News

Trial shows Vascazen (Pivotal Therapeutics) effective in altering cholesterol levels in patients with CV Risk

A trial has demonstrated that Vascazen (omega-3 oil), from Pivotal Therapeutics, is highly effective in correcting an omega-3 deficiency. The company suggests this could have benefits for people at risk of developing CardioVascular Disease. In eight weeks of treatment a statistically significant (p<0.0001) increase of 121% in the Omega-Score and 112% (p<0.0001) in Omega-Index (the blood levels of EPA, DHA ...

Phase III trial shows FloraGlo lutein (OmniActive Health Technologies) fails to protect against AMD

A multicenter, randomized clinical trial that included people at high risk for progression to advanced Age-related Macular Degeneration (AMD), shows that adding lutein and zeaxanthin, and the omega-3 fatty acids DHA and EPA, as found in FloraGlo lutein from OmniActive Health Technologies, to a formulation of antioxidant vitamins and minerals (so-called AREDS formulation) that has shown effectiveness in reducing risk, ...

FDA approves Liptruzet (Merck Inc) for Dyslipidaemia

The FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets, from Merck Inc, for the treatment of Dyslipidaemia. It is indicated for elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Approval is based on results including a multicenter, clinical study in which 628 patients with hyperlipidemia ...

Study shows Ostinol (ZyCal Bioceuticals) improves pain and stiffness in Osteoarthritis

Results of the first double-blind, placebo-controlled study evaluating the benefits of Ostinol (cyplexinol), from ZyCal Bioceuticals, in alleviating symptoms of Osteoarthritis shows that this nutritional supplement decreases pain and stiffness, and offers an increase in quality of life as compared to placebo. Cyplexinol is a biologically active protein complex consisting of bone morphogenetic proteins which stimulate bone and cartilage growth ...

Study reveals mechanism providing benefit of omega-3 fatty acids on Cardiovascular health

A new study has uncovered a mechanism by which omega-3 fatty acids can benefit Cardiovascular health. Prof. Heinemann (Jena University), Prof. Dr. Michael Bauer (Jena University Hospital) and Prof. Dr. Toshinori Hoshi (University of Pennsylvania) have shown that the 'SLO1' potassium channel is an important component in the effectiveness of omega-3 fatty acids. These ionic channels act like very specific ...

Study suggests omega-3 fish oil can help protect against Skin Cancer

Researchers have carried out the first clinical trial to examine the impact of the fish oils on the skin immunity. Results of the study found that taking a regular dose of fish oils boosted skin immunity to sunlight. Specifically, it also reduced sunlight-induced suppression of the immune system, which affects the body’s ability to fight Skin Cancer and infection. Volunteers ...

FDA awards "Generally Recognized as Safe" status to Cardioviva (Micropharma) to help reduce bad cholesterol

The FDA have awarded heart health probiotic, Cardioviva (Lactobacillus reuteri NCIMB 30242), from Micropharma Ttd, with "Generally Recognized as Safe" (GRAS) status. This designation signifies that Cardioviva is considered safe by experts to use as an ingredient in food. Of the top 10 probiotic supplements in the US, Cardioviva is one of two to achieve FDA's GRAS approval.

The specific ...

Study shows prebiotic Bimuno (Clasado) shows some benefits to Gastrointestinal health

A randomized, placebo-controlled study of the prebiotic Bimuno, from Clasado, shows evidence of benefit in patients at risk of reduced Gastrointestinal health. A total of 45 overweight adults (body mass index > 25 kg/m2) with at least 3 risk factors for Metabolic Syndrome were followed for 28 weeks. During the first 12 weeks, volunteers were randomly assigned to consume either ...

Soluble Ferric Pyrophosphate (Rockwell Medical) success in Phase III trial for Iron Deficiency

Rockwell Medical announced successful topline results from the PRIME clinical study of Soluble Ferric Pyrophosphate (SFP), its investigational iron-delivery drug currently in Phase III clinical studies for the treatment of Iron Deficiency in hemodialysis patients. The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 37.1% while ...

Study of Qsymia (Vivus inc.) shows positive benefits for treatment of Obesity

A new study concludes that weight loss resulting from treatment with Qsymia (phentermine and topiramate extended-release), from Vivus inc., led to significant improvements in cholesterol, blood pressure and triglycerides in Obese and overweight patients. The improvements were significantly greater among patients who lost 10% or more of their starting weight. Participants in the study with body mass indexes of 27 ...

