Xarelto approved for treatment of pulmonary embolism and prevention of recurrent deep vein thrombosis and pulmonary embolism in the European Union

European Commission ( EC ) has approved oral anticoagulant Xarelto ( Rivaroxaban ) for the treatment of pulmonary embolism ( ...

Leggi articolo

Canagliflozin as add-on therapy to Metformin and Pioglitazone significantly lowers blood sugar levels in adult patients with type 2 diabetes

Janssen has announced that the investigational agent Canagliflozin substantially lowers blood glucose levels compared to placebo when used as add-on ...

Leggi articolo

CANVAS trial: Canagliflozin as add-on therapy to Insulin lowers blood sugar levels in patients with type 2 diabetes at an elevated risk for cardiovascular disease

Janssen has announced that use of the investigational agent Canagliflozin substantially has lowered blood glucose levels when used as add-on ...

Leggi articolo

SGLT2 inhibitors: Forxiga approved in European Union for treatment of type 2 diabetes

Bristol-Myers Squibb and AstraZeneca have announced that the European Commission has approved Forxiga ( Dapagliflozin ) tablets for the treatment ...

Leggi articolo

Xeljanz for rheumatoid arthritis, approved by FDA

The FDA ( Food and Drug Administration ) has approved Xeljanz ( Tofacitinib ) to treat adults with moderately to ...

Leggi articolo

Anticlotting drugs: Xarelto approved by FDA to treat, reduce recurrence of blood clots

The FDA ( Food and Drug Administration ) has expanded the approved use of Xarelto ( Rivaroxaban ) to include ...

Leggi articolo

Pradaxa: genetic determinants of plasma levels and their relation to clinical response

Fixed-dose unmonitored treatment with Dabigatran etexilate ( Pradaxa ) is effective and has a favorable safety profile in prevention of ...

Leggi articolo

Advanced or metastatic soft tissue sarcoma: Doxorubicin remains the gold standard in the first line chemotherapy

The EORTC 62012 trial attempted to resolve controversy regarding whether Ifosfamide ( Holoxan ) had been previously tested at too ...

Leggi articolo

Prolia for the treatment of bone loss in men with osteoporosis at high risk for fracture

La Food and Drug Administration ( FDA ) has approved a new indication for Prolia ( Denosumab ) as a ...

Leggi articolo

Stivarga for treatment of metastatic colorectal cancer approved by FDA

Bayer HealthCare has announced that the Food and Drug Administration ( FDA ) approved Stivarga ( Regorafenib ) tablets for ...

Leggi articolo

Parkinson’s disease: Pramipexole and possible risk of heart failure

The FDA ( Food and Drug Administration ) has informed the public about a possible increased risk of heart failure ...

Leggi articolo

Apremilast: clinical benefit in psoriatic arthritis

Celgene has announced that statistical significance for the primary endpoint of ACR20 at week 16 was achieved for patients receiving ...

Leggi articolo

Secondary prophylaxis in adults with severe hemophilia A: Kogenate is effective in reducing bleeding frequency

Bayer HealthCare has announced that Kogenate ( Octocog alfa ) is effective and well tolerated at reducing bleeding frequency in ...

Leggi articolo

TRILOGY-ACS trial: Prasugrel versus Clopidodrel for patients with unstable angina or NSTEMI who are medically managed without revascularization

The first trial to study the effect of platelet inhibition in patients with acute coronary syndromes managed medically without revascularisation ...

Leggi articolo

Lixisenatide in combination with basal Insulin plus oral antidiabetics significantly reduces HbA1c and post-prandial glucose

Sanofi has announced data demonstrating Lyxumia ( Lixisenatide ), a once-daily investigational GLP-1 agonist, in combination with basal Insulin plus ...

Leggi articolo

Type 2 diabetes: in patients who have had a previous myocardial infarction the most beneficial agents are Metformin and Gliclazide

New research has suggested that several commonly prescribed drugs for type 2 diabetes may not be as effective at preventing ...

Leggi articolo

Acetaminophen in prescription combination products: FDA strategy caps maximum at 325 milligrams to reduce risk of liver toxicity

The FDA ( Food and Drug Administration ) has asked manufacturers of prescription combination products that contain Acetaminophen ( Paracetamol ...

Leggi articolo

European Commission: approval for Kalydeco, the first medicine to treat the underlying cause of cystic fibrosis in people with G551D mutation

Vertex Pharmaceuticals has announced that the European Commission has approved Kalydeco ( Ivacaftor ) for patients with cystic fibrosis ages ...

Leggi articolo

Rivaroxaban, a new treatment for blood clots approved by NICE

Patients with blood clots can be now be offered Rivaroxaban ( Xarelto ) as an alternative to Warfarin ( Coumadin ...

Leggi articolo

Truvada, the first drug for reducing the risk of sexually acquired HIV infection: FDA approved

The FDA ( Food and Drug Administration ) approved Truvada ( Emtricitabine / Tenofovir disoproxil fumarate ), the first drug ...

Leggi articolo

FDA has approved Myrbetriq for overactive bladder

The FDA ( Food and Drug Administration ) has approved Myrbetriq ( Mirabegron ) to treat adults with overactive bladder, ...

