SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) today announced that nearly 30 combination studies including IMiD® compounds, REVLIMID® (lenalidomide) and POMALYST®/IMNOVID® (pomalidomide), across a range of patient segments within multiple myeloma are being presented at the 57th American Society of Hematology Annual Meeting (ASH). In the U.S., REVLIMID in combination with dexamethasone is approved for patients with multiple myeloma and POMALYST in combination with dexamethasone is approved for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. Buy Levaquin (Levofloxacin) with no prescription These treatments are the subject of important investigational studies in combination with investigational and approved agents. “At ASH this year, we are encouraged to see our IMiD® therapies forming the backbone for combination treatments in multiple myeloma, including new classes such as monoclonal antibodies, immunotherapy agents and epigenetic therapies,” said Jacqualyn A. Micronase (Glyburide(Glibenclamide)) without prescription Fouse, President Hematology/Oncology for Celgene. About Geriforte () “We have already seen recent approvals in the treatment of relapsed multiple myeloma that are using REVLIMID and dexamethasone as a backbone of their therapy. Buy Ipravent with no Rx These approvals and the important research presented here at ASH have the potential to further advance the treatment of this serious disease.” Some of the studies presented at ASH include: REVLIMID-based Combinations: Bortezomib, Lenalidomide and Dexamethasone vs. About Bupron SR (Bupropion ) Lenalidomide and Dexamethasone in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant: Results of the Randomized Phase 3 Trial SWOG S0777 ELOQUENT-2 Update: A Phase 3, Randomized, Open-Label Study of Elotuzumab in Combination with Lenalidomide/Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma – 3-Year Follow-up Efficacy and Safety of Carfilzomib, Lenalidomide, and Dexamethasone vs. Buy Immune System online Lenalidomide and Dexamethasone in Patients with Relapsed Multiple Myeloma Based on Cytogenetic Risk Status: Subgroup Analysis from the Phase 3 Study, Aspire (NCT01080391) Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in Combination with Lenalidomide and Dexamethasone (IRd), Significantly Extends Progression-Free Survival for Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma: The Phase 3 Tourmaline-MM1 Study (NCT01564537) Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma: Updated Results of a Phase 1/2 Study (GEN503) A Phase 2 Study of Modified Lenalidomide, Bortezomib, and Dexamethasone (RVD-lite) for Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma Pembrolizumab in Combination with Lenalidomide and Low-Dose Dexamethasone for Relapsed/Refractory Multiple Myeloma: Keynote-023 First Interim Results of a Phase 1/2 Study of Lenalidomide in Combination with Anti-PD-1 Monoclonal Antibody MDV9300 (CT-011) in Patients with Relapsed/Refractory Multiple Myeloma Phase 1/2 Trial of the Efficacy and Safety of Combination Therapy with Lenalidomide/Bortezomib/Dexamethasone (RVD) and Panobinostat in Transplant-Eligible Patients with Newly Diagnosed Multiple Myeloma A Phase 2 Study of Panobinostat with Lenalidomide and Weekly Dexamethasone in Myeloma Phase 1 Dose-Escalation Study of Sotatercept (ACE-011) in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma POMALYST-based Combinations: A Phase 2 Study of Anti PD-1 Antibody Pembrolizumab, Pomalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Open-Label, Multicenter, Phase 1b Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Patients with at Least 2 Lines of Prior Therapy and Relapsed or Relapsed and Refractory Multiple Myeloma Alliance A061202. http://asthmareview.wordpress.com A Phase 1/2 Study Of Pomalidomide, Dexamethasone And Ixazomib Versus Pomalidomide And Dexamethasone For Patients With Multiple Myeloma Refractory To Lenalidomide And Proteasome Inhibitor Based Therapy: Phase 1 Results A Phase 1, Multicenter Study of Pomalidomide, Bortezomib, and Low-Dose Dexamethasone in Patients with Proteasome Inhibitor–Exposed and Lenalidomide-Refractory Myeloma (trial MM-005) ClaPd (Clarithromycin, Pomalidomide, Dexamethasone) therapy in relapsed or refractory multiple myeloma overcomes negative prognostic impact of adverse cytogenetics and prior resistance to lenalidomide and bortezomib Oprozomib, Pomalidomide, and Dexamethasone (OPomd) in Patients with Relapsed and/or Refractory Multiple Myeloma: Initial Results of a Phase 1b Study (NCT01999335) About REVLIMID® In the United States, REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand. REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. In addition, REVLIMID is approved in the United States for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. U.S. Regulatory Information for REVLIMID® REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM) REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib REVLIMID is not indicated and not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials REVLIMID® and POMALYST®/IMNOVID® are registered trademarks of Celgene Corporation Important Safety Information WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS® program (formerly known as the “RevAssist®”program). Information about the REVLIMID REMS® program is available at .celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia) REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors. Venous and Arterial Thromboembolism REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks. CONTRAINDICATIONS Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus Allergic Reactions: REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: REVLIMID is an analogue of thalidomide, a known human teratogen that causes life-threatening human birth defects or embryo-fetal death. An embryo-fetal development study in monkeys indicates that lenalidomide produced malformations in offspring of female monkeys who received drug during pregnancy, similar