EU approves Optisharp (DSM Nutritional Products) for nutritional use

The European Commission approved the use of nature-identical Optisharp (zeaxanthin), from DSM Nutritional Products, as an ingredient in food supplements as a way to improve visual performance. The decision follows a positive EFSA safety assessment delivered on September 13, 2012, which concluded that the use level for zeaxanthin does not raise safety concerns. Studies have suggested that high concentration of ...

GI Dynamics initiates ENDO trial for treatment of Type 2 Diabetes and Obesity

GI Dynamics has initiated its U.S. multicenter pivotal clinical trial of EndoBarrier, the ENDO Trial, for the treatment of patients who have uncontrolled Type 2 Diabetes and are Obese.

EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In previous clinical studies, EndoBarrier has ...

Study finds CholestOff (Nature Made) reduces Cholesterol levels in patients with CV risk

A new study suggests CholestOff, a sterol/stanol ester-based softgel capsule, from Nature Made, offers benefits for decreasing LDL cholesterol in individuals with high Cholesterol levels. The randomized, placebo-controlled, crossover trial lasted 17 weeks during which all subjects followed a heart healthy diet (National Cholesterol Education Program TLC Diet). One group received a sterol/stanol softgel for 6 weeks while the other ...

Plecanatide (Synergy Pharma) success in Phase III trial for Constipation

Synergy Pharmaceuticals, Inc.has announced that plecanatide, its investigational oral drug for the treatment of Chronic Idiopathic Constipation (CIC), was well tolerated and met the primary and key secondary endpoints of a Phase IIb/III clinical study. Full study results will be presented at a major scientific meeting this year.

The randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study was designed to ...

Study shows benefits for bone growth in infants fed on InFat (Advanced Lipids)

A randomized, double-blind, controlled clinical trial on bone strength in term infants fed InFat, a high beta-palmitate formula, from Advanced Lipids, indicates InFat leads to significantly higher bone-strength parameters compared to a standard vegetable oil control. The trial studied the effect of 12 weeks feeding of infant formula with InFat on bone strength parameters. Bone strength results were measured by ...

New analysis explains competing findings in studies of omega-3 fatty acids and impact on CV Risk

A new analysis has sorted through many of the competing findings from studies of omega-3 fatty acids, and helps to explain why so many of the studies seem to arrive at differing conclusions.

The study, by scientists in the Linus Pauling Institute at Oregon State University and published in the Journal of Lipid Research, concludes that both fish consumption and ...

Study suggests probiotic Cardioviva (Micropharma) can help reduce bad cholesterol in blood

A new study suggests that a probiotic Cardioviva (lactobacillus reuteri), from Micropharma, can lower key cholesterol-bearing molecules in the blood as well as "bad" and total cholesterol in patients with high cholesterol. The study involved 127 adult patients with high cholesterol. About half the participants took L. reuteri NCIMB 30242 twice a day, while the rest were given placebo capsules. ...

CHMP rejects Qsiva (Vivus Inc.,) as a treatment for Obesity

On 18 October 2012, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Qsiva (phentermine plus topiramate) from Vivus Inc., intended for the treatment of Obesity.

The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine’s long-term effects on the ...

No significant evidence that cranberry juice can prevent UTIs

A Cochrane Library review finds that cranberries may not be effective in treating Urinary Tract Infections. Some evidence shows that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period, particularly for women with recurrent UTIs. However the addition of 14 further studies suggests that cranberry juice is less effective than previously indicated. Although some of ...

Lundbeck files vortioxetine at EMA for Major Depressive Episodes

Lundbeck A/S has announced the submission to the European Medicines Agency (EMA) of a marketing authorisation application (MAA) for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review. Vortioxetine belongs to a new generation of antidepressants that has been developed for the treatment of patients with major depressive episodes (MDE).The data ...

Positive results from study of pTeroPure (Glanbia) in patients with high cholesterol

New findings from a Phase II/III trial of pTeroPure (pterostilbene), from Glanbia, show this nutritional ingredient significantly reduced blood pressure in adults. The double-blind, placebo-controlled trial included 80 adults averaging 54 years of age with high cholesterol (total cholesterol of 200 or greater and/or LDL cholesterol of 100 or greater). Most participants were women (71%) and some had been diagnosed ...

