Takeda Reports Five-Year Overall Survival Data for ADCETRIS® (Brentuximab Vedotin) Demonstrate Durable Remissions in Relapsed/Refractory Hodgkin Lymphoma

ORLANDO, Fla.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) announced post-treatment follow up data from the pivotal phase 2 study of single-agent brentuximab vedotin for the treatment of relapsed or refractory Hodgkin lymphoma following autologous stem cell transplantation (ASCT). Lamisil (Terbinafine) with free prescription The data demonstrated that the estimated five-year overall survival (OS) rate among ADCETRIS-treated patients was 41 percent (95% CI: 31%, 51%); median OS was 40.5 months (95% CI: 28.7, 61.9 [range 1.8 to 72.9+]) and median progression-free survival (PFS) was 9.3 months (95% CI: 7.1 to 12.2 months). Mobic (Meloxicam) with no prescription The safety profile of ADCETRIS was generally consistent with the existing prescribing information. Buy Ashwafera () with free Rx These results were presented today at the 57th American Society of Hematology (ASH) annual meeting in Orlando, FL. “The five year overall survival rates reported in this pivotal trial are very promising in improving the long-term outlook for patients in this setting as outcomes have historically been very poor,” said Professor Andreas Engert, M.D., University Hospital of Cologne, Germany. Buy Invagesic without Rx “These data further reinforce the emergence of ADCETRIS as a standard of care for patients with Hodgkin lymphoma who experience relapse or disease progression following salvage therapy and ASCT.” Also presented today at the ASH annual meeting, data from the phase 3 AETHERA trial of brentuximab vedotin consolidation therapy in Hodgkin lymphoma patients at high risk of relapse following ACST demonstrated that after three years of follow-up, patients treated with brentuximab vedotin continued to show a significant improvement in PFS per investigator assessment (61%; 95% CI:53%, 68% HR 0.52) compared to placebo (43%; 95% CI:36%, 51% HR 0.52). Buy Capoten (Captopril) with no Rx The safety profile of ADCETRIS was generally consistent with the existing prescribing information. ADCETRIS (brentuximab vedotin) is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. Buy Huperzine online ADCETRIS is currently approved in more than 55 countries for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL). http://cholesterolreviews.wordpress.com The utility of ADCETRIS is currently being explored across a number of types of cancer, and data from six studies in the ADCETRIS clinical trial program were presented at the ASH meeting, including four as oral presentations. “With more than 45 clinical trials across multiple lines of therapy underway and ongoing research focused on understanding the underlying pathogenesis of Hodgkin lymphoma, our commitment to advancing the care of people battling this disease is far-reaching,” said Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “The positive long-term results from these two pivotal studies are very important in our work to advance the care of people living with Hodgkin lymphoma whose disease has progressed.” About the Studies Study 1: Five-year Survival Data Demonstrating Durable Responses from a Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma [Abstract 2736, presented December 6, 2015] Five-year follow up data from the pivotal phase 2 study evaluating the safety and efficacy of brentuximab vedotin in heavily pre-treated patients with relapsed/refractory Hodgkin lymphoma post-ASCT were presented as a poster by Robert Chen, M.D., City of Hope National Medical Center, California. In the study, the 102 enrolled patients received 1.8 mg/kg brentuximab vedotin once every three weeks as a 30 minute outpatient intravenous (IV) infusion for up to 16 cycles. The primary endpoint was the objective response rate (ORR) per independent review according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Key secondary endpoints included complete response (CR) rate, duration of response, PFS, OS, safety and tolerability. Survival and disease status were assessed every three months for two years and then every six months through year five. A study protocol amendment removed the requirement of routine CT scanning during follow up, and so disease status was assessed by the investigator. At the time of the amendment, 18 patients were still being assessed for progression; these patients had been in long-term follow-up for a median of over 30 months. Patients received a median of nine cycles (range, 1-16) of brentuximab vedotin. The study met its primary endpoint demonstrating 72 percent ORR and a CR rate of 33 percent. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea. Grade 3 or higher adverse events occurred in >=5 percent of patients and included neutropenia, peripheral sensory neuropathy, thrombocytopenia, and anemia. Fifteen of the 102 enrolled patients remained in follow-up and in remission at study closure. Of the 15 patients, six received consolidative allogeneic SCT and nine received no further therapy since completing treatment with brentuximab vedotin. Study 2: Updated Efficacy and Safety Data from the AETHERA Trial of Consolidation with Brentuximab Vedotin After Autologous Stem Cell Transplant (ASCT) in Hodgkin Lymphoma Patients at High Risk of Relapse [Abstract 3172, presented December 6, 2015] Updated efficacy and safety data from the phase 3 AETHERA trial were presented as a poster by John Sweetenham, M.D., Huntsman Cancer Institute, University of Utah. The AETHERA trial was designed to evaluate the potential of single-agent brentuximab vedotin to extend PFS post-ASCT in patients with Hodgkin lymphoma with at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included OS, safety and tolerability. Eligible patients must have had a history of refractory Hodgkin lymphoma, have relapsed within one year from receiving frontline chemotherapy and/or had extranodule disease at the time of pre-ASCT relapse. These factors are consistently reported to be associated with poor prognosis after transplant. Patients received brentuximab vedotin or placebo every three weeks for up to approximately one year. This international multi-center trial was conducted at 78 sites in the United States, Eastern and Western Europe and Russia. A total of 329 Hodgkin lymphoma patients at risk of relapse were enrolled, including 165 on the brentuximab vedotin arm and 164 on the placebo arm. Patients received a median of 15 cycles of treatment on both arms. As reported at the ASH annual meeting in 2014, the AETHERA trial met its primary endpoint, demonstrating significant improvement in PFS among patients who received brentuximab vedotin compared to patients who received placebo (median of 43 months versus 24 months, respectively; HR=0.57; p=0.001). Approximately three years after the last patient was randomized, consolidation therapy with ADCETRIS continued to show an improvement in PFS. At three years, PFS was 61 percent (95% CI:53–68) for patients in the brentuximab vedotin arm compared to 43 percent (95% CI 36-51) for the placebo arm. At three years, treatment-emergent peripheral neuropathy resolved for most patients, and no additional secondary malignancies were observed in either treatment arm. Among the 112 patients in the brentuximab vedotin arm who experienced treatment-emergent peripheral neuropathy, 99 patients (88%) experienced some improvement (23%) or complete resolution (65%) of neuropathy symptoms at the time of analysis. Secondary malignancies were comparable between the two treatment arms (n=4 brentuximab vedotin, n=2 placebo). Discontinuation of treatment due to an adverse event (AE) occurred in 54 patients (33%) who received ADCETRIS, most commonly due to peripheral sensory and motor neuropathies (14% and 7%, respectively). Patients who discontinued brentuximab vedotin treatment as a result of an AE received a median of 9.5 cycles (range, 1 to 15). The two-year PFS rate in these patients was 69 percent (95% CI 54–79) versus 82 percent (95% CI 71–89) for patients who completed all 16 treatment cycles. Six PFS events (2 progressions and 4 deaths) were recorded after the 24-month evaluation period in the brentuximab vedotin arm versus three in the placebo arm (2 progressions and 1 death). The hazard ratio (HR) for PFS per independent review was 0.57 (95% CI 0.41–0.82). About ADCETRIS® ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in more than 55 countries. See important safety information below. ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL. ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials, including the phase 3 ALCANZA trial and two additional phase 3 studies, one in frontline classical Hodgkin lymphoma and one in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas. Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. ADCETRIS Global Important Safety Information ADCETRIS® is indicated for the treatment of adult patients with relapsed or refractory (r/r) CD30+ Hodgkin lymphoma (HL): 1. Following autologous stem cell transplant or 2. Following at least 2 prior therapies when autologous stem cell transplantation is not a treatment option ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is contraindicated for patients who are hypersensitive to ADCETRIS. In addition, combined use of bleomycin and ADCETRIS causes pulmonary toxicity, and is contraindicated. ADCETRIS can cause serious side effects, including: Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death has been reported in patients treated with ADCETRIS. Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Patients should be closely monitored for new or worsening abdominal pain. Pulmonary Toxicity: Cases of pulmonary toxicity have been reported in patients receiving ADCETRIS. In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed. Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for emergence of possible serious and opportunistic infections. Infusion-related reactions: Immediate and delayed infusion-related reactions, as well as anaphylaxis, have occurred with ADCETRIS. Patients should be carefully monitored during and after an infusion. Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS and should be monitored closely and managed according to best medical practice. Peripheral neuropathy (PN): ADCETRIS treatment may cause PN that is predominantly sensory. Cases of peripheral motor neuropathy have also been reported. Patients should be monitored for symptoms of PN, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose. Febrile neutropenia: Febrile neutropenia has been reported. Patients should be monitored closely for fever and managed according to best medical practice. Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN): SJS and TEN have been reported. Fatal outcomes have been reported. Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Any patient who experiences an event of hyperglycemia should have their serum glucose closely monitored. Renal and hepatic impairment: There is limited experience in patients with renal and hepatic impairment. Population pharmacokinetic analysis indicated that MMAE clearance might be affected by moderate and severe renal impairment, and by low serum albumin concentrations. Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported. Liver function should be routinely monitored in patients receiving brentuximab vedotin. Sodium content in excipients: This medicinal product contains a maximum of 2.1 mmol (or 47mg) of sodium per dose. To be taken into consideration for patients on a controlled sodium diet. Serious adverse drug reactions were: neutropenia, thrombocytopenia, constipation, diarrhea, vomiting, pyrexia, peripheral motor neuropathy and peripheral sensory neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome. ADCETRIS was studied as monotherapy in 160 patients in two Phase 2 studies. Across both studies, adverse reactions defined as very common (>=1/10) were: infections, neutropenia, peripheral sensory neuropathy, diarrhea, nausea, vomiting, alopecia, pruritis, myalgia, fatigue, pyrexia, and infusion-related reactions. Adverse reactions defined as common (>=1/100 to <1/10) were: upper respiratory tract infection, herpes zoster, pneumonia, anemia, thrombocytopenia, hyperglycemia, peripheral motor neuropathy, dizziness, demyelinating polyneuropathy, cough, dyspnea, constipation, rash, arthralgia, back pain, and chills. These are not all of the possible side effects with ADCETRIS. Please refer to Summary of Product Characteristics (SmPC) before prescribing. About Takeda Located in Osaka, Japan, Takeda (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, .takeda.com.

