, Inc. was founded in 2008 to develop drugs to overcome drug resistance. The company’s initial focus is on oral drugs to treat malaria, which kills over 600,000 people per year and affects up to 500 million people. The company has developed a series of novel, safe and effective drugs that have the potential for low-cost production. For more information please visit .designmedix.com.

Monday, July 14, 2014

Synergy Pharmaceuticals Reaches Halfway Mark for the First Pivotal Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation


NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that it has reached the halfway mark for total enrollment in the first pivotal phase 3 trial of plecanatide in patients with chronic idiopathic constipation (CIC). The trial is currently being conducted at 180 sites and has randomized approximately 675 CIC patients. This is the first of two ongoing pivotal phase 3 trials designed to confirm the efficacy and safety of both 3.0 mg and 6.0 mg plecanatide doses versus placebo in CIC patients. Buy Viagra Super Force (Sildenafil Citrate + Dapoxetine) without prescription Synergy announced the initiation of its second phase 3 CIC trial in April 2014. The Company plans to release top-line data from the first phase 3 CIC trial in the second quarter of 2015. Buy Levitra Soft (Vardenafil) with no prescription For more information on this trial, please visit clinicaltrials.gov/ct2/show/NCT01982240?term=plecanatide&rank=2 About Plecanatide Plecanatide is Synergy’s lead uroguanylin analog in late-stage clinical development to treat patients with CIC and IBS-C. About Ziagen (Abacavir) with no Rx Uroguanylin is a natural gastrointestinal (GI) hormone produced by humans in the small intestine and plays a key role in regulating the normal functioning of the digestive tract through its activity on the guanylate cyclase-C (GC-C) receptor. Buy Colchicum without prescription The GC-C receptor is known to be a primary source for stimulating a variety of beneficial physiological responses. Buy Natural Skin Care Products online Orally administered plecanatide mimics uroguanylin s functions by binding to and activating the GC-C receptor to stimulate fluid and ion transit required for normal bowel function. http://medicalhelper.wordpress.com Synergy has successfully completed a phase 2b trial of plecanatide in 951 patients with CIC and is currently enrolling patients in two pivotal phase 3 CIC trials. The company also recently announced positive top-line data results from a phase 2b dose-ranging study with plecanatide in patients with IBS-C. Synergy plans to initiate its pivotal phase 3 IBS-C program in the fourth quarter of 2014. About Synergy Pharmaceuticals Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical company focused on the development of novel therapies based on the natural human hormone, uroguanylin, to treat GI diseases and disorders. Synergy has created two unique analogs of uroguanylin – plecanatide and SP-333 – designed to mimic the natural hormone’s activity on the GC-C receptor and target a variety of GI conditions. SP-333 is currently in phase 2 development for opioid-induced constipation and is also being explored for ulcerative colitis. For more information, please visit .synergypharma.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy s Form 10-K for the year ended December 31, 2013 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Thursday, July 10, 2014

OPKO's Long-Acting Clotting Factor VIIa-CTP Receives Positive Opinion For Three Orphan Drug Designations in Europe


MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK) today announced that the European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the approval of orphan drug designation for OPKO s long-acting version of clotting Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX and congenital Factor VII deficiency. These patients are currently being treated by commercially-available Factor VIIa, with estimated 2013 worldwide sales of $1.7 billion. Factor VIIa-CTP already obtained orphan status in the U.S. earlier this year. Currently, Factor VIIa therapy is available only as an intravenous (IV) formulation, which requires multiple injections to treat a bleeding episode due to Factor VIIa’s short half-life. Omnicef (Cefdinir) In addition, the requirement for multiple weekly injections can be onerous for patients interested in preventative prophylactic treatment of the disease, especially children. Preclinical data previously presented by OPKO show that OPKO’s long-acting Factor VIIa-CTP has demonstrated the potential for substantial improvement of the quality of life of patients, via both IV and subcutaneous (SC) administration. About Optivar (Azelastine) with free prescription The combination of a long-acting Factor VIIa coupled with SC administration using a simple injection would potentially change the Factor VIIa market segment, allowing children and adults with hemophilia to be easily self-administered at home on a prophylactic basis. Dr. About Neurontin (Gabapentin) without Rx Phillip Frost, CEO of OPKO, commented, “We are pleased that the COMP will recommend orphan designation for Factor VIIa-CTP in the EU, as it would allow OPKO 10 years of marketing exclusivity upon commercialization of the drug. Buy Cardizem We have previously presented data in animal models of hemophilia showing that Factor Vlla-CTP demonstrates superiority of key efficacy and safety parameters compared to current Factor VIIa products. Buy Hayfever online We are excited about the potential for SC administration. http://allegra-opinion.blogspot.com This may represent another major competitive advantage for our long-acting Factor Vlla-CTP. We expect to initiate a Phase IIa clinical trial with our IV formulation in hemophilia patients in late 2014. We believe that we are in a unique position to be first to market with a long acting Factor VII-a therapy.” This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product development efforts and other non-historical facts about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects, including statements regarding our expectations about our long-acting version of clotting Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX, whether Factor VIIa-CTP has the potential for substantial improvement of the quality of life of patients, via both IV and subcutaneous (SC) administration, whether Factor VIIa-CTP will be able to be administered subcutaneously using a simple injection and allow children and adults with hemophilia to easily self-administer the drug at home on a prophylactic basis, whether we will be able to initiate a Phase IIa trial with our IV formulation in hemophilia patients in late 2014, whether we will be in a position to be first to market with a longer acting Factor VIIa product, expectations about market potential for Factor VIIa-CTP, whether we will be able to successfully develop, obtain approval for and launch sales of the Factor VIIa-CTP, and the expected completion dates for our trials. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that clinical trials for Factor VIIa-CTP may not be successful or achieve the expected results or effectiveness, and may not generate data that would support the approval or marketing of this product for the indications being studied, that others may develop products which are superior to Factor VIIa-CTP, and that Factor VIIa-CTP may not have advantages or prove to be superior over presently marketed products. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Tuesday, July 8, 2014