No evidence for effect of omega-3 fatty acids on Cardiovascular Risk

In a study that included nearly 70,000 patients, supplementation with omega-3 polyunsaturated fatty acids was not associated with a lower risk of all-cause death, cardiac death, sudden death, heart attack, or stroke. Evangelos C. Rizos of the University Hospital of Ioannina, Ioannina, Greece, and colleagues performed a large-scale synthesis of the available randomized evidence by conducting a systematic review and ...

Evidence of benefit of Promitor (Tate & Lyle) for Nutritional Health

Two new research studies provide evidence that certain higher-fibre diets can in fact be well-tolerated, and that fibre may play an important role in supporting a healthy gut as well as promoting calcium absorption. In a crossover study, 23 adolescents 12-15 years old were given controlled diets over two, three-week sessions separated by a one-week washout period. The diets were ...

Positive results from DOLAB study for docosahexaenoic acid shows improvement in reading and behaviour in underperforming children

Results of the DHA Oxford Learning and Behaviour (DOLAB) study suggests that taking lifes DHA (docosahexaenoic acid), an omega-3 fatty acid, from Martek Biosciences, could be a simple and effective way to improve reading and behaviour in healthy but underperforming children. The researchers identified 362 healthy 7 to 9 year-olds attending primary schools and who had underperformed in standardized reading ...

Study finds link between chocolate consumption and Stroke risk

In a study based on a prospective investigation of a large group of male patients over 10 years, researchers have seen a link between chocolate consumption and stroke risk. The team looked at questionnaire responses from 37,103 Swedish men aged 49 to 75 and using data from the Swedish Hospital Discharge Registry, researchers identified 1,995 cases of first stroke among ...

Cocoa flavanols (Mars Symbioscience) may improve cognition according to Italian study

A study conducted by researchers from the University of L'Aquila in Italy and Mars Symbioscience provides evidence that the regular consumption of dietary cocoa flavanols may improve cognitive function in elderly subjects with early memory decline. Previous research has suggested that the benefits of cocoa flavanols could extend to the brain. However, these studies were either only short-term or did ...

FDA approves Qsymia (Vivus Inc.) treatment for Obesity

The FDA has approved Qsymia (phentermine and topiramate extended-release) formerly Qnexa from Vivus Inc., as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at ...

Phase III trial for Odanacitib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

Phase III trial for Odanacatib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee ...

FDA approves Belviq (Eisai/Arena Pharma) for Obesity

The FDA has approved Belviq (lorcaserin HCl), from Eisai and Arena Pharmaceuticals, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (Obese), or 27 kg/m2 or greater in the presence of at least one weight related comorbid condition. However the ...

Obesity drug Lorqess (Eisai) shows positive trial results

A new study on the effects of Lorqess (lorcaserin), from Eisai, for the treatment of Obesity shows positive results. The study, titled BLOOM-DM, evaluated 604 obese and overweight participants with Type 2 Diabetes in a double-blind placebo-controlled randomized trial over a one-year treatment period. Although all participants received systematic lifestyle change counseling, those on the medication lost 4.5 – 5.0% ...

Cranberry juice and Urinary Tract Infections study

A new study from Jeffrey Blumberg at Tufts University evaluated the cranberry’s role in promoting urinary tract health through compounds known as proanthocyanidins (PACs). The study confirmed the presence of unmetabolized PACs in the urinary tract after consumption, adding some evidence to ex-vivo research that suggests potential benefits of the compounds found in cranberry juice. In addition, a pilot study ...

NOP 47 significant impact on Vascular Endothelial function

Whey protein intake reduces CVD risk, but little is known whether whey-derived bioactive peptides regulate vascular endothelial function (VEF). Researchers determined the impact of a whey-derived extract (NOP-47) from Glanbia Nutrition on VEF in individuals with an increased cardiovascular risk profile. Men and women with impaired brachial artery flow-mediated dilation (FMD) (n 21, age 55 (sem 1·3) years, BMI 27·8 ...

Omega 3 fatty acids cellular processes are mapped.

US based scientists have mapped the cellular processes that power the heath effects of Omega 3 fatty acids by studying living mouse cells and finding that the beneficial fatty acids block an enzyme known as cyclooxygenase (COX) which produces the prostaglandin hormones that spark inflammation. This is the first comprehensive study of what fish oils actually do inside a cell. ...