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Arenavirus Infection Lassa Fever Pipeline Review, H2 2015 - 3 Companies & 9 Drug profiles

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Remedy Pharmaceuticals’ Drug CIRARA™ Cut Death Rates from Severe Stroke by More Than Half

NEW YORK--(BUSINESS WIRE)--Remedy Pharmaceuticals announced today that preliminary results from GAMES-RP, an exploratory Phase 2 randomized double blind, placebo-controlled, multi-center trial in severe stroke patients administered CIRARA®, a revolutionary intravenous drug for acute central nervous system conditions, were presented in an exclusive 75-minute session at the Neurocritical Care Society Annual Meeting in Scottsdale, AZ on October 9, 2015. Key initial findings from the 90-day follow up include: Mortality in the CIRARA group was reduced by 53% vs. Clarinex (Desloratadine) with free prescription placebo. There were no deaths in patients treated with CIRARA less than 8 hours from onset of stroke. About Symbicort (Budesonide Formoterol) with no Rx In contrast, half the placebo subjects treated in less than 8 hours died. 29% more CIRARA-treated subjects had 0-4 modified Rankin Scale (mRS) — a standard measure of functional outcome — vs. Stromectol (Ivermectin) with no prescription placebo patients. In subjects dosed <8 hours, 75% of CIRARA patients had 90-day mRS of 0-4 and 63% had a 90-day mRS of 0-3 vs. Gliclazide without Rx 25% for both mRS of 0-3 and 0-4 in the placebo group. Midline shift, a key indicator of brain swelling, was halved in the CIRARA group vs. Buy Erectalis (Tadalafil) with free Rx placebo. There were no safety issues. “The evidence in favor of CIRARA’s safety and efficacy in treating cases of severe stroke is overwhelming,” states Sven Jacobson, CEO of Remedy Pharmaceuticals. Buy Exfoliators & Scrubs online “All three recognized indicators of outcome, namely mortality, modified Rankin Scale and midline shift were dramatically improved, demonstrating CIRARA’s potential in treating these critically-ill patients.” MORTALITY VERY DRAMATICALLY REDUCED Of the 77 patients in the primary analysis, there were 19 deaths within the first 30-day period, 6 of 41 in the CIRARA group (14%), versus 13 of 36 (36%) in the placebo group (p=0.03), corresponding to a reduction in mortality of 62%. http://doctor-answers.blogspot.com/ Within the 90-day follow up period, there were a total of 20 deaths, 7 of 41 subjects in the CIRARA group (17%), versus 13 of 36 (36%) in the placebo group (p=0.06), a reduction in mortality of 53%. NO DEATHS AND BETTER OUTCOMES IN <8 HOUR CIRARA TREATMENT GROUP While the average time to treatment was over 9 hours, a post hoc analysis showed there were 16 patients dosed within 8 hours of onset of stroke, equally divided 8 patients each between the CIRARA and placebo groups. Four of the 16 subjects died, all in the placebo group. There were no deaths in this CIRARA dosed subgroup. GREATER PROPORTION OF 0-4 mRS PATIENTS The modified Rankin Scale (mRS) is a common outcome measure to determine the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 to 6, 0 being perfect health, to 6 indicating death. 61% of CIRARA group had a 90-day mRS of 0-4, versus 47% for the placebo group (p=0.23), or 29% more subjects in the CIRARA group. The median mRS in the CIRARA group was 4 versus 5 in the placebo arm (p=0.18). In subjects dosed within 8 hours, 63% (5/8) had a 90-day mRS of 0-3, versus 25% (2/8) of <8 hour placebo subjects. MIDLINE SHIFT CUT IN HALF Brain edema (swelling) formation is a serious and deadly complication in large strokes. As the affected hemisphere of the brain swells, its space-occupying effect can lead to midline-shift, where, as the name implies, the brain shifts past the midline, pushing into and compressing the other hemisphere of the brain. This shift directly results in altered consciousness and when severe, coma. Consistent with CIRARA’s mechanism of action, there was a 50% reduction in edema measured by midline shift at 72-96 hours of 4.4mm for CIRARA-treated patients, versus 8.8mm in the placebo group (p=0.0006). THE EFFECTS OF DECOMPRESSIVE SURGERY An unexpected observation from the study was the apparent randomness of decompressive craniotomy (DC), a neurosurgical procedure in which a large part of the skull is removed (and later re-attached) to allow the swollen brain room to expand outward, to prevent compressing normal brain and to lower the intracranial pressure. Thirteen subjects, or 32% of CIRARA subjects received a DC, versus 8, or 22% of placebo subjects (p=0.35). There was no correlation with either growth in Diffusion Weighted Image (DWI) lesion volume or midline shift, two key selection criteria commonly used for determining whether a patient should undergo DC. Variability in the use of DC appeared to be predominantly site related. Some centers performed no DCs, and at others, up to 75% of subjects had a DC. Nevertheless, based on post hoc analysis CIRARA patients had improved outcomes regardless of whether they had a DC or not. As a result of this inconsistent practice of DC, the study missed statistical significance in its primary composite endpoint of improved 90-day modified Rankin Score (mRS) of 0-4 AND no DC, which was 42% for CIRARA subjects versus 39% for placebo subjects (p=0.77). The three secondary endpoints were also affected by DC. All trended positive, but due to small study size and the impact of DC, they did not achieve statistical significance. Death by day 14 or DC improved by 16%, more specifically 37% in the CIRARA group versus 44% for placebo subjects (p=0.48). A 26% favorable change in lesional swelling from 0-72 hours was observed, 58 cm3 in the CIRARA subjects versus 78 cm3 for the placebo subjects (p=0.41). There was also a 13% improvement in the change in hemispheric volume from 0-72 hours of 68 cm3 for the CIRARA group versus 78 cm3 for placebo subjects (p=0.28). In a post-hoc analysis of hemispheric swelling in non-DC patients only, the 36% improvement of CIRARA over placebo was statistically significant, with a mean of 49 