http://www.epgonline.org/ article Thu, 09 Feb 2012 09:20:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year Cyberknife, the Intensity Modulated RadioTherapy system from Accuray Inc, can relieve the stabbing pain of the facial nerve condition Trigeminal Neuralgia. Researchers treated 17 patients with Trigeminal Neuralgia with Cyberknife radiosurgery between 2007 and 2009. The patients, who were aged between 36 and 90, had had their symptoms for between one and 11 years and had not responded to the available treatment options. The researchers zapped a 6mm length of trigeminal nerve, just 2 to 3mm from the root, using a maximum radiation dose of 73.06 Gy. The patients were then monitored regularly after the procedure, for an average of just under 12 months. Complete data were available for 16 patients, 14 of whom obtained either partial or complete relief from their symptoms. The average time before symptom relief occurred was just under two months, but varied from three weeks to six months. Four patients relapsed after the procedure, between three and 18 months later. No patient experienced major complications as a result of the procedure, and only two patients reported any sensory side effects. See: >"Cyberknife radiosurgery in treating trigeminal neuralgia" by Bryan M Lazzara et al. Journal of NeuroInterventional Surgery (2012). doi:10.1136/neurintsurg-2011-010125 Wed, 01 Feb 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Cytori Therapeutics has received an Investigational Device Exemption (IDE) approval from the FDA to begin the ATHENA trial using its Celution System. ATHENA will investigate the use of the Celution System to treat a form of Coronary Heart Disease, Chronic Myocardial Ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011. The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options. It will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12-months. Wed, 01 Feb 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Researchers have presented positive results on all efficacy endpoints from the Phase III AFFIRM trial of the investigational drug MDV 3100, from Medivation and Astellas, in men with Prostate Cancer previously treated with chemotherapy. The results, presented at the 2012 Genitourinary Cancers Symposium, show that men taking MDV 3100 lived for a median of 18.4 months, compared with 13.6 months for men taking placebo. MDV 3100 also met all secondary endpoints, including radiographic progression-free survival (8.3 versus 2.9 months; PSA declines of 50% or greater were more common in the MDV 3100 group than in the placebo group (54.0% versus 1.5%; and MDV 3100 was found to be well tolerated. The data was presented by Howard I. Scher, chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center. Wed, 01 Feb 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA has approved Erivedge (vismodegib) from Genentech/Roche to treat adult patients with Basal Cell Carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced Basal Cell Cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic). Erivedge, reviewed under the agency’s priority review program, is the first FDA-approved drug for metastatic Basal Cell Carcinoma. The decision was based on a single, multi-center clinical study (ERIVANCE-BCC) in 96 patients with locally advanced or metastatic Basal Cell Carcinoma where of the patients with metastatic disease receiving Erivedge, 30 percent experienced a partial response and 43 percent of patients with locally advanced disease experienced a complete or partial response. Tue, 31 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Boehringer Ingelheim and Eli Lilly and Company announced the FDA has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueta provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta (linagliptin) tablets. Tue, 31 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year VANISH-2, the first of two US Phase III studies comparing Varisolve (polidocanol endovenous microfilm) from BTG with placebo in patients with symptomatic and visible Varicose Veins and saphenofemoral junction incompetence. The trial met all primary, secondary and tertiary efficacy endpoints. Tue, 31 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA has approved Kalydeco(ivacaftor)from Vertex Pharma, the first medicine to treat the underlying cause of Cystic Fibrosis (CF), a rare, genetic disease. Kalydeco is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Approximately 1,200 people in the United States , or 4 percent of those with CF, are believed to have this mutation. The company has established a financial assistance and patient support program to help get Kalydeco to eligible patients for whom it is prescribed. Kalydeco was discovered as part of a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc. , the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation.Kalydeco is filed for approval in the EU. Tue, 31 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA has approved Tisseel [Fibrin Sealant] from Baxter to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical.TISSEEL mimics the final stages of the body’s own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis. Mon, 30 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA has accepted its New Drug Application (NDA) for standard review of bosutinib, a once a day oral dual Src and Abl kinase inhibitor from Pfizer, as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). This submission was based on efficacy and safety data from Study 200, a single-arm study of bosutinib in over 500 patients with previously treated Ph+ CML, including patients resistant or intolerant to imatinib as well as patients who were previously treated with dasatinib or nilotinib. Currently, there are no approved therapies available for CML patients after second-line treatment with dasatinib or nilotinib. see Study 200- ASH Accepted Abstract #892. Bosutinib as Third-Line Treatment for Chronic Phase Chronic Myeloid Leukemia Following Failure of Second-Line Therapy with Dasatinib or Nilotinib. Oral Presentation. H. J. Khoury - Presenter. 