Lu AA 21004 successful Phase III trials in Depression

Lundbeck announced positive top-line results from three recently completed phase III clinical studies of Lu AA21004, an investigational drug for the treatment of adults with major depressive disorder (MDD) using dosages from 10 to 20mg. The positive results from these three studies showed that Lu AA21004 statistically significantly reduced depression symptoms in patients with MDD compared to placebo as measured ...

FDA Advisory Comittee recommends Lorqess (Arena/Eisai)for weight loss

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended approval for Lorqess(lorcaserin) as a prescription weight-loss medicine in an 18-4 vote with one abstention. The Committee considered that the available data demonstrated the potential benefits of weight loss with lorcaserin outweigh its possible risks of valvular heart disease, adverse cardiovascular events or malignancies when used long-term in a population ...

Positive study of probiotics (Danone) for Antibiotic Associated Diarrhoea

A study from Susan Hempel of RAND Health, Santa Monica, Calif., and researchers shows that eating probiotic foods such as yogurt, reduces the risk of antibiotic-associated diarrhoea, a prevalent side effect of antibiotic use. The team searched databases in order to identify randomized controlled trials (RCTs) involving probiotic use (Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, and/or Bacillus) for the prevention or ...

Neurostar TMS therapy (Neuronetics) success in Depression

Patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving NeuroStar TMS Therapy from Neuronetics achieved significant improvements in both depression symptoms and in quality of life measurements. Overall, 58 percent of patients achieved a positive response to NeuroStar TMS therapy, with 37 percent of patients achieving remission from their depression. After an average of five weeks of NeuroStar treatment, the ...

First human study of Anatabloc (Star Scientific) for Alzheimer's Disease

Star Scientific and its subsidiary Rock Creek Pharmaceuticals have received IRB approval for the first human clinical study of the safety and effects of nutritional supplementation with Anatabloc in individuals with Alzheimer's disease. Anatabloc contains 1 milligram of anatabine base, 500 units of Vitamin A and 40 units of Vitamin D3. Anatabine is a natural alkaloid found in Solanaceous plants ...

Phase II study of Vyvanse (Shire) for Binge Eating Disorder

A study to evaluate the safety and efficacy of Vyvanse(lisdexamfetamine dimesylate) Capsules 30, 50 or 70 mg compared to placebo in adults with Binge Eating Disorder at Week 11 as measured by the number of binge days per week as assessed by clinical interview based on patient diary. A binge day was defined as a day during which at least ...

UP 446 botanical extract (Unigen) reduces pain scores in Osteoarthritis

In a randomised, double blind, placebo study, 60 people aged between 45 and 75 years were given, in the first group, placebo,in the second and third groups given 250 mg and 500mg per day of the botanical extract UP 446 from Unigen and in the fourth group were given 200 mg per day of celecoxib for 90 days. Results showed ...

CHMP recommends Rienso (Takeda) for Iron Deficiency Anaemia

)The CHMP has recommended marketing authorisation for Rienso, 30 /ml, solution for injection from Takeda, being the intravenous treatment of Iron Deficiency Anaemia in adult atients with Chronic Kidney Disease. The active substance of Rienso is ferumoxytol, a colloidal iron-carbohydrate complex. Upon release from the complex, the iron either enters the intracellular storage iron pool (e.g., ferritin) or is transferred ...

FDA approves i-Lipo (Chromogenex) for Fat Reduction therapy

The FDA has cleared the i-Lipo low-level laser diode device, from Chromogenex, to market for circumferential reduction or Fat Reduction. The clearance is based on results from a double-blind, placebo-controlled, randomized study of 34 volunteers in which over 70% of participants experienced significant waist reduction. Of the 34 participants, 19 were randomly selected for the treatment group and 15 for ...

Meta analysis supports use of soy isoflavones to allieviate hot flushes

A new meta-analysis on the effects of soy isoflavones in the alleviation of menopausal hot flashes was published March 19 by Menopause: The Journal of The North American Menopause Society and found clear and consistent evidence that soy isoflavone supplements, like NovaSoy brand soy isoflavones from Archer Daniels Midland Company, are significantly more effective than placebo in reducing the frequency ...

CDP7851/AMG 785 (UCB/Amgen) enters Phase III for Osteoporosis

UCB and Amgen have announced the start of their sclerostin antibody (CDP7851/AMG 785) Phase III clinical trial program for the treatment of Post Menopausal Osteoporosis. The Phase III program includes a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 ...

