News

FDA approves Kcentra (CSL Behring)to reverse vitamin K antagonist anticoagulation with major bleeding

The FDA on 29 April 2013 has approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions ...

EU approves Ilesto 7 (Biotronik) for patients with Heart Failure

The Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series, from Biotronik, has received CE approval in the EU for patients with Heart Failure who require resynchronisation therapy. The Ilesto 7 series includes one of the world’s smallest ICDs and features ProMRI technology, which enables access to potentially life-saving MR scans. The Ilesto offers patients and physicians the greatest longevity ...

Positive results from study of Symphony tCGM System (Echo Therapeutics) in critically ill patients

New results of needle-free Symphony Transdermal Continuous Glucose Monitoring (tCGM) System, from Echo Therapeutics, a non-invasive, wireless, transdermal continuous glucose monitoring system, collected from a clinical study of 15 critically ill patients over a 24 hour period at Tufts Medical Center in Boston, have been presented. Results show that using 570 Symphony tCGM glucose readings, paired with reference blood glucose ...

FDA approves octaplas LG (Octapharma) coagulation factor

The FDA has on 18 January 2013, approved octaplas,from Octapharma, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.

Octaplas has been used extensively in Europe and other countries. A previous generation of octaplas was ...

Aranesp (Amgen) fails Heart Failure trial

Amgen announced top-line results of the Phase III Aranesp (darbepoetin alfa) RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial. The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target ...

GSK/Theravance file GSK 573719 plus vilanterol at the EMA for COPD

GlaxoSmithKline and Theravance have announced the submission of a regulatory application to the EMA for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with Chronic Obstructive Pulmonary Disease (COPD).

UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK 573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2 agonist ,administered using ...

IQWiG finds no additional benefit in Eklira Genuair (Almiral) in COPD treatment

IQWiG reports in a preliminary review of data of Eklira Genuair/Bretaris Genuair (aclidinium bromide) from Almiral compared to Spiriva (tiotropium) offers no additional benefit to COPD patients.

IQWiG is the German review organisation that carries out assessments under AMNOG for the G-BA which has the final decision in Germany.Some studies were too short and others had shortcomings. According ...

Phase II study of RiaSTAP (CSL Behring) shows the drug has benefits in Critical Care patients

Clinical study results show that RiaSTAP (fibrinogen concentrate [human]), from CSL Behring, can significantly reduce the need for blood transfusion when given in a Critical Care situation, as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. The Phase II prospective study, led by Niels Rahe-Meyer of the Clinic for Anesthesiology and Intensive Care Medicine, at ...

GSK/Theravance file GSK 573719 plus vilanterol at the FDA for COPD

GlaxoSmithKline plc (GSK) and Theravance, Inc. have announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with Chronic Obstructive Pulmonary Disease (COPD).

UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK 573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a ...

EU awards CE mark to Revivent Myocardial Anchoring System (BioVentrix) for Heart Failure patients

BioVentrix has received the CE mark for its Revivent Myocardial Anchoring System, a surgical device that offers Heart Failure patients an alternative therapy to surgical ventricular restoration. The Revivent system is comprised of a series of titanium anchor pairs, each consisting of an internal anchor and an external anchor, which are introduced by transmural catheters. Once the desired number of ...

Early trial shows promising results with simvastatin in Wound Healing

An lab-based trial has found that topically applied generic statin simvastatin accelerates Wound Healing in diabetic mice, with important implications if the effect occurs in humans with Diabetes. The investigators treated wounds on mice with an application of either simvastatin in petroleum jelly or petroleum jelly alone. Treatment was repeated on days four, seven, and ten. After two weeks, the ...

RELAX-AF trial positive for serelaxin (Novartis) for Acute Heart Failure

RELAX-AF was a randomized, double-blind study involving 1,161 patients and was designed to compare the efficacy and safety profile of RLX030, from Novartis, to placebo in addition to standard therapy for the treatment of Acute Heart Failure (AHF). RLX 030 was given upon hospitalization in the form of an intravenous infusion (30 mcg per kg per day) for 48 ...