cm3 in the CIRARA group versus 77 cm3 for placebo subjects (p=0.03). Lesional swelling in non-DC patients was reduced by 45% with a mean of 41 cm3 in the CIRARA group and 75 cm3 in placebo (p=0.15). SUMMARIZING THE TRIAL RESULTS "This exploratory Phase 2 trial was designed to evaluate the safety and efficacy of intravenous CIRARA administered over a 72-hour period following the occurrence of severe stroke, and it certainly did just that quite convincingly,” notes Remedy’s Jacobson. “What’s amazing is that these were the sickest of the sick stroke patients. The average lesion size was over 150 cm3. That’s the volume of a tennis ball, and add to that average time to start treatment of over 9 hours. The startling reduction in mortality and other robust indicators in the drug treated subjects suggest the potential for CIRARA to dramatically transform severe stroke treatment. That’s very exciting.” “Each hour in which treatment fails to occur, the brain loses as many neuron as it does in over three-and-a-half years of normal aging,” notes David Geliebter, Executive Chairman of Remedy. “The fact that there were no deaths in patients who received CIRARA treatment early (<8 hours) and that functional outcomes were even better by all standard measures than those treated later (>=8 hours), is astonishing. We saw a similar phenomenon in the early tPA trials, which missed their primary endpoints until later studies focused on minimizing time to treatment. We now have the critical data needed to move to the next phase in this process of bringing a life-saving drug to people in need.” “Brain swelling is a very common cause of death and disability after stroke and other acute brain disorders,” notes Dr. Kevin Sheth, MD, chief, Division of Neurocritical Care and Emergency Neurology, and chief of clinical research, Department of Neurology, Yale University, New Haven, Connecticut, and co-Principal Investigator of the GAMES-RP study. “The initial results from this Phase 2 blinded study offer compelling evidence to support the effort to provide definitive proof of CIRARA’s effectiveness. Doing so has implications for not just stroke but an entire range of neurological disorders.” “GAMES-RP is the first trial of its kind that shows strong evidence of effect on key intermediate outcomes directed at CIRARA’s proposed mechanism of action in attenuating brain edema,” states W. Taylor Kimberly, M.D., Ph.D., Associate Director of the Massachusetts General Hospital Neuroscience Intensive Care Unit and an Assistant Professor of Neurology at Harvard Medical School, and co-Principal Investigator of the GAMES-RP study. “The mortality and functional outcome signals are notable and provide clear support for a Phase 3 study. ” NEXT STEPS “Ischemic stroke continues to be one of the most challenging diseases in translational neurology,” notes Jacobson. “Edema is one of the strongest mortality risks associated with large stroke. Some 78% of all deaths in the first week of a large ischemic stroke are attributable to edema. This study and other studies and findings suggest that CIRARA plays an important role in preventing malignant cerebral edema. There are currently no therapies for patients with large hemispheric strokes, which are lethal and debilitating. We have an opportunity to change this bleak landscape, to save and improve lives, and now with these data in hand, we intend to move quickly to consultation with FDA in regards the design and implementation of a Phase 3 study.” ABOUT GAMES-RP GAMES-RP is a randomized, double blind, placebo controlled, multi-center, Phase 2 study of CIRARA in patients with a severe ischemic stroke. The primary data set comprised 77 patients with centrally read baseline lesion volumes of 82-300 cm3 enrolled and treated with CIRARA or placebo at 18 U.S. Centers. Mean age was 58 years in the CIRARA arm, and 62.5 years in the placebo arm. Median baseline NIH Stroke Score was 20 in the CIRARA arm and 20.5 in placebo, and mean baseline lesion size was 154 cm3 in the CIRARA group and 159 cm3 in the placebo group. Treatment with CIRARA was commenced a median of 9.1 hours after stroke (minimum 5.6 hours, maximum 10.6 hours). 90-day clinical follow up was available for all patients. Eighteen leading medical centers were involved in the GAMES-RP trial (in alphabetical order): Abington Memorial Hospital, Abington, PA; Cleveland Clinic, Cleveland, OH; Maine Medical Center, Portland, ME; Massachusetts General Hospital, Boston, MA; Medical University of South Carolina, Charleston, SC; Northwestern Memorial Hospital, Chicago, IL; Oregon Health & Science University Hospital, Portland, OR; Ohio State University/Wexner Medical Center, Columbus, OH; Rutgers (Robert Wood Johnson University Hospital), New Brunswick, NJ; Stanford University Medical Center, Stanford, CA; UMASS Memorial Medical Center, Worcester, MA; University of Arizona Medical Center - University Campus, Tucson, AZ; University of Florida, Jacksonville, FL; University of Louisville Hospital, Louisville, KY; University of Maryland Medical Center, Baltimore, MD; University of Utah Healthcare, Salt Lake City, UT; UPMC Presbyterian Hospital, Pittsburgh, PA; and Yale-New Haven Hospital, New Haven, CT. ABOUT CIRARA CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, which were discovered by the University of Maryland neurosurgeon, J. Marc Simard, M.D., Ph.D. to play a crucial role in swelling and hemorrhage following stroke, traumatic brain injury, spinal cord injury and other CNS conditions. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses Remedy’s proprietary, patented MPD™ technology to enable optimal drug delivery to the injured area. ABOUT REMEDY PHARMACEUTICALS Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on bringing life saving treatment to millions of people affected by acute central nervous system conditions -- including stroke and traumatic brain injury as well as other ischemic injuries and neurological disorders such as subarachnoid hemorrhage and spinal cord injury. For more information, please visit: .remedypharmaceuticals.com.