to birth defects observed in humans following exposure to thalidomide during pregnancy Females of Reproductive Potential: Must avoid pregnancy for at least 4 weeks before beginning REVLIMID therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control beginning 4 weeks prior to initiating treatment with REVLIMID, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of REVLIMID. Must obtain 2 negative pregnancy tests prior to initiating therapy Males: Lenalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 28 days after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Male patients taking REVLIMID must not donate sperm Blood Donation: Patients must not donate blood during treatment with REVLIMID and for 1 month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must note exposed to REVLIMID REVLIMID REMS® Program Because of embryo-fetal risk, REVLIMID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) the REVLIMID REMS® Program (formerly known as the “RevAssist®” Program). Prescribers and pharmacies must be certified with the program and patients must sign an agreement form and comply with the requirements. Further information about the REVLIMID REMS® program is available at .celgeneriskmanagement.com or by telephone at 1-888-423-5436 Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction. MDS: See Boxed WARNINGS Venous and Arterial Thromboembolism: Venous thromboembolic events (DVT and PE) and arterial thromboses are increased in patients treated with REVLIMID. A significantly increased risk of DVT (7.4%) and PE (3.7%) occurred in patients with MM after at least one prior therapy, treated with REVLIMID/dex compared to placebo/dex (3.1% and 0.9%) in clinical trials with varying use of anticoagulant therapies. In NDMM study, in which nearly all patients received antithrombotic prophylaxis, DVT (3.6%) and PE (3.8%) were reported in the Rd continuous arm. Myocardial infarction (MI,1.7%) and stroke (CVA,2.3%) are increased in patients with MM after at least 1 prior therapy who were treated with REVLIMID/dex therapy compared with placebo/dex (0.6%, and 0.9%) in clinical trials. In NDMM study, MI (including acute) was reported (2.3%) in the Rd Continuous arm. Frequency of serious adverse reactions of CVA was (0.8%) in the Rd Continuous arm. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g. hyperlipidemia, hypertension, smoking). In controlled clinical trials that did not use concomitant thromboprophylaxis, 21.5% overall thrombotic events occurred in patients with refractory and relapsed MM who were treated with REVLIMID/dex compared to 8.3% thrombosis in the placebo/dex group. Median time to first thrombosis event was 2.8 months. In NDMM study, which nearly all patients received antithrombotic prophylaxis, overall frequency of thrombotic events was 17.4% in combined Rd continuous and Rd18 arms. Median time to first thrombosis event was 4.37 months. Thromboprophylaxis is recommended and regimen is based on patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision. See Boxed WARNINGS Increased Mortality in Patients With CLL: In a clinical trial in the first line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. In an interim analysis, there were 34 deaths among 210 patients on the REVLIMID treatment arm compared to 18 deaths among 211 patients in the chlorambucil treatment arm, and hazard ratio for overall survival was 1.92 [95% CI: 1.08-3.41] consistent with a 92% increase in risk of death. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure occurred more frequently in the REVLIMID treatment arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials Second Primary Malignancies: In clinical trials in patients with MM receiving REVLIMID, an increase of invasive second primary malignancies notably AML and MDS have been observed. The increase of AML and MDS occurred predominantly in NDMM patients receiving REVLIMID in combination with oral melphalan (5.3%) or immediately following high dose intravenous melphalan and ASCT (up to 5.2%). The frequency of AML and MDS cases in the Revlimid/dex arms was observed to be 0.4%. Cases of B-cell malignancies (including Hodgkin’s Lymphomas) were observed in clinical trials where patients received lenalidomide in the post-ASCT setting. Patients who received REVLIMID-containing therapy until disease progression did not show a higher incidence of invasive SPM than patients treated in the fixed duration REVLIMID-containing arms. Monitor patients for the development of second primary malignancies. Take into account both the potential benefit and risk of second primary malignancies when considering treatment with REVLIMID Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with lenalidomide in combination with dex. The mechanism of drug-induced hepatotoxicity is unknown. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered Allergic Reactions: Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions. REVLIMID capsules contain lactose. Risk-benefit of REVLIMID treatment should be evaluated in patients with lactose intolerance Tumor Lysis Syndrome: Fatal instances of tumor lysis syndrome (TLS) have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken Tumor Flare Reaction: Tumor flare reaction (TFR) has occurred during investigational use of lenalidomide for CLL and lymphoma, and is characterized by tender lymph node swelling, low grade fever, pain and rash. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with lenalidomide until TFR resolves to =20% of NDMM patients in Arm Rd Continuous: diarrhea (45.5%), anemia (43.8%), neutropenia (35%), fatigue (32.5%), back pain (32%), insomnia (27.6%), asthenia (28.2%), rash (26.1%), decreased appetite (23.1%), cough (22.7%), pyrexia (21.4%), muscle spasms (20.5%), and abdominal pain (20.5%). The frequency of onset of cataracts increased over time with 0.7% during the first 6 months and up to 9.6% by the second year of treatment with Arm Rd Continuous After at least one prior therapy most adverse reactions and Grade 3/4 adverse reactions were more frequent in MM patients who received the combination of REVLIMID/dex compared to placebo/dex. Grade 3 or 4 adverse reactions included neutropenia 33.4% vs 3.4%, febrile neutropenia 2.3% vs 0%, DVT 8.2% vs 3.4% and PE 4% vs 0.9% respectively Adverse reactions reported in >=15% of MM patients (REVLIMID/dex vs dex/placebo): fatigue (44% vs 42%), neutropenia (42% vs 6%), constipation (41% vs 21%), diarrhea (39% vs 27%), muscle cramp (33% vs 21%), anemia (31% vs 24%), pyrexia (28% vs 23%), peripheral edema (26% vs 21%), nausea (26% vs 21%), back pain (26% vs 19%), upper respiratory tract infection (25% vs 16%), dyspnea (24% vs 17%), dizziness (23% vs 17%), thrombocytopenia (22% vs 11%), rash (21% vs 9%), tremor (21% vs 7%), weight decreased (20% vs 15%), nasopharyngitis (18% vs 9%), blurred vision (17% vs 11%), anorexia (16% vs 10%), and dysgeusia (15% vs 10%) Myelodysplastic Syndromes Grade 3 and 4 adverse events reported in >= 5% of patients with del 5q MDS were neutropenia (53%), thrombocytopenia (50%), pneumonia (7%), rash (7%), anemia (6%), leukopenia (5%), fatigue (5%), dyspnea (5%), and back pain (5%) Adverse events reported in >=15% of del 5q MDS patients (REVLIMID): thrombocytopenia (61.5%), neutropenia (58.8%), diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%), dyspnea (17%), pharyngitis (16%), epistaxis (15%), asthenia (15%), upper respiratory tract infection (15%) Mantle Cell Lymphoma Grade 3 and 4 adverse events reported in >=5% of patients treated with REVLIMID in the MCL trial (N=134) included neutropenia (43%), thrombocytopenia (28%), anemia (11%), pneumonia (9%), leukopenia (7%), fatigue (7%), diarrhea (6%), dyspnea (6%), and febrile neutropenia (6%) Serious adverse events reported in >=2 patients treated with REVLIMID monotherapy for MCL included chronic obstructive pulmonary disease, clostridium difficile colitis, sepsis, basal cell carcinoma, and supraventricular tachycardia Adverse events reported in >=15% of patients treated with REVLIMID in the MCL trial included neutropenia (49%), thrombocytopenia (36%), fatigue (34%), anemia (31%), diarrhea (31%), nausea (30%), cough (28%), pyrexia (23%), rash (22%), dyspnea (18%), pruritus (17%), peripheral edema (16%), constipation (16%), and leukopenia (15%) DRUG INTERACTIONS Periodic monitoring of digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of REVLIMID. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in MM patients taking concomitant warfarin. Erythropoietic agents, or other agents, that may increase the risk of thrombosis, such as estrogen containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving REVLIMID USE IN SPECIFIC POPULATIONS Pregnancy: If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure to REVLIMID must be reported to the FDA via the MedWatch program at 1-800-332-1088 and also to Celgene Corporation at 1-888-423-5436 Nursing Mothers: It is not known whether REVLIMID is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother Pediatric Use: Safety and effectiveness in patients below the age of 18 have not been established Renal Impairment: Since REVLIMID is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID are recommended to provide appropriate drug exposure in patients with moderate (CLcr 30-60 mL/min) or severe renal impairment (CLcr < 30 mL/min) and in patients on dialysis Please see accompanying full Prescribing Information, including Boxed WARNINGS. About POMALYST® POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. Important Safety Information WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment. POMALYST is only available through a restricted distribution program called POMALYST REMS®. Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors. CONTRAINDICATIONS: Pregnancy POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity Females of Reproductive Potential: Must avoid pregnancy while taking POMALYST and for at least 4 weeks after completing therapy. Must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with POMALYST, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of POMALYST therapy. Must obtain 2 negative pregnancy tests prior to initiating therapy Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 28 days after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm Blood Donation: Patients must not donate blood during treatment with POMALYST and for 1 month following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST POMALYST REMS® Program Because of the embryo-fetal risk, POMALYST is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called “POMALYST REMS®.” Prescribers and pharmacies must be certified with the program; patients must sign an agreement form and comply with the requirements. Further information about the POMALYST REMS® program is available at .CelgeneRiskManagement.com or by telephone at 1-888-423-5436. Venous and Arterial Thromboembolism: Venous thromboembolic events (DVT and PE) and arterial thromboembolic events (ATE) (myocardial infarction and stroke) have been observed in patients treated with POMALYST. In Trial 2, where anticoagulant therapies were mandated, thromboembolic events occurred in 8.0% of patients treated with POMALYST and low dose-dexamethasone (Low-dose Dex) vs 3.3% treated with high-dose dexamethasone. Venous thromboembolic events (VTE) occurred in 4.7% of patients treated with POMALYST and Low-dose Dex vs 1.3% treated with high-dose dexamethasone. Arterial thromboembolic events include terms for arterial thromboembolic events, ischemic cerebrovascular conditions, and ischemic heart disease. Arterial thromboembolic events occurred in 3.0% of patients treated with POMALYST and Low-dose Dex vs 1.3% treated with high-dose dexamethasone. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Hematologic Toxicity: In trials 1 and 2 in patients who received POMALYST + Low-dose Dex, neutropenia (46%) was the most frequently reported Grade 3/4 adverse reaction, followed by anemia and thrombocytopenia. Monitor patients for hematologic toxicities, especially neutropenia. Monitor complete blood counts weekly for the first 8 weeks and monthly therafter. Patients may require dose interruption and/or modification. Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered. Hypersensitivity Reactions: Angioedema and severe dermatologic reactions have been reported. Discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reactions, and do not resume therapy. Dizziness and Confusional State: In trials 1 and 2 in patients who received POMALYST + Low-dose Dex, 14% experienced dizziness and 7% a confusional state; 1% of patients experienced Grade 3 or 4 dizziness and 3% experienced a Grade 3 or 4 confusional state. Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice. Neuropathy: In trials 1 and 2, patients who received POMALYST + Low-dose Dex experienced neuropathy (18%) and peripheral neuropathy (~12%). In trial 2, 2% of patients experienced Grade 3 neuropathy. Risk of Second Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma. Tumor Lysis Syndrome: Tumor lysis syndrome (TLS) may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken. ADVERSE REACTIONS Nearly all patients treated with POMALYST + Low-dose Dex experienced at least one adverse reaction (99%). In trial 2, the most common adverse reactions included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), edema peripheral (17.3%), peripheral neuropathy (17.3%), bone pain (18%), nausea (15%), and muscle spasms (15.3%). Grade 3 or 4 adverse reactions included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%). DRUG INTERACTIONS Pomalidomide is primarily metabolized by CYP1A2 and CYP3A. Pomalidomide is also a substrate for P-glycoprotein (P-gp). Avoid the use of strong CYP1A2 inhibitors. If medically necessary to co-administer strong inhibitors of CYP1A2 in the presence of strong inhibitors of CYP3A4 and P-gp, reduce POMALYST dose by 50%. Cigarette smoking may reduce pomalidomide exposure due to CYP1A2 induction. Patients should be advised that smoking may reduce the efficacy of pomalidomide. USE IN SPECIFIC POPULATIONS Pregnancy: If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch ogram at 1-800-332-1088 and also to Celgene Corporation at 1-888-423-5436. Nursing Mothers: It is not known if pomalidomide is excreted in human milk. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from POMALYST, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of POMALYST in patients under the age of 18 have not been established. Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients

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FOSTER CITY, Californi"e--(BUSINESS WIRE)--Gilead Sciences, Inc. Symmetrel (Amantadine) with free Rx (Nasdaq: GILD) heeft vandaag uitgebreide resultaten bekendgemaakt van het AMBITION-onderzoek (een gerandomiseerd, dubbelblind, in meerdere centra uitgevoerd onderzoek van de eerstelijns combinatietherapie met AMBrIsentan en Tadalafil bij pati"enten met pulmonale arteri"ele hypertensie (pulmonary arterial hypertensION)). Cytoxan (Cyclophosphamide) with no Rx In AMBITION, uitgevoerd in samenwerking met GlaxoSmithKline (GSK), verlaagde de combinatietherapie met Letairis® (ambrisentan) en tadalafil het risico op klinisch falen met 50 procent vergeleken met de gepoolde Letairis- en tadalafil-monotherapiegroep (hazard ratio = 0,50; 95 procent BI: 0,35, 0,72; p < 0,001). Buy Trimox (Amoxicillin) with free Rx Deze gegevens werden gepubliceerd in The New England Journal of Medicine. Letairis, een selectieve endotheline type-A receptor-antagonist, en tadalafil, een PDE5-remmer, zijn beide goedgekeurd in de Verenigde Staten (VS), de Europese Unie (EU) en andere landen als eenmaaldaagse behandelingen voor pati"enten met pulmonale arteri"ele hypertensie (PAH) (WHO Groep 1) met WHO/NYHA functieklasse II- en III-symptomen. About Epinastine HCl without Rx Letairis is in de VS ge"indiceerd voor het verbeteren van het vermogen tot lichaamsbeweging en de vertraging van klinische verslechtering en in de EU onder de handelsnaam Volibris® ter verbetering van de lichaamsbewegingscapaciteit. About Pletal (Cilostazol) without prescription Tadalafil 40 mg is in de VS en de EU ge"indiceerd voor het verbeteren van respectievelijk het vermogen en de capaciteit van lichaamsbeweging. Buy Bilberry Tea online Preklinische gegevens hebben gesuggereerd dat deze therapie"en synergistische effecten zouden kunnen hebben. http://medical-reviews.blogspot.com Gecombineerd gebruik van Letairis en tadalafil is echter momenteel niet goedgekeurd. “Het enige andere gepubliceerde, grootschalige, voorvalgestuurde onderzoek van PAH tot nu vergeleek een endotheline-receptor-antagonist met placebo bij pati"enten die voor de eerste keer werden behandeld of die deze behandeling als achtergrondbehandeling kregen; in AMBITION kregen alle pati"enten echter een goedgekeurde behandeling voor PAH,” aldus Lewis J. Rubin, MD, Emeritus Professor, University of California, San Diego en Co-Chair van de AMBITION Steering Committee. “Het merendeel van het effect met deze combinatie in vergelijking met actieve monotherapie is dus indrukwekkend, met name bij de WHO functieklasse II-pati"enten waar we een verlaging van 80% in risico op klinisch falen waarnamen vergeleken met monotherapie.” AMBITION was een in meerdere centra, gerandomiseerd, dubbelblind fase 3/4-onderzoek opgezet om de veiligheid en werkzaamheid van de onderzoeks-, eerstelijns-, combinatietherapie (Letairis en tadalafil) te vergelijken met eerstelijnsmonotherapie (Letairis of tadalafil) bij pati"enten met WHO/NYHA functieklasse II en III PAH. In de primaire onderzoeksanalyse werden 500 pati"enten (2:1:1) gerandomiseerd aan het krijgen van Letairis en tadalafil (n=253) of monotherapie met Letairis (n=126) of tadalafil (n=121) (respectievelijk getitreerd van 5 mg naar 10 mg eenmaaldaags en van 20 mg naar 40 mg eenmaaldaags voor Letairis en tadalafil). Het primaire eindpunt was tijd tot eerste voorval van klinisch falen, een samengesteld eindpunt dat zowel de