Positive results comparing programming of S-ICD and CRT-D defibrillators (Boston Scientific) in patients at risk of Cardiac Arrest

New results from the MADIT-RIT clinical trial demonstrated improved programming of Boston Scientific dual-chamber implantable cardioverter defibrillator (S-ICD) or cardiac resynchronization therapy defibrillator (CRT-D) heart devices can reduce inappropriate therapy and risk of death. MADIT-RIT is a prospective randomized three-arm trial comparing conventional programming with two alternative settings: a high-rate therapy arm and a duration-delay arm. It evaluated 1,500 primary ...

FDA and EU approve Sensation Plus (Maquet Cardiovascular) for patients with Heart Failure

Maquet Cardiovascular has received 510(k) clearance from the FDA and CE mark approval in the EU for its new Sensation Plus 40cc intra-aortic balloon (IAB) catheter. IAB therapy is used in patients with left ventricular failure and other cardiac conditions to augment coronary blood flow and to increase myocardial oxygen supply and decrease myocardial oxygen demand. This new larger-volume, fiber-optic ...

PT 003 (Pearl Therapeutics) success in Phase IIB study for COPD

Pearl Therapeutics Inc. has announced the completion of a randomized, double-blind, dose-ranging Phase IIb trial of PT003, Pearl's lead investigational inhaled combination bronchodilator product for the treatment of patients with moderate-to-severe COPD. This study assessed five BID doses of PT003, in which formoterol fumarate (FF) was co-formulated with five descending doses of glycopyrrolate (GP) and administered via metered-dose inhaler (MDI). ...

Novartis files QVA 149 in EU for COPD

QVA 149 (indacaterol plus glycopyrronium bromide), an investigational drug from Novartis, for Chronic Obstructive Pulmonary Disease (COPD) has been filed for marketing authorisation with the EMA. The first five studies in the Phase III IGNITE clinical trial program for QVA 149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 ...

NICE positive for Procoralan (Servier) for Heart Failure

The National Institute for Health and Clinical Excellence (NICE) has now published final draft guidance recommending Procoralan (ivabradine) from Servier Labs, as an option for treating Chronic Heart Failure, specified as NYHA class II to IVi. It has, however, stipulated that the drug should only be used in patients with systolic dysfunction, those who are in sinus rhythm, when ...

FDA approve S-ICD (Boston Scientific) for sudden Cardiac Arrest

The FDA had given approval for the S-ICD System (Boston Scientific), making it the first commercially available subcutaneous implantable defibrillator for the treatment of patients at risk for sudden Cardiac Arrest. FDA approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients ...

Breo(GSK/Theravance)combination filed at FDA for COPD

GSK and Theravance, Inc. announced that the New Drug Application (NDA) for the once-daily investigational medicine, Breo (US)/Relvar (EU) (fluticasone furoate “FF”/vilanterol “VI” (FF/VI)) for patients with Chronic Obstructive Pulmonary Disease (COPD), has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has ...

Phase III study results for serelaxin (Novartis) for Acute Heart Failure

Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with Acute Heart Failure (AHF). The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases. The study had two primary endpoints using different scales to measure reduction in ...

CPL 1001 (Sorbent Therapeutics) success in Phase II Heart Failure trial

There has been positive data from a randomized, double-blind Phase IIa clinical study of CLP 1001 from Sorbent Therapeutics. In the study of 111 Heart Failure patients with chronic kidney disease, CLP 1001 demonstrated improvement in Heart Failure symptoms as compared to placebo. CLP1001-treated patients achieved significantly greater weight loss – an accepted measurement of fluid retention – as compared ...

Phase II success for GSK 961081(GSK/Theravance) for COPD

GSK and Theravance announced positive data from a Phase II study of the dual acting muscarinic antagonist and beta 2 agonist (MABA) GSK 961081 as a treatment for moderate to severe COPD. The trial of 436 subjects showed clinically significant improvements to placebo for FEV1 trough on day 29, the primary endpoint....