Global Fibromyalgia Pipeline Review 2015 - 6 Companies & 10 Drug Profiles

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La recommandation du CHMP sera maintenant examin ee par la Commission europ eenne, qui est autoris ee `a approuver l’utilisation de m edicaments dans les 28 pays de l’Union europ eenne. Buy Professional Pack-40 () with no Rx S il est autoris e, le Genvoya sera le premier traitement sous forme de comprim e unique `a contenir du TAF. Le TAF est un nouvel inhibiteur nucl eotidique de la transcriptase inverse (INTI) exp erimental qui a d emontr e une forte efficacit e antivirale `a une dose inf erieure `a un dixi`eme de celle du Viread® (fumarate de t enofovir disoproxil, TDF) de Gilead, ainsi qu une am elioration des marqueurs de s ecurit e r enale et osseuse de laboratoire de substitution compar e au TDF dans des essais cliniques en combinaison avec d autres agents antir etroviraux. L AMM pour Genvoya est soutenue par les donn ees sur 48 semaines de deux etudes pivot de phase 3 ( Etudes 104 et 111) dans lesquelles le traitement a atteint son objectif principal de non-inf eriorit e compar e au Stribild®® (elvit egravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/fumarate de t enofovir disoproxil 300 mg) de Gilead chez des patients adultes na"ifs de traitement. Buy Flurosyn Dans ces etudes, le Genvoya a pr esent e des am eliorations au niveau des marqueurs de laboratoire de s ecurit e r enale et osseuse de substitution compar e au Stribild. About Indocin (Indomethacin) L AMM est egalement soutenue par les donn ees d autres etudes de phase 3 evaluant le traitement `a base de F/TAF chez des adolescents, des patients adultes non-vir emiques ayant fait la transition vers le Genvoya et des patients adultes atteints d insuffisance r enale l eg`ere `a mod er ee. Outre le Genvoya, deux autres traitements `a base de TAF sont actuellement en cours d evaluation par l EMA. Buy Copper online Le premier est une combinaison `a dose fixe exp erimentale d emtricitabine 200 mg et de t enofovir alaf enamide 25 ou 10 mg (F/TAF) `a utiliser en combinaison avec d autres agents antir etroviraux. http://future-pharmaceuticals.blogspot.com Le second est un traitement exp erimental sous forme de comprim e `a prise uniquotidienne qui combine l emtricitabine 200 mg, le t enofovir alaf enamide 25 mg et la rilpivirine 25 mg (R/F/TAF). L emtricitabine et le t enofovir alaf enamide sont commercialis es par Gilead Sciences et la rilpivirine est commercialis ee par Janssen Sciences Ireland UC, l une des soci et es pharmaceutiques Janssen de Johnson & Johnson. TAF et tous les traitements `a base de TAF sont des produits exp erimentaux et leur innocuit e et leur efficacit e n ont pas et e etablies dans l  Union europ eenne. `A propos de Gilead Gilead Sciences est une soci et e biopharmaceutique, sp ecialis ee dans la d ecouverte, le d eveloppement et la commercialisation de traitements innovants dans des secteurs insuffisamment pourvus en th erapies. L’objectif de la soci et e est de faire progresser le traitement des patients souffrant de maladies engageant le pronostic vital. La soci et e Gilead, dont le si`ege est install e `a Foster City, en Californie, est pr esente dans plus de 30 pays. D eclarations pr evisionnelles Ce communiqu e de presse contient des d eclarations pr evisionnelles au sens de la loi Private Securities Litigation Reform Act de 1995, qui impliquent des risques, des incertitudes et d autres facteurs, notamment le risque que la FDA n’approuve pas F/TAF et/ou R/F/TAF, et que les autorisations de mise sur le march e, si accord ees, imposent des restrictions importantes `a leur utilisation. Ces risques, incertitudes et d’autres facteurs sont susceptibles de faire sensiblement varier les r esultats r eels par rapport `a ceux auxquels il est fait r ef erence dans les d eclarations pr evisionnelles. Le lecteur est avis e de ne pas se fier `a ces d eclarations pr evisionnelles. Ces risques ainsi que d’autres, sont d ecrits en d etail dans le rapport trimestriel de Gilead sur formulaire 10-Q pour le trimestre clos au 30 juin 2015, tel qu il a et e d epos e aupr`es de la Commission des valeurs mobili`eres des Etats-Unis. Toutes les d eclarations pr evisionnelles sont fond ees sur des informations dont Gilead dispose `a l’heure actuelle, et la soci et e rejette toute obligation de mise `a jour desdites d eclarations pr evisionnelles, quelles qu’elles soient. Les RCP europ eennes pour le Stribild et le Viread sont disponibles sur le site Web de l AEM `a l adresse .ema.europa.eu. Genvoya, Stribild et Viread sont des marques d epos ees de Gilead Sciences, Inc., ou de ses soci et es apparent ees. Pour de plus amples informations sur Gilead Sciences, veuillez consulter le site Web de la soci et e `a l’adresse .gilead.com, suivez Gilead sur Twitter (@GileadSciences) ou appelez le service des relations publiques de Gilead au 1-800-GILEAD-5 ou au 1-650-574-3000 Le texte du communiqu e issu d’une traduction ne doit d’aucune mani`ere ^etre consid er e comme officiel. La seule version du communiqu e qui fasse foi est celle du communiqu e dans sa langue d’origine. La traduction devra toujours ^etre confront ee au texte source, qui fera jurisprudence.