Iroko Pharmaceuticals Announces First International Filing for ZORVOLEXВ®

Iroko Pharmaceuticals Announces First International Filing for ZORVOLEXВ®


PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced the company affiliate’s first regulatory submission outside of the United States for ZORVOLEX® (diclofenac) capsules. A new drug application was filed for the nonsteroidal anti-inflammatory drug (NSAID) with the Republic of Lebanon Ministry of Public Health (MOPH). ZORVOLEX was approved by the U.S. Food and Drug Administration (FDA) in October 2013 for the treatment of mild to moderate acute pain in adults and is not currently approved for marketing in any other country. A supplemental New Drug Application seeking approval for osteoarthritis pain is currently being reviewed by FDA. “The first ZORVOLEX filing outside of the United States is a tremendous milestone for our company, building on a very busy first half of 2014, which included the ZORVOLEX U.S. launch, FDA approval of our second low dose NSAID and receipt of critical patents for both products,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. This filing was the result of a licensing agreement signed late last year by the company’s affiliate, Iroko Pharmaceuticals Inc., and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to market and sell ZORVOLEX to countries in the Middle East and North Africa (MENA). “We are pleased with this first milestone to come from our partnership with Iroko and look forward to bringing this low dose NSAID option to patients and prescribers throughout the MENA region,” said Selim Ghorayeb, CEO of Algorithm. Iroko will continue to retain all marketing rights to ZORVOLEX in the United States, and is in discussions with additional companies to bring ZORVOLEX to other international markets. ZORVOLEX has been available in U.S. pharmacies since January of this year, and has since seen continuing growth in prescriptions. “We are delighted to see the first fruits of our partnership with Algorithm and are looking forward to expanding access to ZORVOLEX and eventually, other products from our low dose SoluMatrix® NSAID portfolio, across the MENA region and the rest of the world,” said Osagie Imasogie, Executive Chairman of the Board, Iroko Pharmaceuticals. About ZORVOLEX ZORVOLEX is the first low dose FDA-approved NSAID developed using proprietary SoluMatrix Fine Particle Technology™ that is now available by prescription. ZORVOLEX contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. ZORVOLEX was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. ZORVOLEX is not approved for the treatment of osteoarthritis pain. A supplemental New Drug Application seeking approval for this indication is currently being reviewed by FDA. For more information, visit .ZORVOLEX.com. ZORVOLEX is indicated for the treatment of mild to moderate acute pain in adults. Important Safety Information about ZORVOLEX Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. ZORVOLEX is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ZORVOLEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Elevation of one or more liver tests may occur during therapy with ZORVOLEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX. ZORVOLEX should be discontinued immediately if abnormal liver tests persist or worsen. NSAIDS, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists. Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX should be used with caution in patients with fluid retention or heart failure. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors. Treatment with ZORVOLEX in patients with advanced renal disease is not recommended. Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX and should be discontinued immediately if an anaphylactoid reaction occurs. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens – Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if rash or other signs of local skin reaction occur. Starting at 30 weeks gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding higher than users of either drug alone. Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, flatulence, pain in extremity, and dyspepsia. ZORVOLEX capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX. Please see full Prescribing Information for additional important safety and dosing information. About Algorithm S.A.L. Algorithm, a Lebanon-based pharmaceutical manufacturer, is actively present in the MENA region and Cyprus. Algorithm is dedicated to offering quality products, either under license from reputable international companies or developed by the company’s product development team. The portfolio consists of innovative products as well as differentiated generics, focusing mainly on the following therapeutic areas: Cardiometabolic Diseases, Ortho-Rheumatology, Neurology, Onco-Hematology, Endocrinology, Uro-Gynecology, and Dermatology. For more information, visit .algorithm-lb.com/en_Home. About Iroko Pharmaceuticals, LLC Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products. In addition to the Iroko products that are marketed worldwide, the company has a robust pipeline of investigational low dose NSAID products being developed using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™. For more information, visit .iroko.com. SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs. SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko.

RegeneRx’s Strategic Partner G-treeBNT Preparing for Phase III Dry Eye Trials in Asia with RGN-259