Medtonic receives CE mark for Viva and Brava CRT-D devices for Heart Failure patients

Medtronic Inc has received CE Mark in Europe for its Viva and Brava Cardiac Resynchronization Therapy with Defibrillation (CRT-D) devices for treating patients with Heart Failure. The family of CRT-Ds features a new algorithm, called AdaptivCRT(R), which significantly improves heart failure patients' response rate to CRT-D therapy, as compared to historical CRT trials, by preserving the patients' normal heart rhythms ...

Positive interim results for Embrace Advanced Scar Therapy (Neodyne Biosciences)

An interim analysis demonstrates the efficacy of the Embrace Advanced Scar Therapy System from Neodyne Biosciences, within one of the most challenging scar-prone surgical procedures, an abdominoplasty (tummy tuck). The results of the first 28 patients to complete the six month assessment showed a highly significant difference between the expert blinded assessments of scar appearance for the Embrace treated ...

NICE recommends Procoralan (Servier) for treatment of Chronic Heart Failure

Procoralan (ivabradine) from Servier Labs has been recommended by NICE in draft guidance as a treatment option for people with Chronic Heart Failure. The treatment has been recommended in combination with standard therapy or when beta-blocker therapy is contraindicated or not tolerated, after impressing in clinical trials....

Trial of Symphony tCGM glucose monitoring in Critical Care

Echo Therapeutics, Inc. announced positive results from its clinical trial of the Symphony tCGM System in major general surgery and cardiothoracic surgery patients. This study is the second of two studies in critically ill patients. Data from this study demonstrate that Symphony successfully and continuously monitored glucose levels in the intensive care unit at Thomas Jefferson University Hospital in Philadelphia, ...

EC approves Eklira/Bretaris Genuair (Almirall/Menarini) for treatment of COPD

Almirall has announced that the European Commission has granted marketing approval to Eklira/Bretaris Genuair(aclidinium 322µg twice daily) in all EU member states, plus Iceland and Norway, as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Clinical efficacy studies showed that aclidinium provides around the clock significant and sustained bronchodilation ...

FDA approves Tudorza Pressair ( Forest Pharma) for COPD

The FDA on 23 July 2012 approved Tudorza Pressair (aclidinium bromide) from Forest Pharma for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ...

GSK/Theravance announce results of four Phase III studies of GSK 573719 plus vilanterol in COPD

GSK and Theravance announced results of four pivotal Phase III studies of GSK 573719 (umeclidunium bromide) ("UMEC"),a long acting muscarinic antagonist (LAMA) and vilanterol, a long acting beta agonist (LABA) ("VI") administered by dry powder inhaler for treatment of COPD.The results of the four pivotal phase III studies of UMEC/VI involved over 4,000 patients with chronic obstructive pulmonary disease (COPD). ...

FDA approves Verigene GP Blood Culture Nucleic Acid Test (Nanosphere) for identifying Bacterial Infections

The FDA has allowed marketing of the Verigene GP Blood Culture Nucleic Acid Test (BC-GP), from Nanosphere. This is the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of ...

CHMP recommends Seebri Breezhaler (Novartis) for COPD

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Seebri Breezhaler (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). Seebri Breezhaler is a long-acting muscarinic antagonist (LAMA), a type of ...

Abediterol (Almirall/Forest) superior to indacaterol in Phase IIa trial for COPD

In the Phase IIa, single-dose, study change from baseline in trough FEV1 following a single dose administration of a range of abediterol from Almirall/Forest Labs. doses below 10µg once daily, showed a statistically significant improvement versus placebo (p<0.001 for all abediterol doses) and, also, versus indacaterol 150µg (p<0.001 for abediterol doses of 2.5, 5 and 10µg. Abediterol once-daily in fixed ...

FDA approves revised labelling for Boston Scientific Defibrillators

The FDA has approved revised product labeling for the Boston Scientific Corporation Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices. The longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings. Projected ...

FDA accepts BLA for human 4-factor prothrombin complex concentrate (CSL Behring) for acute Bleeding

The FDA has accepted a Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC), from CSL Behring, for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major Bleeding. The submission is based on results from three prospective Phase III clinical trials that evaluated the safety and efficacy of PCC in patients who ...

