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

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.

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.

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.

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.

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.

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

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 ...