ROCKVILLE, Md.--(BUSINESS WIRE)--RegeneRx Pharmaceuticals (OTCBB:RGRX), and G-treeBNT Co. Ltd., a Korean biotech firm, jointly announced today that G-treeBNT is preparing to file an IND and sponsor a Phase III clinical trial with RGN-259 (a Thymosin Beta 4–based preservative-free eye drop) in patients with moderate to severe dry eye initially in South Korea, followed by Japan and Australia, with follow-on registrations in certain additional Asian and Pacific Rim countries if appropriate. The proposed Phase lll trial is based on data generated in a 72-patient, double-masked, placebo-controlled trial sponsored by RegeneRx and conducted by Ora, Inc., an ophthalmic CRO in the U.S. and Japan, as well as data generated in a recently completed 9-patient physician-sponsored, double-masked, placebo-controlled clinical trial in patients with severe dry-eye syndrome, both conducted in the U.S. Both Phase II trials resulted in statistically significant sign and symptom improvements in central cornea staining and ocular discomfort. In the 72-patient trial in the U.S., patients were diagnosed with moderate dry eye, treated with RGN-259 or placebo four times daily for 28 days, and evaluated using Ora’s proprietary controlled adverse environment (CAE) model. RGN-259 was found to be safe and well-tolerated and patients had statistically significant improvements in several signs and symptoms of dry eye at several time points during the study, offering protective effects when patients were “challenged” in the CAE model. In a 9-patient severe dry eye study conducted at the Kresge Eye Institute in Detroit, RGN-259 was found to be safe and well-tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at various time intervals, including 28 days post-treatment, which is consistent with the potentially protective effects observed in the Ora study. The reduction of fluorescein staining is indicative of a reduction in ocular surface damage of the cornea while improvement in ocular discomfort reflects how the patient’s eye feels. The effects of RGN-259 were seen relatively quickly and there were no adverse events associated with the drug in Phase II. These results reflect the known mechanisms of action of RGN-259. “With two RGN-259 Phase II dry eye trials completed in the U.S., we are very pleased that our strategic partner, G-treeBNT, intends to move into Phase III,” stated J.J. Finkelstein, president & chief executive officer of RegeneRx Biopharmaceuticals. “We have been working closely with G-treeBNT on the development of RGN-259 and a successful Phase III clinical trial in Asia would be a critical milestone as G-treeBNT has the rights to commercialize RGN-259 in 28 countries in Asia and Pacific Rim including South Korea, Japan and Australia.” “We have decided to initially file an IND for a Phase III clinical trial with RGN-259 in South Korea, followed by a similar strategy in Japan and Australia. If successful, this will facilitate the commercialization of RGN-259 in other countries in Asia and the Pacific Rim that are covered by our strategic partnership with RegeneRx. Our target is to submit an IND for Phase III within 2014 in order to achieve the first patient recruitment before the end of the first quarter of 2015,” stated Won S. Yang, president and chief executive officer of G-treeBNT. About RegeneRx Pharmaceuticals, Inc. RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the EU, and has an extensive worldwide patent portfolio covering its products. Recently, RGN-259, the Company’s ophthalmic drug candidate has been designated as an orphan drug for the treatment of neurotrophic keratopathy, which is the primary focus of RegeneRx’s clinical development efforts in the U.S. For additional information about RegeneRx please visit .regenerx.com About G-treeBNT Co. Ltd. G-treeBNT (formerly “Digital Aria”) is one of the major players in the IT software industry in Korea since 2000, and based on a foundation of distinguished success achieved in the IT software market, G-treeBNT made a key strategic decision in 2013 to participate in the innovative biopharmaceutical business through carefully selected strategic alliances with distinguished leading bio-venture companies in the US and EU. The strategic alliance with RegeneRx is the first strategic investment in its progressive challenge to create a multi-national biopharmaceutical company. Currently the company is developing an innovative pipeline for dry eye syndrome in 28 Asian and Pacific Rim countries by preparing for Phase III clinical trials while developing a second product in the U.S. for the orphan indication, Epidermolysis Bullosa. About RGN-259 for the Treatment of Dry Eye Syndrome RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on two Phase II clinical trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. The results from these trials reflect RGN-259’s mechanisms of action, appear to support the “protective” effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials. Forward-Looking Statements Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements, such as the filing of a Phase III IND by G-treeBNT or development of RGN-259 in Asia, involves speculation and uncertainties that may or may not prove to be accurate and may be materially different from any results or timing implied by such forward-looking statements. Please view these and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2013, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, including information provided by G-treeBNT, except as required by applicable law.

Monday, July 7, 2014

Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, DaklinzaВ® (daclatasvir) and SunvepraВ® (asunaprevir) Dual Regimen

Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, DaklinzaВ® (daclatasvir) and SunvepraВ® (asunaprevir) Dual Regimen


PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. “Japan has a unique hepatitis C patient population, many of whom are older and have been unable to take, or respond to, traditional therapies, so we have a real sense of urgency to treat these patients now,” said a lead study investigator Kazuaki Chayama of Hiroshima University in Japan. “The approval of the Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients.” Of the 1.2 million people living with HCV in Japan, approximately 70% have genotype 1b. Further, a significant number of patients with HCV in Japan are over the age of 65, leading to more disease-related complications and a decreased likelihood of tolerating interferon-based therapies, the historical standard of care for treating HCV. “The approval of Daklinza+Sunvepra in Japan reflects our strategic focus on developing a treatment option that meets the needs of the Japanese HCV patient population,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “This milestone underscores the company’s commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally.” The Daklinza+Sunvepra Dual Regimen The indications for Daklinza and Sunvepra in Japan are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: (1) patients who are ineligible or intolerant to interferon-based therapy, and (2) patients who have failed to respond to interferon-based therapy. The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 (sustained virologic response 24 weeks after the end of treatment; a functional cure) among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years of age or older who were either interferon-ineligible or intolerant, 91.9% achieved SVR24. Further, patients with compensated cirrhosis present at baseline had overall SVR24 rates of 90.9%. The regimen used in the Phase III study resulted in low rates of discontinuation (5%) due to adverse events (AEs). In addition, the rate of serious adverse events (SAEs) was low (5.9%) and few SAEs were experienced by more than one patient. Nasopharyngitis was the most common AE in the study (30.2%). Results from the HALLMARK-Dual study, the Phase III multinational clinical trial investigating the Daklinza+Sunvepra Dual Regimen among genotype 1b HCV patients, demonstrated similar results to the Japan registration study and support filings in countries that have a high prevalence of genotype 1b, such as Korea and Taiwan. About Bristol-Myers Squibb’s HCV Portfolio Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir, a potent pan-genotypic NS5A complex inhibitor (in vitro), which continues to be investigated in multiple treatment regimens and in people with co-morbidities, and is undergoing regulatory review in the U.S. and Europe. Daclatasvir is being studied in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program. In 2014, the U.S. Food and Drug Administration (FDA) granted Bristol-Myers Squibb’s investigational Daclatasvir+Asunaprevir Dual Regimen Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection. In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing. About Hepatitis C Globally, there are 150 million people infected with HCV, with genotype 1 being the most prevalent. Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, 20 percent of people with chronic hepatitis C will develop cirrhosis and, of those, about 5 to 7 percent of patients may ultimately die of the consequences of infection. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit .bms.com or follow us on Twitter at twitter.com/bmsnews. Bristol-Myers Squibb Forward Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that daclatasvir or asunaprevir or any other compounds mentioned in this release will receive regulatory approval in other countries or that they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb s Annual Report on Form 10-K for the year ended December 31, 2013, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Thursday, July 3, 2014

Research and Markets Spain Sickle-Cell Disorders Market Highlights - 2014


DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/xjmkb3/spain_sicklecell) has announced the addition of the "Spain Sickle-Cell Disorders Market Highlights - 2014" report to their offering. The latest research, Spain Sickle-Cell Disorders Market Highlights - 2014 , provides Spain sickle-cell disorders market analysis, competitive landscape, and sickle-cell disorders drug sales forecast in Spain. The research includes Spain sickle-cell disorders market size estimates for 2013, market share forecast for six years to 2019, sickle-cell disorders drugs market share, sickle-cell disorders drugs sales estimates, sickle-cell disorders drugs sales forecast, and sickle-cell disorders late stage pipeline products. This research helps executives track competitor drugs sales and market share in Spain sickle-cell disorders market. It supports decision making in R&D to long term marketing strategies. The report can be used for evaluating business opportunities, formulating business development strategies, and product positioning in the Spain sickle-cell disorders market. Highlights of the Research: Marketed Sickle-Cell Disorders Drugs in Spain Spain Sickle-Cell Disorders Market Analysis Sickle-Cell Disorders Drugs Sales Analysis in Spain Competitive Landscape in Spain Sickle-Cell Disorders market Sickle-Cell Disorders Late Stage Pipeline Spain Sickle-Cell Disorders Market Forecast Sickle-Cell Disorders Drugs Sales Forecast in Spain Future Competitive Landscape Key Topics Covered: 1. Sickle-Cell Disorders - Disease Definition 2. Marketed Sickle-Cell Disorders Drugs in Spain 3. Spain Sickle-Cell Disorders Market Analysis 4. Competitive Landscape in Spain Sickle-Cell Disorders Market 5. Spain Sickle-Cell Disorders Market - Future Market Outlook 5a. Spain Sickle-Cell Disorders Market Size Forecast 5b. Drug Sales Forecast in Spain Sickle-Cell Disorders Market 5c. Drugs Market Share in Spain Sickle-Cell Disorders Market For more information visit .researchandmarkets.com/research/xjmkb3/spain_sicklecell