CHMP recommends EU approval of Eklira (Almirall) for COPD

The EMA's CHMP has issued a positive opinion for the regulatory approval of Eklira (aclidinium), from Almirall, in all EU member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). As part of its assessment, CHMP reviewed efficacy and safety data of aclidinium BID from more than 2,500 patients. The clinical ...

Positive data from ADVANCE trial of Ventricular Assist Device (HeartWare) for Heart Failure patients

Updated results from the ADVANCE trial evaluating the use of the Ventricular Assist Device, from HeartWare, as a bridge to heart transplantation demonstrate the potential utility of the pump to improve treatment outcomes for end-stage Heart Failure patients. Success for the primary endpoint was judged by establishing non-inferiority between the HeartWare device and data derived from contemporaneous patients from the ...

BI 1744-CL (Boehringer) shows positive results in Phase II COPD trial

A Phase II study shows that BI 1744-CL (olodaterol), from Boehringer, provides a significant increase in the lung function parameter FEV1 over a 24-hour period for patients with COPD. It found BI 1744-CL (5 microgram QD) provided significant improvement in lung function as measured by FEV1 AUC(0-12) versus twice-daily BI 1744-CL (2 microgram), while twice-daily dosing of BI 1744-CL (5 ...

Seebri Breezhaler(Novartis) success in GLOW 2 study for COPD

Novartis and Vectura reported one-year data from the pivotal, Phase III GLOW 2 study, confirming that the inhaled long acting muscarinic receptor antagonist, NVA237 (glycopyrronium bromide), is superior to placebo and has similar efficacy to open-label tiotropium in the treatment of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)....

Seebri Breezhaler (Novartis) success in GLOW-3 trial for COPD

The GLOW 3 study investigated the effects of Seebri Breezhaler (NVA237), (glycopyrronium bromide) 50 mcg once-daily from Novartis on exercise endurance in moderate-to-severe COPD patients. The study met its primary endpoint by showing a significant 21% improvement in exercise endurance versus placebo at the end of the study (i.e. day 21), with a significant 10% increase from day one (both ...

IMDx GBS (IntelligentMDx) test system for Group B Streptococcus receives CE mark

The IMDx GBS for Abbott m2000, from IntelligentMDx, an automated, high-throughput, qualitative in vitro diagnostic test designed for the rapid detection of Group B Streptococcus (GBS) for use in screening pregnant women and those in labor who may be infected with the pathogen, has received CE mark approval. The system utilizes real time PCR, operates on the Abbott m2000 system ...

Lumax 740 defibrillator (Biotronik) is FDA approved

Biotronik has received FDA approval of its new Lumax 740 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds). Lumax 740 helps physicians monitor and treat their patients' arrhythmias and heart failure under ever-changing medical conditions. Lumax 740 is more informative to help manage a patient's heart failure progression; more specific to help reduce the chances of patients receiving ...

FDA approves Paradym defibrillators (Sorin) for patients at risk of Cardiac Arrest

The FDA has approved the Paradym RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices, from Sorin, for patients at risk of sudden Cardiac Arrest, including some whose heart failure can be managed by cardiac resynchronization therapy. These new heart devices, including the single-chamber Paradym RF VR, the dual-chamber Paradym RF DR and the Paradym RF ...

Lucassin (Ikaria) is approved for Hepatorenal Syndrome in Australia

Australian regulators have approved Lucassin (terlipressin) from Ikaria Australia for the treatment of Hepatorenal Syndrome type 1 (HRS 1) in patients who are actively being considered for a liver transplant, making it the first approved treatment for HRS 1. The product is already approved in France, Ireland, Spain and South Korea for this indication. In the US and Canada it ...

Phase III Study of QVA 149 (Novartis) for COPD meets primary endpoint and clarifies timing of US filings

New data on ILLUMINATE, a head-to-head Phase III study of QVA 149 (indacaterol plus glycopyrronium bromide), from Novartis, compared to Seretide(fluticasone plus salmeterol), shows the drug has met its primary endpoint in patients with moderate to severe Chronic Obstructive Pulmonary Disease. The ILLUMINATE study of more than 500 patients demonstrated that superior lung function (measured by FEV1 AUC0-12h with a ...