52nd American Society of Hematology Annual Meeting. Orlando, FL. December 4-7, 2010 Sun, 29 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Biogen Idec and Elan Corporation, have announced a global Phase IIIb study, ASCEND, that is being conducted to evaluate the effectiveness of Tysabri as a treatment for secondary-progressive multiple sclerosis (SPMS). According to the National Multiple Sclerosis Society, approximately half of all people initially diagnosed with relapsing-remitting Multiple Sclerosis (RRMS) - the most common form of Multiple Sclerosis (MS) - will transition to SPMS within 19 years. Patients with RRMS typically experience unpredictable relapses; the time between relapses is characterized by full or partial recovery and a lack of disease progression. SPMS is characterized by a steady progression of nerve damage, symptoms and disability, but the exact reasons for the progression are unknown. The potential for greater disease burden in SPMS typically includes decreased mobility, impaired activities of daily living, loss of independence and reduced quality of life. The primary endpoint is to investigate whether treatment with Tysabri slows the accumulation of disability not related to relapses in subjects with SPMS. Sun, 29 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA has approved Inlyta (axitinib)from Pfizer to treat patients with advanced kidney cancer (Renal Cell Carcinoma) who have not responded to another drug for this type of cancer. The decision was based on the AXIS 1032 study where axitinib significantly extended progression-free survival (PFS), with a median PFS of 6.7 months (95% CI, 6.3-8.6 months), compared with 4.7 months (4.6-5.6 months) for those treated with sorafenib a standard of care for this patient population. Recently approved drugs for the treatment of kidney cancer include Nexavar( sorafenib) (2005),Sutent (sunitinib) (2006),Torisel (temsirolimus )(2007), Afinitor (everolimus) (2009),Avastin (bevacizumab) (2009) and Votrient (pazopanib) (2009). Sat, 28 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Afatinib from Boehringer enters Phase III trials for Head and Neck cancer.LUX-Head & Neck 1 and LUX-Head & Neck 2. These trials evaluate Afatinib in patients with metastatic and recurrent head and neck cancer, and in patients with locally advanced disease, respectively. Sat, 28 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The OraQuick Advance Rapid HIV-112 Antibody Test, from OraSure, is comparable in accuracy to the traditional blood test, according to a new study. The meta-analysis, which compared studies worldwide, showed that the OraQuick test had the same accuracy as the blood test for high-risk populations. The test sensitivity was slightly reduced for low risk populations. The findings showed that the saliva test is 99 percent accurate for HIV in high risk populations, and about 97 percent in low risk populations. See: "Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis" by Nitika Pant Pai et al. The Lancet Infectious Diseases, Early Online Publication, 24 January 2012 doi:10.1016/S1473-3099(11)70368-1 Fri, 27 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Spectrum Pharmaceuticals will acquire from Bayer Healthcare the licensing rights to market Zevalin (ibritumomab tiuxetan) injection for intravenous use for the non-Hodgkin's lymphoma treatment outside the USA. Spectrum already has the rights to market the drug in the USA and will now hold the worldwide rights to Zevalin. The product is currently approved in more than 40 countries outside the US (covering Europe, Latin America and Asia) for the treatment of follicular B-cell non-Hodgkin's lymphoma. Bayer wish to move away from haematological oncology. Fri, 27 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The CHMP has issued a positive opinion for Remicade (infliximab) from Janssen Biologic for the treatment of severely active Ulcerative Colitis in paediatric patients aged between six to 17 who have had an inadequate response to conventional therapy, or who or intolerant to, or have medical contraindications to these therapies. The recommendation is based on a Phase III randomised, open-label trial in 60 children showing that the drug produced a clinical response in 73% of subjects by week eight, and maintained remission in up to 38% of responders by week 54. Remicade is approved for this indication in the USA and Canada. Thu, 26 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA has approved Picato (ingenol mebutate) gel in the 0.015%/0.05% strength from Leo Pharma for the topical treatment of Actinic Keratosis which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma. The drug is the first and only topical therapy available in the USA for Actinic Keratosis that can be used for as little as two or three days. Thu, 26 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Novartis reported the results of the 656 patient GRANITE-1 Phase III randomised, double-blind, multicentre study