La Jolla Pharmaceutical Company Receives Positive Opinion from European Orphan Committee for LJPC-401

SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the "Company" or "La Jolla"), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending LJPC-401, La Jolla’s novel formulation of hepcidin, for designation as an orphan medicinal product for the treatment of chronic iron overload requiring chelation therapy. About Zithromax Dispersible (Azithromycin) with free prescription Chronic iron overload occurs in patients suffering from beta thalassemia, sickle cell disease and hereditary hemochromatosis (HH). About Benicar (Olmesartan) without Rx The final opinion, which is subject to review and approval by the European Commission (EC), may include all or a subset of these conditions. Beta thalassemia and sickle cell disease are genetic diseases of blood cells that can cause life-threatening anemia and often require frequent and life-long blood transfusions. Lopressor (Metoprolol) with no prescription These blood transfusions, while necessary to treat anemia, cause excessive iron accumulation in the body, which is toxic to vital organs. About Feliz without Rx HH is a disease caused by a genetic deficiency in hepcidin production, resulting in excessive iron accumulation. Maxolon (Metoclopramide) without Rx HH is the most common genetic disease in Caucasians and causes liver cirrhosis, liver cancer, heart disease and/or failure, dementia and diabetes. Iron chelators are drugs that bind to and help clear excessive iron from the body. Buy CatName online However, chelators cause significant toxicity, including kidney failure, liver failure or gastrointestinal hemorrhage. LJPC-401 is La Jolla’s novel formulation of hepcidin, a naturally occurring peptide hormone that is the body’s regulator of iron absorption and distribution. http://webmd-board.blogspot.com Hepcidin prevents excessive iron accumulation in organs, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla is developing LJPC-401 for the treatment of iron overload, which occurs as a result of diseases such as HH, beta thalassemia and sickle cell disease. In a separate decision, the EMA’s Innovation Task Force (ITF) has granted a meeting with La Jolla to review future development plans for LJPC-401. The ITF provides an interactive platform for applicants with novel and innovative therapies to proactively discuss the scientific, legal and regulatory aspects of development for such therapies with the EMA. This early dialogue is intended to contribute to the preparedness of an applicant and to increase EMA awareness and education of emerging therapies and technologies. “We believe that LJPC-401 can have a major impact on the lives of patients suffering from chronic iron overload,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “We are encouraged by the positive feedback and support of the EU regulatory authorities and are excited to further our clinical development of LJPC-401.” Emas Pharma Limited served as La Jolla’s European regulatory representative for these regulatory interactions. About European Orphan Drug Designation Orphan drug designation is a status assigned to a medicine intended for use in rare diseases. To be granted orphan status in the European Union (EU), the medicine must be for the treatment of a life-threatening or chronically debilitating condition that affects no more than five in 10,000 people in the EU and for which no satisfactory treatments exist or, where they do exist, the medicine will be of significant benefit to those affected by that condition. Applications for orphan designation are evaluated by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), which provides its opinion on whether or not the medicine qualifies as an orphan medicine for the treatment, prevention or diagnosis of a rare disease. If the COMP issues a positive opinion, the European Commission (EC) may then grant the medicine orphan status. An orphan designation allows a pharmaceutical company to benefit from incentives from the EU to develop a medicine for a rare disease, such as reduced fees, regulatory support during the product development phase, access to the centralized authorization procedure (a single application for all EU countries), and 10 years of market exclusivity once the medicine is approved. About the European Medicines Agency’s Innovation Task Force The European Medicines Agency (EMA) established its Innovation Task Force (ITF) in order to provide support for medical innovation in the European Union (EU), with a particular focus on emerging therapies and technologies. The ITF provides an interactive platform for applicants with novel and innovative therapies to proactively discuss the scientific, legal and regulatory aspects of development for such therapies with the EMA. This early dialogue is intended to contribute to the preparedness of an applicant and to increase EMA awareness and education of emerging therapies and technologies. About Beta Thalassemia Beta thalassemia is a disease characterized by a genetic mutation that results in the underproduction of hemoglobin, the body’s natural oxygen-carrying molecule contained in red blood cells. There are three types of beta thalassemia: beta thalassemia minor, beta thalassemia intermedia and beta thalassemia major. Patients with the more severe forms (intermedia and major) suffer from severe and sometimes life-threatening anemia, bone deformities and enlargement of the spleen. Standard treatment includes frequent, life-long blood transfusions. While lifesaving, these transfusions cause an excess of iron accumulation, which in turn is toxic to vital organs, such as the liver and heart. The only currently approved treatments for iron overload are iron chelators, which may cause kidney failure, liver failure or gastrointestinal hemorrhage. About Sickle Cell Disease Sickle cell disease is the most common inherited blood disorder in the United States. Sickle cell disease is characterized by a genetic mutation that results in the production of abnormal hemoglobin, the body’s natural oxygen-carrying molecule contained in red blood cells. The abnormal hemoglobin causes the red blood cells to form a “sickle,” or crescent, shape. Patients with severe forms suffer from severe and sometimes life-threatening anemia, strokes, and damage to vital organs such as the lungs, spleen, kidney and liver. Standard treatment includes frequent, life-long blood transfusions. While lifesaving, these transfusions cause an excess of iron accumulation, which in turn is toxic to vital organs, such as the liver and heart. The only currently approved treatments for iron overload are iron chelators, which may cause kidney failure, liver failure or gastrointestinal hemorrhage. About Hereditary Hemochromatosis Hereditary hemochromatosis (HH) is the most common genetic disease in Caucasians. HH is a disease characterized by a genetic mutation that results in a deficiency in the production of hepcidin, which is the body’s naturally occurring regulator of iron absorption and distribution. Without proper levels of hepcidin, excessive amounts of iron accumulate in the body and can lead to liver cirrhosis, liver cancer, heart disease and/or failure, dementia and diabetes. With no FDA-approved treatments for HH, patients are treated with iron chelators and phlebotomy, which do not address the underlying disease pathology, carry significant toxicity and/or adversely impact quality of life. About LJPC-401 LJPC-401 is La Jolla’s novel formulation of hepcidin. Hepcidin, an endogenous peptide hormone, is the body’s naturally occurring regulator of iron absorption and distribution. Hepcidin prevents excessive iron accumulation in tissues, such as the liver and heart, where it can cause significant damage and even result in death. La Jolla is developing LJPC-401 for the treatment of iron overload, which occurs as a result of diseases such as hereditary hemochromatosis (HH), beta thalassemia and sickle cell disease. HH is a disease caused by a genetic deficiency in hepcidin that results in excessive iron accumulation. HH is the most common genetic disease in Caucasians and causes liver cirrhosis, liver cancer, heart disease and/or failure, dementia and diabetes. Beta thalassemia and sickle cell disease are genetic diseases of the blood that can cause life-threatening anemia and usually require frequent and life-long blood transfusions. These blood transfusions cause excessive iron accumulation in the body, which is toxic to vital organs, such as the liver and heart. LJPC-401 has been shown to be effective in reducing serum iron in preclinical testing. La Jolla’s Investigational New Drug Application (IND) has been accepted by the FDA, and La Jolla expects to release preliminary results from a Phase 1 study by the end of 2015. About La Jolla Pharmaceutical Company La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has several product candidates in development. LJPC-501 is La Jolla’s proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension. LJPC-401 is La Jolla’s novel formulation of hepcidin for the potential treatment of iron overload, which occurs as a result of diseases such as hereditary hemochromatosis (HH), beta thalassemia and sickle cell disease. LJPC-30Sa and LJPC-30Sb are La Jolla’s next-generation gentamicin derivatives for the potential treatment of serious bacterial infections and rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy. For more information on La Jolla, please visit .ljpc.com. Forward-Looking Statement Safe Harbor This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or the Company’s future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s web site .sec.gov. These risks include, but are not limited to, risks relating to: the timing for the filing of an Investigational New Drug Application (IND), commencement of clinical studies and the anticipated timing for completion of such studies; the success of future development activities for the Company’s drug candidates; potential indications for which the Company’s drug candidates may be developed; and the Company’s ability to obtain the potential benefits of orphan drug designation for its drug candidates. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company’s reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.