Ellipse Cardioverter Defibrillator ( St Jude) receives CE Mark

CE Mark approval has been granted for the Ellipse implantable cardioverter defibrillator (ICD)from st Jude Medical. Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD provides the benefits of advanced features and power in the industry's smallest high-energy Implantable Cardioverter Defribillator.Designed with feedback from more than 200 physicians from around the world, the Ellipse ...

First three Phase III studies positive for QVA 149 (Novartis)in COPD

The first three Novartis QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD.The results of SHINE, with an enrollment of more ...

Relovair (GSK/Theravance)programme is now complete for COPD and Asthma

Glaxo Smith Kline and Theravance, Inc. have announced that the registration programme for Relovair (fluticasone furoate plus vilanterol) is now complete. In addition, results from two studies for the once-daily Relovair (fluticasone furoate "FF"/vilanterol "VI" (FF/VI)) in patients with chronic obstructive pulmonary disease (COPD) and results from a study to evaluate the efficacy and safety of FF and FP (fluticasone ...

OptiScanner (OptiScan Biomedical) study shows clinical accuracy in monitoring blood glucose in Critically Ill ICU patients

New results demonstrate clinical accuracy for the OptiScanner, from OptiScan Biomedical Corp, in monitoring the blood glucose levels in critically ill ICU patients. Data presented from the MANAGE Study included results from a total of 63 critically ill medical and surgical ICU patients. Using Clarke Error Grid (CEG) analysis, 94.2 percent of the OptiScanner patient test results appeared in the ...

FDA approves Inomax (Ikaria Inc) for compatibility with 3 additional devices

The Center for Devices and Radiological Health (CDRH) branch of the FDA has granted 510(k) clearance for compatibility of the Inomax drug-delivery systems, from Ikaria Inc., with three additional respiratory care devices. The Inomax DS and the Inomax DSIR have now been validated with nearly 60 makes of ventilators, anesthesia systems and other respiratory care devices. The Inomax DS and ...

Positive results for Phase III study of Eklira/Bretairis (Almirall) for COPD

Full results of ATTAIN, a six month pivotal study of the efficacy and safety of Eklira/Bretairis (inhaled aclidinium), from Almirall, in patients with moderate to severe Chronic Obstructive Pulmonary Disease have been published in the European Respiratory Journal. Significant improvement from baseline was observed with aclidinium 200 microg and 400 microg versus placebo for trough FEV1 (99 and 128 mL; ...

Arcapta Neohaler (Novartis) is launched in USA for COPD

Novartis has launched its once-daily long-acting beta2 agonist Arcapta Neohaler (indacaterol inhalation powder) in the USA following its approval for chronic obstructive pulmonary disease by the FDA in July 2011. Indacaterol is already available in more than 30 countries following its first approval in the EU in November 2009 as Onbrez Breezhaler. The drug is approved in a total of ...

Purocin protein technology (AvidBiotics) offers rapid response to E.coli infection

A new study shows that AvidBiotics' antibacterial Purocin protein technology can be used to create a highly targeted bactericidal protein against the life-threatening foodborne E. coli O104 strain by making use of rapidly acquired, published, draft genomic sequence data. This strategy offers a rapid-response platform with the potential to create targeted agents for use against emerging bacterial pathogens within days-to-weeks ...

Patient enrollment complete for Phase III Dry Eye Study of SAR 1118 (SARcode)

Patient enrollment has been completed for the first pivotal Phase III clinical study (OPUS-1) of SAR 1118, from SARcode, for Dry Eye Disease. OPUS-1 is a randomized, double-masked study evaluating the safety and efficacy of SAR 1118 5.0% ophthalmic solution compared to placebo over a 12 week period. A total of 588 patients with Dry Eye Disease have been enrolled ...

FDA Advisory Committee recommends aclidium bromide(Forest/Almirall) for COPD

Forest Laboratories, Inc. and Almirall, S.A. announced that the FDA Pulmonary-Allergy Drugs Advisory Committee voted 12 to 2 in favor of approving the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of COPD. The Committee was also asked to separately evaluate if the efficacy and safety of the 400 ug twice daily dose ...