traditionele componenten van klinische verslechtering (overlijden, ziekenhuisopname en verslechtering van de ziekte) omvat, als een component van onbevredigende langetermijn- klinische respons (alle voorvallen beoordeeld door een onafhankelijke, geblindeerde commissie). Het behandelingseffect voor het samengestelde primaire eindpunt van tijd tot klinisch falen werd voornamelijk gestuurd door een gereduceerd aantal ziekenhuisopnames vanwege PAH, met een verlaagd risico op ziekenhuisopname voor PAH van 63 procent (hazard ratio = 0,37; 95 procent BI: 0,22, 0,64; p < 0,001). Consistent gunstige verminderingen van voorvallen van klinisch falen werden waargenomen gebaseerd op etiologie, WHO functieklasse, leeftijd, geografisch gebied en sekse. De vooraf gedefinieerde subgroepanalyse van het primaire eindpunt suggereerde dat pati"enten met WHO functieklasse II (n=155; hazard ratio = 0,21; 95 procent BI: 0,07, 0,63); p = 0,005) nog positiever reageerden dan pati"enten met WHO functieklasse III (n=345; hazard ratio = 0,58; 95 procent BI: 0,39, 0,86; p = 0,006). Statistisch significante verbeteringen werden ook waargenomen met de volgende secundaire eindpunten, vergeleken met de gepoolde monotherapiegroep: verandering van baseline tot week 24 in N-terminal pro-B-type natriuretisch peptide (NT-proBNP) (-67 procent vs. -50 procent; p < 0,001), percentage pati"enten met bevredigende klinische respons op week 24 (39 procent vs. 29 procent; odds ratio 1,56; p = 0,03) en mediaanverandering van baseline tot week 24 in zes-minuten-loopafstand (six-minute walk distance, 6MWD) (49 meter vs. 24 meter; p < 0,001). Er was geen verandering tussen de behandelgroepen vanaf de baseline tot week 24 voor de WHO functieklasse. Met de combinatie van Letairis en tadalafil werden geen nieuwe veiligheidssignalen gedetecteerd. Bijwerkingen die vaker optreden in de combinatiegroep dan in beide monotherapiegroepen waren perifeer oedeem (combinatie: 45 procent; Letairis: 33 procent; tadalafil: 28 procent), hoofdpijn (combinatie: 42 procent; Letairis: 33 procent; tadalafil: 35 procent), neusverstopping (combinatie: 21 procent; Letairis: 15 procent; tadalafil: 12 procent) en anemie (combinatie: 15 procent; Letairis: 6 procent; tadalafil: 12 procent). Aanvullende onderzoeksresultaten zijn beschikbaar op .nejm.org. Gilead diende de gegevens van AMBITION in in een aanvullende nieuwe geneesmiddelaanvraag (supplemental new drug application, sNDA) voor Letairis bij de U.S. Food and Drug Administration (FDA) op 5 december 2014. De FDA heeft een standaardtoetsing toegekend en heeft een beoogde toetsingsdatum vastgesteld in overeenstemming met de Prescription Drug User Fee Act (PDUFA) van 5 oktober 2015. In de VS heeft Letairis een gelabelde OMKADERDE WAARSCHUWING en een daarmee in verband staand risicobeoordelings- en mitigatiestrategieprogramma (Risk Evaluation and Mitigation Strategy, REMS) met betrekking tot het risico op embryofoetale toxiciteit; zie hieronder voor belangrijke veiligheidsinformatie voor de VS voor Letairis. Over AMBITION AMBITION werd door Gilead en GSK gezamenlijk gesponsord. Eli Lilly and Company hebben voor het onderzoek ook financiering verstrekt en het geneesmiddel tadalafil geleverd. Gilead verhandelt ambrisentan in de VS onder de handelsnaam Letairis en GSK verhandelt ambrisentan onder de handelsnaam Volibris® in gebieden buiten de Verenigde Staten. Over pulmonale arteri"ele hypertensie (WHO Groep 1) PAH is een slopende ziekte die wordt gekenmerkt door vernauwing van de bloedvaten in de longen, wat leidt tot hoge pulmonale arteri"ele drukken. Deze hoge drukken maken het voor het hart moeilijk om bloed door de longen te pompen om deze van zuurstof te voorzien. Pati"enten met PAH lijden aan kortademigheid omdat het het hart veel moeite kost tegen deze hoge drukken in te pompen, wat voor deze pati"enten uiteindelijk leidt tot overlijden door hartfalen. PAH kan zich zonder bekende onderliggende oorzaak voordoen of secundair ontstaan bij ziekten als bindweefselziekte, congenitale hartdefecten, levercirrose en hiv-infectie. Belangrijke veiligheidsinformatie voor de VS voor Letairis OMKADERDE WAARSCHUWING: EMBRYOFOETALE TOXICITEIT Dien Letairis niet toe aan een zwangere vrouw omdat het schade aan de foetus kan veroorzaken. Het is zeer waarschijnlijk dat Letairis ernstige geboortedefecten kan veroorzaken als zwangere vrouwen het middel gebruiken omdat dit effect constant wordt gezien wanneer het wordt toegediend aan dieren. Sluit zwangerschap uit voorafgaand aan het begin van de behandeling met Letairis. Vrouwen die zwanger kunnen worden moeten aanvaarde methoden van anticonceptie gebruiken tijdens de behandeling en gedurende een maand na de behandeling. Voer maandelijks zwangerschaptesten uit tijdens de behandeling en 1 maand na het staken van de behandeling. Vanwege het risico op geboortedefecten door embryofoetale toxiciteit, kunnen vrouwen uitsluitend Letairis krijgen via een begrensd programma dat het Letairis REMS-programma wordt genoemd. Contra-indicaties Dien Letairis niet toe aan een zwangere vrouw omdat het schade aan de foetus kan veroorzaken. Letairis is gecontra"indiceerd voor pati"enten met idiopathische pulmonale fibrose (IPF), waaronder IPF-pati"enten met pulmonale hypertensie (WHO Groep 3). Waarschuwingen en voorzorgsmaatregelen Embryofoetale toxiciteit: Letairis kan schade aan de foetus veroorzaken als het tijdens de zwangerschap wordt toegediend. Letairis REMS-programma: Voor alle vrouwen is Letairis slechts beschikbaar via een begrensd programma dat Letairis REMS wordt genoemd. Enkele vereisten van het Letairis REMS-programma zijn: Voorschrijvers moeten voor het programma gecertificeerd zijn door het volgen en voltooien van training. Alle vrouwen moeten, ongeacht of ze zwanger kunnen worden, voorafgaand aan het starten met Letairis het Letairis REMS-programma volgen. Mannelijke pati"enten worden niet in de REMS ingeschreven.Apotheken die Letairis bereiden en leveren moeten gecertificeerd zijn voor het programma en moeten het middel