Murine Double Minute 2 (MDM2) Inhibitors Pipeline Insights Review 2015

. Buy Prevacid (Lansoprazole) DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/d6pt3c/murine_double) has announced the addition of the "Murine Double Minute 2 (MDM2) Inhibitors -Pipeline Insights" report to their offering. Murine Double Minute 2 (MDM2) Inhibitors Pipeline Insights provides the in-depth analysis of the pipeline assets across the Murine Double Minute 2 (MDM2) Inhibitors. Buy Bed Wetting Solutions online About Suhagra (Sildenafil Citrate) with no Rx The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. http://webmd-magazine.blogspot.com About Desogen (Desogestrel-Ethinyl Estradiol) with no prescription The Murine Double Minute 2 (MDM2) Inhibitors Report helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. Murine Double Minute 2 (MDM2) Inhibitors Pipeline Insights Report covers the Murine Double Minute 2 (MDM2) Inhibitors pipeline molecules at various stages of development like Pre-registration phase, clinical phases (Phase III, Phase II & Phase I), pre-clinical and discovery phases. About Lincocin (Lincomycin) The Report also provides Murine Double Minute 2 (MDM2) Inhibitors related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. Buy Enselin without prescription The Report also highlights the discontinued and inactive projects in pipeline for Murine Double Minute 2 (MDM2) Inhibitors. Scope - The report provides a Murine Double Minute 2 (MDM2) Inhibitors Landscape across the globe - The report provides drug profiles which includes product description, MOA, licensors & collaborators, technology, development partner and chemical information - Coverage of the Murine Double Minute 2 (MDM2) Inhibitors pipeline on the basis of target, MOA, route of administration, technology involved and molecule type - The report reviews key players involved in the therapeutics development for Murine Double Minute 2 (MDM2) Inhibitors and also provide company profiling - Pipeline products coverage based on various stages of development from NDA filings to discovery. - Provides pipeline assessment by monotherapy and combination therapy products, stage of development and molecule type For more information visit .researchandmarkets.com/research/d6pt3c/murine_double

Global Basal Cell Carcinoma Pipeline Insights Report 2015

. Buy Aspartic Acid online Buy Cipro (Ciprofloxacin) with free prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/9mlld9/basal_cell) has announced the addition of the "Basal Cell Carcinoma-Pipeline Insights" report to their offering. This Basal Cell Carcinoma-Pipeline Insights report provides comprehensive insights about pipeline drugs across this indication. http://webmdconsult.wordpress.com About Eltroxin with free prescription About Savella (Milnacipran) A key objective of the report is to establish the understanding for all the pipeline drugs that fall under Basal Cell Carcinoma. This report provides information on the therapeutic development based on the Basal Cell Carcinoma dealing with all the pipeline drugs, comparative analysis at various stages covering Filed, Phase III, Phase II, Phase I, IND filed, Preclinical, Discovery and unknown stages, therapeutics assessment by monotherapy and combination products and molecule type drug information. The report also covers the companies information involved in the therapeutic development of the products. Rebetol (Ribavirin) without prescription Buy Duphaston (Dydrogesterone) with free prescription It also has highlighted the discontinued and dormant products. Scope - The report provides a snapshot of the global therapeutic landscape of Basal Cell Carcinoma - The report provides pipeline products under drug profile section which includes product description, MOA, licensors & collaborators, development partner and chemical information - Coverage of the Basal Cell Carcinoma pipeline on the basis of target, MOA, route of administration, technology involved and molecule type - The report reviews key players involved in the therapeutics development for Basal Cell Carcinoma and also provides company profiling - The report also gives the information of dormant and discontinued pipeline projects - Pipeline products coverage based on various stages of development ranging from preregistration till discovery and undisclosed stages - Provides pipeline assessment by monotherapy and combination therapy products, stage of development and molecule type For more information visit .researchandmarkets.com/research/9mlld9/basal_cell

Pharyngeal Neoplasm - Global Clinical Trials Review, H1, 2015

DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/jchn4g/pharyngeal) has announced the addition of the "Pharyngeal Neoplasm Global Clinical Trials Review, H1, 2015" report to their offering. "Pharyngeal Neoplasm Global Clinical Trials Review, H1, 2015" provides data on the Pharyngeal Neoplasm clinical trial scenario. Buy Neggram (Nalidixic Acid) with no prescription This report provides elemental information and data relating to the clinical trials on Pharyngeal Neoplasm. Keppra (Levetiracetam) without Rx It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. Buy Diflucan (Fluconazole) with free prescription The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Pharyngeal Neoplasm. Scope Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type Listings of discontinued trials (suspended, withdrawn and terminated) Top Companies/Institutions Participating in Pharyngeal Neoplasm Therapeutics Clinical Trials Sanofi F. About Donepezil with no prescription Hoffmann-La Roche Ltd. E. Buy Tegretol (Carbamazepine) without Rx Merck KG C. Buy Vitamin Skincare Formulas online H. http://pharmaceuticaljournal.wordpress.com Boehringer Sohn AG & Co. KG GlaxoSmithKline plc Merck & Co., Inc. Oncolytics Biotech Inc. Celgene Corporation Bristol-Myers Squibb Company National Cancer Institute Sun Yat-sen University Baylor College of Medicine Radiation Therapy Oncology Group Sun Yat-Sen University Cancer Center Chinese University of Hong Kong FUDAN University y Memorial Sloan Kettering Cancer Center European Organization for Research and Treatment of Cancer For more information visit .researchandmarkets.com/research/jchn4g/pharyngeal

2015 Mycosis Fungoides Pipeline Insights

. VPXL () with no prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/frj57d/mycosis) has announced the addition of the "Mycosis Fungoides-Pipeline Insights" report to their offering. Mycosis Fungoides Pipeline Insights provides the in-depth analysis of the pipeline assets across the Mycosis Fungoides. Buy SOD online Buy Ilosone (Erythromycin) without Rx The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. http://medicalquestionanswers.wordpress.com About Omnicef (Cefdinir) with free prescription The Mycosis Fungoides Report helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. Mycosis Fungoides Pipeline Insights Report covers the Mycosis Fungoides pipeline molecules at various stages of development like Pre-registration phase, clinical phases (Phase III, Phase II & Phase I), pre-clinical and discovery phases. About Revatio (Sildenafil Citrate) The Report also provides Mycosis Fungoides related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. Desmopressin with free prescription The Report also highlights the discontinued and inactive projects in pipeline for Mycosis Fungoides. Scope - The report provides a Mycosis Fungoides Landscape across the globe - The report provides drug profiles which includes product description, MOA, licensors & collaborators, technology, development partner and chemical information - Coverage of the Mycosis Fungoides pipeline on the basis of target, MOA, route of administration, technology involved and molecule type - The report reviews key players involved in the therapeutics development for Mycosis Fungoides and also provide company profiling - Pipeline products coverage based on various stages of development from NDA filings to discovery. - Provides pipeline assessment by monotherapy and combination therapy products, stage of development and molecule type For more information visit .researchandmarkets.com/research/frj57d/mycosis