CHMP recommends Procoralan (Servier Labs) for Chronic Heart Failure

The CHMP has recommended Procoralan (ivabradine) from Servier Laboratories for Chronic Heart Failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is = 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated....

BTG licence of rights to Voraxaze for Methotrexate Toxicity

BTG has agreed to licence Ohara Pharmaceutical the rights in Japan to develop and market Voraxaze (glucarpidase) its treatment for Methotrexate Toxicity due to impaired renal function. The drug is filed in the USA and EU and its PDUFA action date is 17 January 2012....

BD MAX Assay (Becton, Dickinson and Company) for MRSA detection is EU approved

The BD MAX MRSA Assay, from BD Diagnostics, a Becton Dickinson company, for rapidly and accurately identifing methicllin-resistant Staphylococcus aureus (MRSA) in patients has received CE mark approval in the EU. The BD MAX is a fully automated, bench-top molecular system designed to perform a broad range of molecular testing. This offers the flexibility and versatility to perform CE/in vitro ...

FDA approves CFC-free Combivent Respimat Inhaler for COPD

The FDA has announced the approval of Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray for patients with Chronic Obstructive Pulmonary Disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. Combivent Respimat contains two different types of medicines that open airways in the lungs to help patients with ...

RESPeRATE device study shows benefits for Heart Failure patients

Results of a 72-patient controlled study of RESPeRATE, from InterCure, demonstrate that device–guided respiratory modulation with RESPeRATE applied at home can significantly relieve symptoms of Heart Failure in elderly patients. RESPeRATE is an FDA-cleared, CE-marked device indicated for the adjunctive treatment of hypertension for use as a relaxation aid by leading the user through interactively guided and monitored breathing exercises. ...

INTENSITY study of Onbrez Breezhaler and Spiriva in COPD reported in European Respiratory Journal

Results of the INTENSITY study ,being a comparison of Onbrez Breezhaler (indacaterol) from Novartis with Spiriva(tiotropium)from Boehringer/Pfizer were announced in November 2010. These results showed once-daily Onbrez Breezhaler was as effective as Spiriva in improving lung function in COPD patients. It also demonstrated that the indacaterol treatment provides "significantly greater clinical benefit in terms of reduced shortness of breath, lower ...

Daxas shows positive data on "Frequent exacerbations" in COPD

New findings from a post-hoc pooled analysis of two one-year studies of more than 1,500 roflumilast-treated patients with severe COPD, chronic bronchitis and a history of exacerbations show that Daxas (roflumilast) from Nycomed ,helps to prevent exacerbations in COPD patients of the 'frequent exacerbator' phenotype. The 'frequent exacerbator' group show worse health status and faster disease progression than those who ...

GLOW 1 and GLOW 3 studies to support SeebriBreezhaler application.

The GLOW 1 and GLOW 3 studies show that investigational NVA237 (glycopyrronium bromide)from Novartis significantly increased patients' lung function compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance. NVA237 is a new drug in the long-acting anti-muscarinic (LAMA) class which has recently been submitted for approval in the European Union under ...

EU Commission approves Dexdor for sedation of patients in Intensive Care

European Commission has granted Dexdor (dexmedetomidine) from Orion, centralised approval covering 27 European Union countries for sedation of adult intensive care unit patients requiring a level of sedation not deeper than arousal in response to verbal stimulation. The company plans to begin a European launch in Germany and Austria in early 2012. It will launch much later in other European ...

Combination Oladaterol and Tiotropium enters Phase III for COPD

Boehringer Ingelheim has initiated its Phase III trial that will investigate Spiriva (tiotropium) in combination with a new compound, olodaterol, a novel once-daily long-acting beta-2 agonist ,for the treatment of chronic obstructive pulmonary disease. Spiriva (tiotropium), a long-acting muscarinic antagonist (LAMA) co-marketed with Pfizer, is the most prescribed COPD drug worldwide, while olodaterol is a novel once-daily long-acting beta-2 agonist ...