US court rules that Seroquel XR patent (AstraZeneca) is valid

A US court has ruled that the formulation patent for the extended-release version of the antipsychotic Seroquel XR is valid and has been been infringed by generics companies. The district court in New Jersey has found the formulation patent protecting Seroquel XR (quetiapine fumarate) extended-release tablets to be valid and ruled that four firms - Anchen Pharmaceuticals, Osmotica Pharmaceutical Corp, ...

FDA approves Omontys(Affymax/Takeda)for anaemia for patients on Dialysis

The FDA has approved Omontys (peginesatide) from Affymax Inc.,/Takeda to treat Anaemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce ...

Dr Reddy has FDA approval for generic Seroquel.

The US patent covering instant-release Seroquel (quetiapine) from AstraZeneca expired on March 26 .Dr Reddy Laboratories announces that the FDA has approved an Abbreviated New Drug Application for its 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg versions. Sun Pharmaceutical Industries and Lupin have also received FDA approval to launch their generics in the US ...

Teva Pharma launches generic Seroquel and Seroquel XL

Teva Pharma UK has launched generic versions of Seroquel and Seroquel XL as Quetiapine and Quetiapine XL.Other generic versions are likely from Accord Pharma, Intas Pharma, Hexal and Sandoz. A 25 mg coated tablet of Seroquel costs $40.50 compared to $6.08 for the generic....

Gastro-AD soy supplement launched

Lallemand Health Ingredients presents Gastro-AD, a food supplement based on non-GMO soy fermented by proprietary Lactobacillus strain L. delbrueckii R-187, with excellent track-record of safe and effective use for gastric comfort and the relief of occasional heartburn, backed by several published studies. Gastro-AD represents a 100% natural and safe alternative to heartburn products management with the extra nutritional benefits and ...

S-equol supplement (PharmaVite) success in lipids trial

A 12-week treatment of the fermented soy germ-based nutritional supplement containing S-equol from PharmaVite significantly lowered hemoglobin A1c (HbA1c), LDL cholesterol and improved vascular stiffness, all factors that occur as part of Metabolic Syndrome, according to a first-of-its-kind peer-reviewed study reported in a poster at the Women's Health 2012 annual meeting....

Results show Protelos (Servier) slows progression of Osteoarthritis

New results of a Phase III study show that Protelos (strontium ranelate), from Servier, show the drug has beneficial effects for Osteoarthritis as well as offering beneficial effects on pain, function, and mobility. In the study, 1,683 patients with knee Osteoarthritis received either Protelos 2g/day, 1g/day or placebo. The primary endpoint was the measurement of narrowing of the medial-tibio femoral ...

UK court rules AstraZeneca's patent on Seroquel XR is invalid

The UK High Court has ruled that AstraZeneca's patent on the extended-release version of Seroquel XR (quetiapine fumarate) is invalid. The patent had been challenged by Accord Healthcare, Intas Pharmaceuticals, Novartis' Hexal and Sandoz generics units and Teva. The UK ruling is the first that says the patent is invalid, in contrast to the decision in March by the District ...

FDA approves generic Bonviva (Roche)

The FDA has approved the first generic versions of Boniva (ibandronic acid), from Roche, a once-monthly product to treat or prevent Osteoporosis in women after menopause. The manufacturers that have gained FDA approval for generic 150 milligram tablets are Apotex, Orchid Healthcare, and Mylan. The once-monthly Bonviva branded 150 mg tablet was originally approved by the FDA in March 2005....

AstraZeneca discontinues development of TC 5214 for Major Depreeive Disorder

AstraZeneca has ceased development of its nicotinic channel blocker TC 5214 for which it had collaborated with Targacept as an adjunctive treatment in depression patients who did not respond to initial treatment. In RENAISSANCE 4 and 5 trials TC 5214 did not meet its primary endpoint....

Protelos(Servier) indication for Osteoporosis to be updated by EMA

The EMA still views Protelos/Osseor (strontium ranelate) from Servier Labs as an "important treatment" for women with Osteoporosis and its benefit: risk profile remains favourable, but it is no longer to be recommended for certain patients,and warnings on serious skin reaction will be updated. Prescribers should no longer prescribe the treatment to patients with current venous thromboembolism (VTE) or a ...