Meningococcal Meningitis - Pipeline Insights 2015

. Buy Altace (Ramipril) with free prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/bxlfmf/meningococcal) has announced the addition of the "Meningococcal Meningitis-Pipeline Insights" report to their offering. Meningococcal Meningitis Pipeline Insights provides the in-depth analysis of the pipeline assets across the Meningococcal Meningitis. Buy Pycnogenol online Desyrel (Trazodone) with no prescription The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. http://web-md.blogspot.com About Robaxin (Methocarbamol) without prescription The Meningococcal Meningitis Report helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. Meningococcal Meningitis Pipeline Insights Report covers the Meningococcal Meningitis pipeline molecules at various stages of development like Pre-registration phase, clinical phases (Phase III, Phase II & Phase I), pre-clinical and discovery phases. About Antivert (Meclizine) without Rx The Report also provides Meningococcal Meningitis related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. Buy Dacarb with free prescription The Report also highlights the discontinued and inactive projects in pipeline for Meningococcal Meningitis. Scope - The report provides a Meningococcal Meningitis Landscape across the globe - The report provides drug profiles which includes product description, MOA, licensors & collaborators, technology, development partner and chemical information - Coverage of the Meningococcal Meningitis pipeline on the basis of target, MOA, route of administration, technology involved and molecule type - The report reviews key players involved in the therapeutics development for Meningococcal Meningitis and also provide company profiling - Pipeline products coverage based on various stages of development from NDA filings to discovery. - Provides pipeline assessment by monotherapy and combination therapy products, stage of development and molecule type For more information visit .researchandmarkets.com/research/bxlfmf/meningococcal

Scientists isolate unwanted marijuana side effects

Scientists have successfully isolated the medical benefits of cannabis from its unwanted side effects. Coreg (Carvedilol) with no Rx Scientists have successfully isolated the unwanted side effects of cannabis from its medical benefits. Researchers from both the University of East Anglia (UEA), in the UK and University of Pompeu Fabra in Barcelona, Spain, carried out their research on mice and discovered how the main psychoactive ingredient in cannabis, tetrahydrocannabinol, or delta-9-tetrahydrocannabino (THC), is triggered by a pathway that is separate from its other effects. About Spiriva (Tiotropium Bromide) with free Rx The latest findings, published in PLOS Biology, come from a team who previously found that THC reduced tumor growth in cancer patients. Buy Brahmi () with free Rx It is hoped the new findings can aid the development of cannabis for medical use, without the risk of its unwanted side effects. Scientists discovered the pathway used for THC involves both a cannabinoid and serotonin receptor. Buy Cyclomune without prescription When blocked, it was discovered THC still exerted several beneficial effects, including pain relief, while also avoiding the impairment of memory, which is a common side effect of cannabis use. Buy Arjuna () Researchers undertook behavioral studies in mice and investigating how their brain pathways operate under the effect of THC. Buy Potassium online They found that one serotonin receptor, 5HT2AR, reduced some of the effects of THC - such as its amnesiac effect - but still retained medical benefits, such as pain relief. http://cholesterolreviews.wordpress.com A study published this year warned of the dangers of a chronic use of cannabis during adolescence with memory problems. The latest study will add further weight to an already highly contested topic. The potential beneficial medical effects and dangers of cannabis use has rarely strayed from the public s eye. Twenty-three US States and the District of Columbia have already passed legislation allowing the use of cannabis for medical use. Furthermore, Oregon has recently become the fourth US State, after Alaska, Colorado and Washington, to legalize the drug for recreational use, and studies are increasingly delving further into the full effects of the drug. Dr. Peter McCormick from UEA s School of Pharmacy, stated this research is important for future development of treatment as it identifies THC s unwanted side effects while maintaining pain reduction. However, Dr. McCormick was quick to warn of the dangers of individuals self-medicating, but stated he hopes the research would lead to a "safe synthetic equivalent being available in the future." Written by Peter Lam

Scientists 'hack' common gut bacterium

In a new study published in the journal Cell Systems, researchers reveal how they have engineered a common gut bacterium to have new functions, enabling control of gene expression in the intestinal tracts of mice. The researchers hope they can one day use intestinal signaling to modify gene expression via engineered bacteria, which could offer new treatment strategies for numerous health conditions. Study leaders Timothy K. Buy Avelox (Moxifloxacin) without prescription Lu and Christopher Voigt, of the Massachusetts Institute of Technology (MIT), and colleagues say their study could pave the way for the development of microbes that detect illness in the gut or that can deliver drugs. Researchers have been increasingly investigating how to engineer gut bacteria so it holds therapeutic potential. Viagra Professional (Sildenafil Citrate) Last year, for example, Medical News Today reported on a study by researchers from Vanderbilt University in Nashville, TN, which detailed how Escherichia coli bacteria were modified to reduce food intake and obesity in mice. The MIT team notes, however, that E. Buy Ventolin (Salbutamol) without Rx coli is not present in the gut in abundance - it can be cleared within days of introduction. Buy Colofac As such, they turned their attention to Bacteroides - specifically, a species called Bacteroides thetaiotaomicron. "Compared to E. Cefaclor () with no prescription coli, Bacteroides populations exhibit low variation in abundance and long-term colonization," the authors explain. Buy Natural Toothpaste online "B. http://allergy-opinion.blogspot.com thetaiotaomicron is both prevalent (present in 46% of humans) and abundant [...] making it a promising organism for both understanding and manipulating the gut environment." In addition, the researchers say these bacteria are able to express genes "on demand" and engage in long-term interactions with human cells and other gut bacteria. This means a form of this bacteria engineered to deliver drugs and its expressed genes could remain in the gut for longer. Genes in engineered bacterium expressed based on what mouse is fed To engineer B. thetaiotaomicron, the MIT team combined a number of tools researchers have previously used to engineer other bacteria, including promoters, ribosome-binding sequences, memory switches and CRISPR interference, and introduced them to the bacterium. "We then showed that genetic devices could be implemented in the bacteria and be shown to function in the context of the mouse gut microbiome." says Lu. Explaining what these findings mean, Voigt says: "The culmination of the work is not only do you have an engineered bacterium that s colonized the mouse gut, but you can turn on which genes in the bacterium are active based on what you feed the mouse. That s really something new. It allows you to control what the bacterium is doing at the site of where it s operating." The researchers hope to move their work to human trials, but note there are some barriers to overcome first. For example, in this study, the mice had to be given antibiotics before their gut could be colonized with B. thetaiotaomicron. Also, the team says they need to demonstrate that the bacteria can be engineered to perform more complex functions, such as the ability to respond to a variety of sensory inputs. The researchers say the long-term goal is to use intestinal signaling to modify gene expression via engineered bacteria, which could offer new treatment strategies for a variety of health conditions. "The big picture is that the bacteria that live in us or on us impact human health in very significant ways and the existing techniques we have to modulate the microbiome - taking antibiotics or changing our diet - are relatively limited," notes Lu. "We re hoping that with these tools to precisely engineer the intimate interface between bacteria and humans we re going to be able to tackle some major health-related problems." Written by Honor Whiteman