which showed that Afinitor (everolimus) monotherapy did not significantly improve overall survival in patients with advanced Gastric Cancer who had previously been treated with one or two lines of systemic chemotherapy. Thu, 26 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The European Commission has approved an extended indication for Rebif (interferon beta-1a) from Merck Serono, allowing its use in patients with early Multiple Sclerosis, in line with an earlier recommendation by the CHMP. It recommended that 44 micrograms of Rebif three times weekly should be given to patients who have experienced a single demyelinating event, an early sign of Multiple Sclerosis, and who are at high risk of developing the disease. Thu, 26 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Ipsen returns ROW rights to the adrenergic alpha-2 receptor antagonist fipamezole outside North America and Japan. Biovail ( now Valeant Pharma) returned the North American rights in 2010. Fipamezole is a first-in-class compound development for the treatment of levodopa-induced dyskinesia in Parkinson's disease and has completed Phase II trials. Santhera will seek other partners. Wed, 25 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Stage III Colon Cancer patients in the general population who receive adjuvant treatment for the disease have an improved rate of survival when Eloxatin (oxaliplatin) is added to 5-fluorouracil. It's known that adding Eloxatin to adjuvant 5FU improve outcomes of patients with stage III Colon Cancer in randomised clinical trials (RCTs) but the effect of this therapy outside RCTs is unknown. So researchers led by Hanna K. Sanoff, assistant professor of Medicine, Hematology and Oncology at the University of Virginia School of Medicine, gathered data from patients using the Surveillance, Epidemiology, and End Results registry linked to Medicare claims (SEER-Medicare), among other cancer registries. The researchers found that adding Eloxatin to adjuvant therapies for stage III Colon Cancer in patients of the general cancer population was just as effective as in patients from RCTs. The addition of Eloxatin showed improved survival across various practice settings, including those with older and minority patients as well as patients with greater comorbidity. See: "Comparative Effectiveness of Oxaliplatin vs Non–Oxaliplatin-containing Adjuvant Chemotherapy for Stage III Colon Cancer" by Hanna K. Sanoff et al. Journal of the National Cancer Institute, January 20, 2012 DOI:10.1093/jnci/djr524 Wed, 25 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The CHMP adopted a negative opinion, recommending the refusal of marketing authorisation for the medicinal product Folotyn,(pralatrexate injection), from Allos Therapeutics, intended for the treatment of peripheral T-cell Lymphoma. The CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not compared with any other treatment or placebo in another group of patients. Moreover, there was no clear improvement seen in the condition of the patients, as the study looked at the patients’ response to treatment but did not further allow the Committee to assess the effect on overall survival. The drug has Accelerated Approval in the USA. MundiPharma have the European rights. Wed, 25 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year NICE, the health technology appraisal body for England and Wales, has published final guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for preventing venous thromboembolism after knee and hip surgery. Eliquis will compete against Pradaxa from Boehringer abd Xarelto from Bayer HealthCare in this indication. No decision was made as to cost benefit comparisons. Wed, 25 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Baxter International Inc. will initiate a second Phase III trial to evaluate the use of its Gammagard Liquid 10% [Immune Globulin Infusion (Human)] (marketed as Kiovig outside the United States and Canada), for the treatment of mild to moderate Alzheimer's Disease. The company plans to initiate the new trial in the first quarter of 2012, having satisfactorily completed a futility analysis in its first Phase III trial known as the Gammaglobulin Alzheimer's Partnership (GAP) trial. After reviewing the futility analysis, the Data Safety Monitoring Board stated the ongoing GAP study could continue without modification. Baxter looks forward to seeing the final data in 2013 regarding the trial's endpoints, specifically whether Gammagard Liquid 10% will be a viable option for the treatment of this disease. Tue, 24 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year NovaBay Pharmaceuticals, Inc. is developing its first-in-class, anti-infective Aganocide compounds for the local non-systemic treatment and prevention of infections.The company has announced that it has selected multiple organizations to manage the Company's Phase IIb clinical study of NVC-422 for the treatment of Adenoviral Conjunctivitis, a form of "pink eye." This global study is anticipated to enroll up to 450 patients with confirmed Adenoviral Conjunctivitis at investigational sites in India, Brazil, and the United States. The drug is also in Phase II trials for Impetigo Tue, 24 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA has approved a product label change for Tysabri(natalizumab) from Biogen IDEC/Elan that will help enable individual benefit risk assessment for patients with relapsing remitting Multiple Sclerosis (MS).The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy(PML). Infection