leveren aan vrouwelijke pati"enten die geautoriseerd zijn om Letairis te ontvangen. Aanvullende informatie is beschikbaar via .letairisrems.com of 1-866-664-5327. Licht tot matig perifeer oedeem: Perifeer oedeem trad vaker op bij oudere pati"enten (leeftijd >= 65 jaar) die Letairis ontvangen (29 procent; 16/56) vergeleken met placebo (4 procent; 1/28). Perifeer oedeem is bekend als een klasse-effect van endotheline-receptorantagonisten. Daarnaast zijn er nadat het middel in de handel is gebracht meldingen geweest van vochtretentie die binnen weken na de start met Letairis optraden en die interventie met een diureticum, vochtbeheersing of, in sommige gevallen, ziekenhuisopname in verband met hartfalen vereisten. Pulmonaal oedeem met PVOD (pulmonale veno-occlusieve ziekte): Als pati"enten acuut pulmonaal oedeem ontwikkelen tijdens de start van de behandeling met vasodilaterende stoffen zoals Letairis moet pulmonale veno-occlusieve ziekte worden overwogen en indien bevestigd, moet Letairis worden gestaakt. Een afname in spermatelling is waargenomen bij pati"enten die endothelinereceptor-antagonisten namen en in dieronderzoek naar vruchtbaarheid met ambrisentan. Adviseer pati"enten over de potenti"ele effecten op vruchtbaarheid. Hematologische veranderingen: Afnames in hemoglobine zijn waargenomen binnen de eerste paar weken behandeling met Letairis en kan tijdens de behandeling voortduren. Er zijn nadat het middel in de handel is gebracht meldingen van anemie geweest die bloedtransfusie vereisten. Meet het hemoglobine voor de start, na 1 maand en daarna periodiek. Starten met Letairis-behandeling wordt niet aanbevolen voor pati"enten met klinisch significante anemie. Bijwerkingen Vaakst voorkomende bijwerkingen (> 3% vergeleken met placebo)       Placebo (N=132)     LETAIRIS (N=261) Bijwerking n (%) n (%)     Aangepast voor placebo (%) Perifeer oedeem 14 (11) 45 (17) 6 Neusverstopping 2 (2) 15 (6) 4 Sinusitis 0 (0) 8 (3) 3 Opvliegers 1 (1) 10 (4) 3   Tijdens de 12-weken durende gecontroleerde klinische onderzoeken was de incidentie van leveraminotransferase-verhogingen (AST, ALT) >3x ULN (upper limit of normal), 0 procent voor Letairis en 2,3 procent voor placebo. Nadat het middel in de handel is gebracht is melding gemaakt van verhogingen van aminotransferases bij gebruik van Letairis; in de meeste gevallen konden alternatieve oorzaken van leverletsel worden vastgesteld (hartfalen, hepatische congestie, hepatitis, alcoholgebruik, hepatotoxische medicaties). In de praktijk moeten gevallen van hepatisch letsel zorgvuldig worden ge"evalueerd wat betreft oorzaak. Andere ERA s zijn geassocieerd met aminotransferaseverhogingen, hepatotoxiciteit en gevallen van leverfalen. Stop met Letairis als de aminotransferaseverhogingen >5x ULN zijn of als verhogingen gepaard gaan met een bilirubine van >2x ULN of door tekenen van symptomen van leverdisfunctie en andere oorzaken zijn uitgesloten. Geneesmiddelinteracties Gelijktijdige toediening van meerdere doses Letairis en cyclosporine resulteerden in een circa tweevoudige toename van blootstelling aan Letairis bij gezonde vrijwilligers. Beperk de dosis Letairis naar 5 mg eenmaaldaags als dit middel samen met cyclosporine wordt toegediend. Dosering en toediening Dosering voor volwassenen: Begin de behandeling op 5 mg eenmaaldaags en overweeg het verhogen van de dosis naar 10 mg eenmaaldaags als 5 mg wordt verdragen. Tabletten kunnen ingenomen worden met of zonder voedsel. Tabletten moeten niet worden doorgebroken, fijngestampt of gekauwd. Doses hoger dan eenmaaldaags 10 mg zijn bij pati"enten met pulmonale arteri"ele hypertensie (PAH) niet onderzocht. Testen van de zwangerschap bij vrouwen in de vruchtbare leeftijd: Begin de behandeling met Letairis bij vrouwen in de vruchtbare leeftijd alleen na een negatieve zwangerschapstest. Verkrijg gedurende de behandeling maandelijks een zwangerschapstest. Niet aanbevolen voor pati"enten met een matige of ernstige leverbeschadiging. Er is geen informatie over het gebruik van Letairis bij pati"enten met lichte leverbeschadiging; hoewel blootstelling aan Letairis bij deze pati"enten verhoogd kan zijn. Over Gilead Sciences Gilead Sciences is een biofarmaceutisch bedrijf dat innovatieve behandelingen ontdekt, ontwikkelt en op de markt brengt voor medische behoeften waar nog geen oplossingen voor zijn. De missie van het bedrijf is om wereldwijd de zorg te verbeteren voor pati"enten die aan levensbedreigende ziekten lijden. Gilead heeft bedrijven in meer dan 30 landen wereldwijd en het hoofdkantoor is gevestigd in Foster City, Californi"e. Toekomstgerichte verklaring Dit persbericht bevat toekomstgerichte verklaringen (forward-looking statements) binnen de betekenis van de Private Securities Litigation Reform Act van 1995, die onderworpen zijn aan risico s, onzekerheden en andere factoren, waaronder het risico dat de FDA en andere registratie-agentschappen sNDA niet goedkeuren of niet goedkeuren binnen de momenteel verwachte tijdlijnen. Daarnaast kunnen er voor de goedkeuring voor het in de handel brengen, indien verleend, aanzienlijke beperkingen gelden voor het gebruik. Bovendien zouden artsen, zelfs als het middel is goedgekeurd, het voordeel van de combinatietherapie met Letairis en tadalafil niet kunnen zien. Deze risico’s, onzekerheden en andere factoren kunnen ertoe leiden dat de werkelijke resultaten aanzienlijk afwijken van de resultaten zoals die worden genoemd in de toekomstgerichte verklaringen. De lezer wordt gewaarschuwd zich niet te baseren op deze toekomstgerichte verklaringen. Deze en andere risico s staan in detail beschreven in het kwartaalverslag van Gilead op formulier 10-Q voor het kwartaal dat eindigde op 30 juni 2015, zoals ingediend bij de Amerikaanse Securities and Exchange Commission. Alle toekomstgerichte verklaringen zijn gebaseerd op informatie waarover Gilead momenteel beschikt en Gilead neemt geen verplichting op zich om dergelijke toekomstgerichte verklaringen te actualiseren. Volledige voorschrijfinformatie voor de VS voor Letairis, inclusief OMKADERDE WAARSCHUWING, is beschikbaar op .gilead.com. Letairis en Volibris zijn gedeponeerde handelsmerken van Gilead Sciences, Inc., of de aan haar gelieerde bedrijven. Ga voor meer informatie over Gilead Sciences naar de website van het bedrijf: .gilead.com, volg Gilead op Twitter (@GileadSciences) of bel Gilead Public Affairs via nummer 1-800-GILEAD-5 of 1-650-574-3000. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