Wednesday, July 2, 2014

Professions slam Woolies

Professions slam Woolies


. http://webmdreview.wordpress.com Buy Age - Brown Spots online Buy Abamune with free prescription Advair Diskus (Fluticasone, Salmeterol) Buy Advair Diskus (Fluticasone-Salmeterol) with no Rx Adalat Cc (Nifedipine) without prescription permarket giant Woolworths has come under a barrage of attack from the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia (PSA) and the Australian Medical Association (AMA) for a new “health checks” program for customers - in aisles surrounded by sugary foods, alcohol, high fat snacks and cigarettes. The controversial service, which is being trialled in six stores in NSW and Queensland, employs whitecoated nurses, pharmacy students and graduating pharmacists (pictured) to conduct free blood pressure and cholesterol tests in front of branded pain therapy displays. The PSA, Guild ...

Tuesday, June 17, 2014

PsiOxus Therapeutics Initiates ‘OCTAVE’ Ovarian Cancer Study for Oncolytic Vaccine Enadenotucirev

 PsiOxus Therapeutics Ltd. (PsiOxus), an award-winning biotechnology company developing innovative new treatments for cancer, today announced the first dosing of a patient in the OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) study. OCTAVE is a phase I/II clinical trial to assess the safety and efficacy of its oncolytic vaccine enadenotucirev (previously known as ColoAd1) in platinum-resistant ovarian cancer patients at multiple UK cancer centres beginning this month. About Moduretic (Amiloride-Hydrochlorothiazide) without prescription Enadenotucirev has shown potent, broad-spectrum, anti-cancer activity pre-clinically and is also in phase I/II clinical trials in patients with colorectal tumours.
“Our enadenotucirev oncolytic vaccine has enormous potential to treat a broad spectrum of solid cancer types and starting this OCTAVE study is a key milestone as we progress towards demonstrating its effectiveness in a second form of cancer with a very significant unmet medical need.”
The OCTAVE study will examine the safety, tolerability, pharmacokinetics and efficacy of administering the vaccine directly into the abdomen of cancer patients, where ovarian cancer tends to recur (a process known as intra-peritoneal or IP delivery). About Motilium (Domperidone) without Rx The phase I component of the study will determine the dose of enadenotucirev to be used alone or in combination with paclitaxel. The phase II component will be an open label dose expansion of the combination regimen of enadenotucirev and paclitaxel to determine whether this combination has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian cancer.
Dr Iain McNeish, MD, Professor of Gynaecological Oncology at the Institute of Cancer Sciences at the University of Glasgow, is the principal investigator of the OCTAVE study. About Duricef (Cefadroxil) with no prescription The trial is co-funded by a £1.7 million grant awarded to PsiOxus by the UK government-backed Biomedical Catalyst. This programme is designed to deliver growth to the UK life sciences sector and run jointly by the UK’s innovation agency, the Technology Strategy Board, and the Medical Research Council.
PsiOxus CEO Dr John Beadle commented: “Our enadenotucirev oncolytic vaccine has enormous potential to treat a broad spectrum of solid cancer types and starting this OCTAVE study is a key milestone as we progress towards demonstrating its effectiveness in a second form of cancer with a very significant unmet medical need.”
Enadenotucirev was originally developed using a directed evolution process, with the aim of generating an entirely novel virus with optimised cancer-lytic properties. About Acular with no prescription It has been shown to have little or no activity in normal cells whilst keeping a very high level of anti-cancer potency. As well as assessing how effective intraperitoneal enadenotucirev is for treating ovarian cancer, PsiOxus is also carrying out clinical studies evaluating its safety and efficacy via intravenous injection in patients with colorectal cancer. The phase I/II EVOLVE study (EValuating OncoLytic Vaccine Efficacy) is currently underway and has shown some promising early results.
About PsiOxus Therapeutics, Ltd.
PsiOxus Therapeutics is an Oxford, UK-based development stage biotechnology company using non-traditional approaches to develop novel therapeutics that address cancer and other clinically unmet diseases. Enadenotucirev is an oncolytic vaccine for the systemic treatment of metastatic cancer, which has demonstrated exceptional anti-cancer properties in late pre-clinical development and is now in phase II clinical development. Buy Vitamins online MT-102 is a dual action Anabolic Catabolic Transforming Agent (ACTA) in phase II clinical development for the treatment of cachexia and sarcopenia. The Company is also developing the research phase adjuvant and immunotherapeutic platform PolyMAP, which combines polymers with synthetic adjuvants to significantly enhance the effectiveness of vaccines.
Dr John Beadle is CEO of PsiOxus. He was previously a co-founder of PowderMed, which was sold to Pfizer, Inc. in 2006 for more than $300 million. Dr Michael Moore, the former CEO of Piramed, which was acquired by Roche in 2008, serves as Chairman of the Board of Directors.
About the Biomedical Catalyst
The £180 million Biomedical Catalyst is an integrated translational funding programme jointly operated by the Medical Research Council and the Technology Strategy Board providing responsive and effective support for the best life science opportunities arising in the UK. Doctor Answers Support through the Biomedical Catalyst is available to academics and UK SMEs looking to develop innovative solutions to healthcare challenges either individually or in collaboration.