with the JC virus (JCV) is required for the development of PML and the new label states that anti-JCV antibody negative status indicates that exposure to the JC virus has not been detected. Patients who are anti-JCV antibody positive have a higher risk of developing PML. Patients who are anti-JCV antibody positive, have received prior immunosuppressant therapy and received treatment with Tysabri for more than two years have the highest risk of developing PML. The FDA also has allowed marketing of the first test, Stratify JCV Antibody ELISA test,from Focus Diagnostics, to help determine the risk for PML in people using Tysabri for Multiple Sclerosis or Crohn’s disease. Sun, 22 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The FDA recommends caution when prescribing drugs that treat Anaemia for patients with Chronic Kidney Disease (CKD) since the drug label's recommendations fall short. The recommendations apply to erythropoiesis-stimulating agents (ESAs) such as Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa). Trials show that ESAs can increase the risk of heart-related problems such as strokes and heart attacks when used to increase haemoglobin above 13 g/dL. The new ESA label states that clinicians should consider starting ESA treatment when haemoglobin levels fall below 10 g/dL, they should individualise dosing and use the lowest dose of ESA to reduce patients' need for blood transfusions. In addition, if a dialysis patient's haemoglobin level approaches or exceeds 11 g/dL, clinicians should reduce or hold the dose of ESA. Sun, 22 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Signifor (SOM230, pasireotide)from Novartis for the treatment of Cushing's Disease. There are currently no approved medicines in the European Union targeting Cushing's Disease, a debilitating endocrine disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumor.The CHMP positive opinion is based on data from the Phase III PASPORT-CUSHINGS trial, the largest randomized study to evaluate a medical therapy in patients with Cushing's Disease. see Colao, A. "Pasireotide (SOM230) provides clinical benefit in patients with Cushing's disease: results from a large, 12-month, randomized-dose, double-blind, Phase III study." Abstract# OC1.7. European Neuroendocrine Association (ENEA) 14th Congress. Sat, 21 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year The European Medicines Agency has received reports of unexplained deaths of patients taking Gilenya (fingolimod) the Multiple Sclerosis treatment from Novartis.The EMA has advised doctors to monitor patients new to the drug for six hours after first dosing as has the FDA. Six Gilenya patients have died of unknown causes, three of them suddenly. Another four died from cardiovascular problems that may or may not have been caused by the drug. Gilenya can slow patients' heart rates after the first dose. Novartis is co-operating with the regulatory authorities in the USA and EU. Sat, 21 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Ferrer has received approval to initiate Phase III clinical trials of ozenoxacin as a topical treatment for infectious dermatological conditions such as Impetigo. Ozenoxacin is a novel second generation non-fluorinated quinolone antibacterial agent. The first patients are expected to enter the trials in February 2012 and the studies are scheduled to complete in the first quarter, 2013. The multicentre clinical study comparing ozenoxacin one per cent cream versus placebo will be conducted in about 465 patients up to two years old with a clinical diagnosis of non-bullous or bullous Impetigo at approximately 50 centres in the USA, South Africa, Germany, Romania, India and the Ukraine, subject to completion of additional regulatory approvals. In addition to development in Impetigo and other dermatological conditions, ozenoxacin is being assessed for its potential to be developed in a variety of systemic indications, such as bone and joint infections and pulmonary infections. Sat, 21 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year http://www.epgonline.org/drug-news.cfm?by=Year Results of a Phase IIb/III placebo-controlled clinical trial of 4CMenB, from Novartis, in which 1631 adolescents received the vaccine, suggest that is is a safe and efficacious vaccine for protection against group B meningococcal disease. Immunogenicity was assessed as serum bactericidal activity using human complement (hSBA), an established immunological correlate of protection against meningococcal disease, for three of the antigens (and for one antigen by ELISA) using three defined reference strains of serogroup B N meningitis. After two doses of 4CMenB, 99–100% of recipients had hSBA titres of 4 or more, indicative of protection against the test strains that were chosen to assess the individual contributions of the vaccine. The vaccine developed to target strain B includes four components targeting various parts of the bacterium. No vaccine-related serious adverse events were reported and no significant safety signals were identified. This research team and others have now completed studies into efficacy of this vaccine for adults, children, and adolescents, all yielding similar, positive results. The research was led by Professors María Elena Santolaya and Miguel L O'Ryan, University of Chile and published in The Lancet (January 18, 2012 DOI:10.1016/ S0140- 6736(11)61713-3) titled: "Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study." Fri, 20 Jan 2012 00:00:00 GMT http://www.epgonline.org/drug-news.cfm?by=Year