First Patient Treated in Phase III Study of RiaSTAP (CSL Behring) to Control Bleeding in Aortic Aneurysm Surgery

The first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of RiaSTAP (fibrinogen concentrate (Human)), from CSL Behring, in controlling microvascular bleeding during Aortic Aneurysm Surgery. The purpose of this study is to demonstrate that FCH can reduce intraoperative bleeding and, therefore, the volume of donor blood products (e.g., fresh ...

Glaucoma drug BOL-303259-X (Bausch & Lomb) meets endpoints in Phase IIb Study

The Phase IIb study conducted with BOL-303259-X, a novel nitric oxide-donating prostaglandin F2-alpha analog from Bausch & Lomb, in patients with open-angle Glaucoma or Ocular Hypertension, met its primary efficacy endpoint and showed positive results on a number of secondary endpoints. The primary efficacy endpoint was the reduction in mean diurnal intraocular pressure (IOP) on day 28. Two of the ...

Zemplar (Abbott) shows positive results in Phase IV Hyperparathyroidism study

A Phase IV clinical trial comparing the efficacy of Zemplar, from Abbott, against cinacalcet plus low-dose vitamin D in treating secondary Hyperparathyroidism (SHPT) in patients on kidney dialysis (hemodialysis) shows that more patients treated with intravenous Zemplar achieved their treatment goal, compared to patients treated with cinacalcet plus low-dose vitamin D. The study, IMPACT-SHPT, was an international, multi-centre investigation of ...

Omega-3 fatty acids study and brain aging

Trial data published in Neurology from 1500 dementia-free participants who underwent MRI scanning suggested that diet levels in omega-3 fatty acids could cause the brain to age faster and lose memory and thought abilities. Regular consumption of foods rich in omega-3 fatty acids can slow mental decline. People with DHA in the lowest quartile of the partipants had lower brain ...

Successful Phase III trial for levomilnacipran ( Pierre Fabre/Forest Labs) in Major Depressive Disorder

Positive top-line results in a Phase III trial showed that treatment with levomilnacipran (F 2695) from Pierre Fabre/Forest Labs. significantly reduced depression symptoms in patients with Major Depressive Disorder compared to placebo, as early as week one.This is the second, positive Phase III study in this population and results from an additional late-stage fixed-dose study are expected in the spring. ...

Surfaxin (Discovery Labs) is FDA approved for Respiratory Distress Syndrome

The FDA has approved Surfaxin (lucinactant) from Discovery Laboratories for the prevention of Respiratory Distress Syndrome (RDS), a breathing disorder that affects premature infants.The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has ...

FDA refuses to approve lipid-lowering combination of atorvastatin and ezetimibe (Merck)

The FDA has issued a Complete Response Letter regarding Merck's new drug application ezetimibe and atorvastatin tablets, an investigational combination medicine for Dyslipidaemia. In the letter, the agency advised Merck that it has completed its review of the submission and stated that additional data are needed. Merck plans to discuss next steps with the agency in the near future, including ...

EMA accepts MAA for Hematide (Takeda) for Anaemic adults on dialysis

The EMA has accepted Hematide (peginesatide), from Takeda, for assessment for a Marketing Authorisation Application (MAA) for the treatment of symptomatic Anaemia associated with Chronic Kidney Disease (CKD) in adult patients on dialysis. The submission was supported mainly by data from two Phase III studies (EMERALD 1 and 2) that evaluated the drug's efficacy and safety, dosed once every four ...

Lactobacillus reuteri Protectis (BioGaia) reduced Diarrhoea in children

A placebo-controlled study showed that nutritional supplementation of Lactobacillus reuteri Protectis, from BioGaia, reduced episodes of Diarrhoea. Lactobacillus reuteri Protectis was particularly effective in children with lower nutritional status. Another probiotic strain, which was also tested, was without effect. The six month long study was performed in Indonesia and included 494 healthy children aged one to six years. The children ...

FDA Advisory Committee recommends Qnexa(Vivus Inc.) for treatment of Obesity

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 20-2 that the benefits of Qnexa (phentermine/topiramate) from Vivus Inc.,outweigh the risks in the treatment of Obesity. The committee recommended that Vivus should conduct a post-marketing study with regards to the potential cardiovascular side effects of Qnexa. The company has also proposed a risk evaluation and mitigation strategy which includes ...

FDA Advisory Committee recommends Qnexa(Vivus Inc.) for treatment of Obesity

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 20-2 that the benefits of Qnexa (phentermine/topiramate) from Vivus Inc.,outweigh the risks in the treatment of Obesity. The committee recommended that Vivus should conduct a post-marketing study with regards to the potential cardiovascular side effects of Qnexa. The company has also proposed a risk evaluation and mitigation strategy which includes ...