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DEERFIELD, Ill.--(BUSINESS WIRE)--Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence]. Baxalta is seeking market authorization in Europe of OBIZUR for the treatment of bleeding episodes in adult patients with acquired hemophilia caused by antibodies to Factor VIII (FVIII), a very rare and potentially life-threatening acute bleeding disorder. Buy Nizoral (Ketoconazole) Following this positive opinion, the European Commission is expected to make a decision on the application later this year. Buy Kamagra Effervescent (Sildenafil Citrate) without prescription Upon approval in Europe, OBIZUR will be the first recombinant porcine FVIII treatment available for acquired hemophilia A, allowing physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments. “The marketing authorization anticipated later this year for OBIZUR will be an important milestone, offering patients with acquired hemophilia A in Europe a treatment option that transforms their care by allowing physicians to monitor treatment response,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. About Mircette (Desogestrel / Ethinyl estradiol) with free prescription “The positive support by the European regulators reflects the value this therapy can provide to patients, and supports Baxalta’s long-standing commitment to addressing unmet needs and reducing the global burden of bleeding disorders.” The CHMP positive opinion is based on a global, prospective, controlled, multi-center Phase II/III open-label clinical trial that examined the efficacy of OBIZUR in the treatment of serious bleeding episodes in adults with acquired hemophilia A (29 patients evaluated for safety, 28 evaluated for efficacy). About Dosan with free Rx All patients treated with OBIZUR (28/28) showed a positive response (bleeding stopped or reduced) and clinical improvement, with FVIII activity levels at least greater than 20 percent at 24 hours after the initial infusion. About Tadacip (Tadalafil) with no prescription Resolution of the initial bleeding episode was observed in 24 out of 28 (86 percent) of the patients treated with OBIZUR. Buy Water Bottles online Common adverse reactions observed in greater than five percent of patients in the clinical trial were development of inhibitors to porcine FVIII. OBIZUR is currently approved in the United States and is under regulatory review in Canada, Switzerland, Australia and Colombia. http://doctorconsult.wordpress.com OBIZUR was granted orphan-drug designation by the European Commission based on the classification of acquired hemophilia A as a rare disease and the potential for the treatment to address an important unmet medical need. About OBIZUR in Europe OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] is indicated for the treatment of bleeding episodes in adults with acquired haemophilia caused by antibodies to Factor VIII. OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease. Important Risk Information for OBIZUR CONTRAINDICATIONS OBIZUR should not be used in patients with known anaphylactic reactions to the active substance, hamster protein, or to any of the excipients. WARNINGS & PRECAUTIONS Hypersensitivity Allergic type hypersensitivity reactions are possible with OBIZUR. The product contains trace amounts of hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. In case of shock, standard medical treatment for shock should be implemented. Development of inhibitory antibodies Inhibitory antibodies against porcine Factor VIII (measured using a modification of the Nijmegen variation of the Bethesda assay) were detected before and after exposure to OBIZUR. Inhibitor titres of up to 29 Bethesda units were recorded at baseline yet subjects responded positively to OBIZUR. It is recommended that treatment should be based on clinical judgement and not based on detection of inhibitory antibodies by the Bethesda assay. There is a lack of clinical information on the development of inhibitory antibodies to OBIZUR following repeated administration. Therefore, OBIZUR must only be administered when considered clinically necessary. Extensive cutaneous purpura do not necessarily require treatment. OBIZUR is produced by recombinant DNA technology in baby hamster kidney cells. Antibodies to baby hamster kidney cell protein were not detected in subjects either before or after exposure to OBIZUR. High and sustained Factor VIII activity in blood may predispose to thromboembolic events. Those with pre-existing cardiovascular disease and the elderly are at particular risk. If venous catheterisation is required, the risk of catheter-related complications such as catheter site thrombosis should be considered. Factor VIII activity determined by the chromogenic assay is generally lower than Factor VIII activity determined by the one-stage clotting assay. Measurement of Factor VIII activity must always be carried out using the same assay methodology on any one patient. The one-stage assay is recommended because it has been used in determination of the potency and the mean recovery rate of OBIZUR. Sodium content Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution. To be taken into consideration by patients on a controlled sodium diet. Monitoring Laboratory Tests Monitor Factor VIII activity and clinical condition 30 minutes after the first injection and 3 hours after administering OBIZUR. Monitor Factor VIII activity immediately prior to and 30 minutes after subsequent doses and refer to the table for recommended target Factor VIII trough levels. The