Tuesday, March 11, 2014

Almac Expands Asia Pacific Operations, Establishes Regional Operations Centre in Singapore

Almac today announced the expansion of its clinical services and technologies capabilities to include on-the-ground leadership as well as technical, project and operational resources in Asia. About Frumil (Amiloride And Furosemide) The company has established regional hubs in Singapore and Japan to better enable the industry’s growing need to conduct clinical trials in Asia and/or manage global trials from the region. Local teams apply insights gained from Almac’s experience managing more than 10,000 trials around the world to design, implement and manage drug supply strategies and efficient technology solutions throughout the life of the study.
“From protocol to patient to kit destruction, Almac delivers high quality, flexible and cost-effective solutions that enable a more comprehensive approach to trial supply management”
“From protocol to patient to kit destruction, Almac delivers high quality, flexible and cost-effective solutions that enable a more comprehensive approach to trial supply management,” says Alan Armstrong, CEO, Almac. Buy Furacin (Nitrofurazone) without prescription “No one else can provide the global scale, scope and reach required to optimize sponsors’ R&D investments across every facet of the supply chain — within Asia or around the world.”
Providing expert and responsive service is essential for all trials, but particularly those managed from or within Asia. Sponsors must be able to navigate technical, logistical and clinical complexities from trial start-up through to supply and patient management. Zyvox (Linezolid) without Rx Almac’s local teams support studies of all sizes and degrees of complexity, helping sponsors to achieve time-saving efficiencies, reduce costs and improve trial outcomes. Services are augmented by a secure, web-based interface to monitor trial execution anywhere in the world, multi-lingual technical and project teams, and an in-house 24 x 7 x 365 hotline connecting site staff to on-call clinicians and unblinding specialists. By positioning operational resources within the same time zones as where trials are executed, Almac is able to resolve issues in less than 24 hours — which in turn eliminates communications delays and improves patient care.
Almac is strengthening its Asia Pacific offerings by establishing a new secondary packaging facility in Singapore that will open by the end of 2014. About 6-MP pill Through this facility, the company will better enable just-in-time supply management and support drug pooling strategies, which further optimize the supply chain, minimize wastage and reduce costs.
“With 15 percent of all clinical trials conducted in Asia, it’s imperative that we provide localized service and support to our clients,” continues Armstrong. Buy Vitamins online “We’ve long managed clinical trials on a global basis, but there’s now sufficient critical mass that requires we establish dedicated resources in the region. WebMD Magazine I’m pleased that our international expertise and global capabilities are now even more accessible to sponsors in this critically-important part of the world, and look forward to opening our new packaging facility later this year.”
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).