RP-G28 success in Phase II trial fro lactose Intolerance

Ritter Pharma announced results of a Phase II trial for which showed RP-G28 improved digestive symptoms associated with Lactose Intolerance, including abdominal pain, and also reduced breath hydrogen production (a commonly used diagnostic test for lactose maldigestion). An abstract summarising the results is being presented orally at the annual international Digestive Disease Week (DDW) 2012 meeting in San Diego, California ...

New FDA drug labels for anaemia associated with Chronic Kidney Disease patients treated with ESAs

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 ...

European decentralised approval concluded for Steovess (Takeda) for Osteoporosis

Takeda Pharmaceuticals International GmbH announced that the European decentralised procedure was positively concluded for Steovess (formerly known as EX101), a once-a-week 70mg buffered effervescent alendronate for the treatment of Post-menopausal Osteoporosis. The Company submitted its application for marketing authorization in multiple countries through the DCP on 17 September 2010, with the United Kingdom (MHRA) serving as its Reference Member State ...

TC 5214 fails second Phase III trial for Major Depressive Disorder

AstraZeneca announced that the second RENAISSANCE Phase III study of TC-5214 for patients with Major Depressive Disorder did not meet its primary end point. The target measure was change in the Montgomery-Asberg Depression Rating Scale total score after eight weeks of treatment with TC-5214 as compared to placebo. TC-5214 was overall well tolerated in RENAISSANCE 2 and showed an adverse ...

FDA advisers vote in favour of Hematide (Takeda/Affymax) approval for Anaemia

The FDA's Oncologic Drugs Advisory Committee has voted 15 to 1 that Hematide (peginesatide), from Takeda and Affymax, demonstrate a favorable benefit/risk profile for use in the treatment of dialysis patients with Anaemia due to chronic kidney disease (CKD). While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA ...

Injectafer/Ferinject (Vifor/Luitpold) meets endpoints in two trials for Iron Replacement

Two large, multi-center, randomised, controlled clinical trials of Injectafer (US brand name of Ferinject, ferric carboxymaltose) from Vifor Pharma/Luitpold Pharma,were presented at the American Society of Nephrology’s (ASN) Kidney Week 2011.The first trial, poster FR-PO1394, compared Injectafer to oral iron or i.v.iron and the sevond trial, poster LB-PO3155, compared Injectafer to Venofer. Both trials met their efficacy and safety endpoints. ...

SMC 021 fails Phase III trial for Post Menopausal Osteoporosis

SMC 021, an oral salmon calctonin from Novartis, failed to meet main fracture reduction endpoints in Study 2303 a study of Post Menopausal Osteoporosis and to demonstrate a significant difference between treatment groups at three years for the primary endpoint of reducing new vertebral fractures. Similarly no statistical significant response was observed on key secondary endpoints such as new non-vertebral ...

TC 5214 fails first Phase III trial for Major Depressive Disorder

Phase III results of TC 5214, a nicotinic channel blocker from AstraZeneca/Targacept, were disappointing in the first study (RENAISSANCE 3) of four studies as an adjunct therapy to an antidepressant in patients with major depressive disorder who do not respond adequately to initial treatment. The study did not meet its primary endpoint of change on the commonly-used Montgomery-Asberg Depression Rating ...

Qnexa (Vivus Inc) Phase III results published in Obesity

Phase III data for Qnexa ((phentermine plus topiramate) from Vivus Inc., of the 56-week EQUIP study have been published in Obesity, the peer-reviewed journal of The Obesity Society. The trial evaluated the efficacy and safety of Qnexa in 1,267 severely obese (BMI >/= 35 kg/m2) patients in the USA. In addition to an average weight loss of 14.4% of initial ...

Numeta (Baxter) launched in EU for I.V. Nutrition

Baxter International Inc.,announced today the European launch of Numeta (emulsion for infusion) as the first and only triple-chamber system with formulations specifically designed to meet the range of intravenous (IV) nutritional requirements of neonatal and pediatric patients (preterm newborns through age 18). This premix therapy addresses an important unmet medical need to support neonatal and pediatric patients' changing daily nutritional ...