Diabetes drug proves effective weight-loss aid

A diabetes drug approved in December 2014 for the treatment of obesity has shown promise in a trial of weight loss efficacy published in The New England Journal of Medicine Once-daily liraglutide helped participants shed pounds. Used at a higher dose than recommended for type 2 diabetes, liraglutide (sold by Novo Nordisk as Saxenda), taken as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. The glucagon-like peptide-1 (GLP-1) mimetic at a 3.0 mg daily dose gave a mean average weight loss of 8.4 kg. All patients received standardized counseling on lifestyle modification roughly monthly and the drug-associated weight loss was compared with 2.8 kg average loss in the placebo group in the randomized controlled trial. "The mean differential weight loss of 5.6 kg between the liraglutide group and the placebo group is more than what was observed in previous studies of GLP-1 mimetics," says an editorial article about the findings in the same issue of the medical journal. Written by Dr. About Anafranil Sr (Clomipramine) with no Rx Elias Siraj and Dr. About Wellbutrin Sr (Bupropion) with no Rx Kevin Williams, the editorial explains that GLP-1 mimetics: Stimulate insulin secretion Lower postmeal glucagon levels Slow gastric emptying Reduce appetite. The weight loss achieved with liraglutide was maintained over 56 weeks. Buy Glucophage (Metformin) with no prescription A greater proportion of patients (63.2%) taking the daily drug than taking a placebo (27.1%) lost at least 5% of their body weight. Also, 33.1% of participants taking liraglutide lost 10% of their body weight, compared with 10.6% of participants taking a placebo. Buy Clopivas without Rx Fifteen percent of body weight was lost by 14.4% of the patients taking liraglutide and 3.5% of the placebo group. Liraglutide joins three other prescription drugs to have won approval from the Food and Drug Administration for use in weight loss in the past 3 years: lorcaserin (Belviq, a serotonin 2C receptor agonist); phentermine, a sympathomimetic amine anorectic, combined with topiramate, an antiepileptic (Qsymia); and naltrexone, an opioid antagonist, combined with bupropion, an aminoketone antidepressant (Contrave). No obesity cure No new safety concerns were identified in the trial for liraglutide, and the side effects observed were consistent with those in previous reports. The most common side effects were gastrointestinal and mild. "Given previous disappointments with various weight-loss strategies, these are welcome findings," conclude Drs. Cialis Pack-90 () without Rx Siraj and Williams. "Still, liraglutide is no cure. Buy Motherwort online Most obese participants stayed obese, reversal of the metabolic syndrome was not quantified, and liraglutide may be required indefinitely, like statins, but with delivery by injection and at a nontrivial cost." "Undoing the detrimental influences of our new environment requires practical strategies for eating less and moving more. http://asthmareview.wordpress.com Fortunately, even modest loss of body weight of 5% to 10% makes nearly all medical issues more manageable. "On the basis of the current study, modest weight loss may now be easier to achieve, yet we await the results from studies with longer follow-up." Written by Markus MacGill

Latent HIV cells only 'wake up' once a week following antiretrovirals

A new study published in PLOS Pathogens provides new insight into how often HIV cells "wake up" among individuals undergoing antiretroviral therapy for the virus, bringing researchers one step closer to getting patients off the treatment for good and into remission. A new study finds after antiretroviral therapy, latent HIV cells only wake up once a week. About Levitra Professional (Vardenafil) Previously, it was thought they awoke four to five times a week. The study was conducted by Prof. Anafranil Sr (Clomipramine) with no Rx Miles Davenport and colleagues from the Kirby Institute at the University of New South Wales (UNSW) in Australia. Worldwide, there are around 35 million people living with HIV (human immunodeficiency virus), with the majority of these residing in Sub-Saharan Africa. About Tiova (Tiotropium Bromide) with no prescription According to the World Health Organization (WHO), there has been a significant increase in the number of people with HIV receiving antiretroviral therapy (ART) in recent years, with more than 2 million individuals newly enrolled to the treatment in 2013. There is no doubt that ART - which involves the use of three or more drugs to stop HIV cells reproducing - has proved an effective prevention and treatment strategy for HIV. About Cilamin with free prescription WHO say the likelihood of an HIV-infected individual transmitting the virus to their partner is reduced by 96% if they are receiving the treatment. But Prof. Buy Ditropan Xl (Oxybutynin) Davenport notes researchers in the field of HIV are working toward bigger objectives. Buy Liquid Vitamin E online "At the moment we have very successful drug treatments for HIV, but a broader goal is to get people off antiretroviral therapy entirely," he says. Latent HIV cells awake 24 times less than previously thought Previously, researchers thought that among individuals with HIV who had completed antiretroviral therapy (ART), latent HIV cells - infected cells that reproduce at low levels - awoke around four or five times daily. In order for a patient to enter remission - where no symptoms are displayed - for an average of 1 year, researchers estimated that the number of latent HIV cells would need to be reduced by around 2,000 times. However, the study from Prof. http://medicalhelper.wordpress.com Davenport and colleagues reveals that HIV cells only awake once a week after ART is ceased - around 24 times less than previously thought - meaning the number of latent HIV cells needed to produce a 1-year remission period would only need to be reduced by around 50-70 times. "Researchers have been looking at ways of reducing the amount of latent HIV infection in the body, in the hopes of creating a remission so that drug therapy can be suspended," says Prof. Davenport, "but until now we didn t know exactly how long it takes for the latent HIV cells to reactivate and start infecting other cells again after treatment is suspended." "Our findings represent an important advance in our knowledge about how HIV works," he adds. Findings provide a more accurate target for HIV remission To reach their findings, the team analyzed data from the Kirby Institute s PULSE study and three other studies involving patients with HIV undergoing ART therapy. The researchers combined all the data and applied mathematical modeling and statistical analysis to estimate the average frequency of viral rebound among the patients following ART. Across all four studies, the team found that latent HIV cells "wake up" an average of once every 5-8 days - a finding they say brings researchers closer to getting HIV patients off ART completely. Prof. Davenport says: "While it was previously thought the latent virus woke up many times a day during treatment, we now know that that latently infected cells wake up on average only once a week when treatment has been suspended. For the first time, we have a measurement of how much we will need to reduce the viral reservoir to produce HIV remission. Essentially, we now have a more accurate target to aim for." Earlier this week, Medical News Today reported that WHO has validated Cuba as the first country to eliminate mother-to-child transmission of HIV and syphilis. Written by Honor Whiteman