one-stage clotting assay for Factor VIII is recommended as it has been used in determination of the potency of OBIZUR and the mean recovery rate. ADVERSE REACTIONS Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII. About Acquired Hemophilia A Acquired hemophilia A is a rare, potentially life-threatening bleeding disorder, which, unlike congenital hemophilia, typically affects older adults and occurs in both males and females1,2. In acquired hemophilia A, individuals typically experience subcutaneous, soft tissue, and post-surgical bleeding.2,3,4 The comorbidities in this typically elderly population also pose a particular challenge to treat serious bleeding episodes.1 About Baxalta Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide. Forward-Looking Statements This release includes forward-looking statements concerning OBIZUR, including expectations with regard to its potential impact on patients, related regulatory actions and commercial launch plans. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Baxalta s control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta s Registration Statement on Form 10 and other Securities and Exchange Commission filings, all of which are available on Baxalta s website. Baxalta expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. REFERENCES 1.   Acquired Hemophilia: Revised Edition. World Federation of Hemophilia. 2012; No. 3: 1-5. Accessed on July 16, 2014. Available at: 1.wfh.org/publication/files/pdf-1186.pdf 2. Musial, J; Zdziarska, J. Acquired hemophilia A: an underdiagnosed, severe bleeding disorder. Department of Hematology, Jagiellonian University Medical College. 2nd Department of Medicine, Jagiellonian University Medical College. 2014. Accessed on July 16, 2014. Available at: pamw.pl/sites/default/files/PAMW%202014-04_Zdziarska.pdf 3. Franchini, M; Gandini, G; Paolantonio, T; Mariani, G. Acquired Hemophilia A; A Concise Review. American Journal of Hematology. 2005. No. 80: 55-63. Accessed on July 16, 2014. Available at: onlinelibrary.wiley.com/doi/10.1002/ajh.20390/pdf 4. Franchini, M; Mannucci, P. Acquired Hemophilia A: A 2013 Update. Department of Transfusion Medicine and Hematology, Carlo Poma Hospital, Mantova, Italy. 2013. Accessed on July 17, 2014. Available at: .ncbi.nlm.nih.gov/pubmed/24008306

Food container plastics linked to hypertension

Chemicals supposed to be safe replacements for harmful chemicals in plastics are linked to hypertension and insulin resistance, a precursor to diabetes, find scientists from NYU Langone Medical Center in New York City. Small rises in blood pressure were linked to the chemicals supposed to replace those previously found to be unsafe. The phthalate compounds in question - di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP) - are replacements for another chemical, di-2-ethylhexylphlatate (DEHP), which the same researchers proved in previous research to have similar adverse effects. The phthalates are meant to strengthen plastic wraps and processed food containers, among other household items. The two new pieces of research are published in the journals Hypertension and The Journal of Clinical Endocrinology and Metabolism. In the Hypertension study, for every 10-fold increase in the amount of phthalates consumed, there was a 1.1 millimeters of mercury (mmHg) increase in blood pressure. In the other study, one in three adolescents with the highest DINP levels had the highest insulin resistance, while for those with the lowest concentrations of the chemicals, only 1 in 4 had insulin resistance. Growing concerns over environmental chemicals and insulin resistance Study leader Dr. About Crixivan (Indinavir) with free Rx Leonardo Trasande, a professor at NYU Langone, says: "Our research adds to growing concerns that environmental chemicals might be independent contributors to insulin resistance, elevated blood pressure and other metabolic disorders." Prof. About Sinemet (Carbidopa-Levodopa) with no prescription Trasande would like the 1976 Toxic Substances Control Act updated: "Our study adds further concern for the need to test chemicals for toxicity prior to their broad and widespread use, which is not required under current federal law." Other research from Prof. Buy Breast Success () without prescription Trasande in 2013 confirmed a link between DEHP exposure and hypertension in Americans. About Cyklokapron with no Rx DEHP was used as a plasticizer but banned in Europe in 2004 - DINP and DIDP are designed to replace it. Buy Arava (Leflunomide) with free prescription Perhaps the safer alternatives lie in not using plastics at all. "Alternatives to DIDP and DINP include wax paper and aluminum wrap; indeed, a dietary intervention that introduced fresh foods that were not canned or packaged in plastic reduced phthalate metabolites substantially." Prof. Buy Progesterone Cream online Trasande adds that there are "safe and simple" steps that can limit exposure to phthalates, including: Do not microwave food in plastic containers or covered by plastic wrap Do not wash plastic food containers in the dishwasher, where plasticizers can leak out Avoid phthalates by avoiding plastic containers labeled with the numbers 3, 6 or 7 inside the recycle symbol. The results of the research come from blood and urine sample analysis of participants in the National Health and Nutrition Examination Survey (NHANES). Since 1999, NHANES has surveyed 5,000 volunteers annually about risk factors and diseases. http://asthmareview.wordpress.com As part of the NYU Langone investigation, blood and urine samples were analyzed from a diverse group of children and adolescents aged between 6 and 19 years. Blood and urine samples were collected once between 2008 and 2012, and the study volunteers blood pressure was similarly measured. Diet, physical activity, gender, race/ethnicity, income, and other factors independently associated with insulin resistance and hypertension were also factored into the researchers analysis. Written by Markus MacGill