Novartis cancels development of Valdoxan in the USA

Novartis has cancelled development of agomelatine (AGO178) in major depressive disorder in the USA. The drug is known as Valdoxan in the rest of the world where it originated with and is marketed by Servier Laboratories which had ,in 2006, licensed the USA rights to Novartis....

Vivus re-submiots Qnexa to the FDA for Obesity treatment

Vivus has resubmitted its new drug application to the FDA for its obesity treatment Qnexa (phentermine/topiramate), for a narrower patient population, which would include overweight men and women of non-childbearing potential. Vivus expects a final FDA decision in the second quarter of 2012. The question of potential birth defects associated with topiramate is being met with a new trial called ...

Afssaps refers Protelos to EMA for re-evaluation as a treatment for Post Menopausal Osteoporosis

The French regulatory agency Afssaps has decided not to suspend Protelos (strontium ranelate),the Post Menopausal Osteoporosis drug from Servier Labs. Afssaps has referred the drug to EMA and asked for a re-evaluation. There are safety concerns due to cases of venous thrombo-embolism in patients over 80 years of age (who have additional risk factors) and cases of DRESS (dry rash ...

FDA agrees with Orexigen the form of CV risk trial for Contrave

The FDA had requested a cardiovascular outcomes trial (CVOT) for Contrave (naltrexone HCl/bupropion)which Orexigen had rejected. After a meeting with the FDA the form of the CVOT has been agreed. The trial will take two years to complete and will be conducted with obese patients who have CV risk. Submission to the FDA can be made on the basis of ...

FDA agrees form of CV risk trial for Contrave

The FDA had requested a cardiovascular outcomes trial (CVOT) for Contrave (naltrexone HCl/bupropion)which the company had rejected. After a meeting with the FDA the form of the CVOT has been agreed. The trial will take two years to complete and will be conducted with obese patients who have CV risk. Submission to the FDA can be made on the basis ...

Ostora oral calcitonin safe and effective for Osteoporosis

The Phase III ORACAL trial evaluating Ostora tablets (calcitonin oral), from Tarsa Therapeutics, for the treatment of postmenopausal Osteoporosis, has yielded positive safety and efficacy results, according to data presented at the American Society for Bone and Mineral Research 2011 Annual Meeting. The trial compared Tarsa's oral recombinant salmon calcitonin to placebo and to commercially available, synthetic salmon calcitonin administered ...

SHOTZ study shows Forteo more effective than Zometa in bone remodelling

Data from the SHOTZ study were compared showing the mechanisms of action of Forteo (teriparatide [rDNA origin] injection) from Eli Lilly and zoledronic acid (Zometa) from Novartis that evaluated histomorphometric measurements of bone remodeling in transiliac crest bone biopsies from postmenopausal women with osteoporosis. These data were presented in an oral presentation at the 2011 Annual Meeting of the American ...

Protelos risk benefit profile in PMO questioned

The transparency committee at the French health authority, HASe has been investigating pharmacoviligence data on Protelos( strontium ranelate) from Servier to see if its risk benefit profile needs to change. The drug has been associated with hyperesenitivity reactions such as rash, eosinophilia , systemic syndromes (DRESS)(16 cases) and Stevens Johnson Syndrome. EMA was critical of the Servier pharmacovigilence system and ...

Qnexa to be re-filed at FDA for Obesity

Vivus will resubmit its application to the FDA for Qnexa (phentermine plus topiramate), by the end of October,which is about two months before top-line results are expected from the firm's retrospective observational study assessing fetal outcomes in the offspring of women exposed to topiramate(forming part of Qnexa) during the first trimester of pregnancy. Results of the study are expected by ...

Affymax and Takeda submit NDA for Hematide

Affymax Inc. and Takeda Pharmaceutical Company Limited announced the submission of a New Drug Application (NDA) to the FDA for the investigational agent peginesatide (formerly known as Hematide) for the treatment of anemia associated with chronic renal failure (CRF) in adult patients on dialysis. The NDA includes data from two Phase III studies (EMERALD 1 and 2) that evaluated the ...

Hematide analyse of EMERALD studies

Affymax, Inc. and Takeda Pharmaceutical Company Limited announced results of additional analyses from two Phase III studies (EMERALD 1 and 2) of the investigational agent, peginesatide (formerly known as Hematide) in chronic renal failure (CRF) patients on dialysis with anemia.The EMERALD studies, showed that once-monthly peginesatide was comparable to epoetin given up to 13 times a month in maintaining hemoglobin ...