Leggi articolo

FDA: QT prolongation with Ondansetron

The FDA ( Food and Drug Administration ) has informed healthcare professionals and the public that preliminary results from a ...

Leggi articolo

Second-line drug for type 2 diabetes mellitus: Linagliptin results in less hypoglycaemia, less weight gain and perhaps less cardiovascular risk

A new drug could offer significant advantages over existing treatments for type 2 diabetes mellitus patients who don’t respond to ...

Leggi articolo

FDA has approved Daliresp, a drug to treat chronic obstructive pulmonary disease

The FDA ( Food and Drug Administration ) has approved Roflumilast ( Daliresp ), a pill taken daily to decrease ...

Leggi articolo

FDA: Azithromycin and the risk of cardiovascular death

The FDA ( Food and Drug Administration ) is aware of the study published in the New England Journal of ...

Leggi articolo

FDA: available data do not support an association between the use of Spiriva HandiHaler and an increased risk of stroke, heart attack, or death from a cardiovascular cause

Early Communications issued in 2008 by the FD ( Food and Drug Administration ) described a potential increase in the ...

Leggi articolo

Vedolizumab in patients with moderately to severely active Crohn's disease: improvement in clinical remission in induction and maintenance phases

Takeda Pharmaceutical has announced top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal phase 3 trial. The trial ...

Leggi articolo

Eplerenone reduces atrial fibrillation in patients with mild heart failure

The aldosterone antagonist Eplerenone ( Inspra ) has significantly reduced the development of new onset atrial fibrillation and flutter in ...

Leggi articolo

Selective serotonin reuptake inhibitors increase risks for elderly

Older people taking new generation antidepressants are at more risk of dying or suffering from a range of serious health ...

Leggi articolo

Interventions for impetigo, a superficial bacterial skin infection

Impetigo is a common, superficial bacterial skin infection, which is most frequently encountered in children. There is no generally agreed ...

Leggi articolo

Interferon-beta for secondary progressive multiple sclerosis

Therapy with either recombinant beta-1a or beta-1b interferons ( IFNs ) is approved for relapsing remitting multiple sclerosis ( RRMS ...

Leggi articolo

Anti-angiogenesis treatments: Bevacizumab, Sunitinib increase breast cancer stem cells

Cancer treatments designed to block the growth of blood vessels were found to increase the number of cancer stem cells ...

Leggi articolo

Expanded label on Berinert for self-administration and treatment of acute laryngeal attacks of hereditary angioedema, FDA approved

The FDA ( Food and Drug Administration ) has approved a label expansion for self-administration of Berinert, C1 Esterase Inhibitor ...

Leggi articolo

Duodart, a fixed dose combination medicine for benign prostatic hyperplasia

GlaxoSmithKline ( GSK ) has announced that Duodart, a fixed dose combination of Dutasteride ( 0.5mg ), and Tamsulosin ( ...

Leggi articolo

Smoking-cessation drugs: Varenicline unsuitable for first-line use

The poor safety profile of the smoking-cessation drug Varenicline ( Chantix, Champix ) makes it unsuitable for first-line use, according ...

Leggi articolo

Avastin for the treatment of women with newly diagnosed, advanced ovarian cancer, EU approved

Roche has informed that the European Commission has approved Avastin ( Bevacizumab ) in combination with standard chemotherapy ( Carboplatin ...

Leggi articolo

Ampyra improves walking in adults with multiple sclerosis, FDA approved

The FDA ( Food and Drug Administration ) has approved Ampyra ( Dalfampridine ) extended release tablets to improve ...

Leggi articolo

Multaq linked to increased risk of death or serious cardiovascular events

The FDA ( Food and Drug Administration ) has completed a safety review of Multaq ( Dronedarone ). This review ...

Leggi articolo

Xarelto approved in the European Union for the prevention of stroke in patients with atrial fibrillation and in the treatment of deep vein thrombosis

Oral anticoagulant Xarelto ( Rivaroxaban ) has been approved by the European Commission ( EU ) for use in two ...

Leggi articolo

Lantus associated with an increased risk for breast cancer

Having diabetes or being obese after age 60 significantly increases the risk for developing breast cancer, a Swedish study has ...

Leggi articolo

End stage renal disease: Digoxin linked to mortality

Digoxin has been used for decades for the treatment of cardiovascular disease ( CVD ). In 1997, the FDA ( ...

Leggi articolo

Adults with type 2 diabetes: Saxagliptin when added to Insulin maintains reductions in glycosylated hemoglobin levels over 52 weeks

Results from an investigational hhase 3b clinical study have shown that the addition of Saxagliptin ( Onglyza ) 5 mg ...

Leggi articolo

No link between intracerebral hemorrhage and statin use among patients with prior stroke

Among patients who have had an ischemic stroke, use of cholesterol-lowering statin medications is not associated with subsequent intracerebral hemorrhage. After ...

Leggi articolo

Transthyretin familial amyloid polyneuropathy: Vyndaqel, first therapy approved in the European Union

European Commission has approved Vyndaqel ( Tafamidis ) for the treatment of transthyretin familial amyloid polyneuropathy ( TTR-FAP ) in ...

Leggi articolo

Eylea injection for the treatment of wet age-related macular degeneration

The FDA ( Food and Drug Administration ) has approved Eylea ( Aflibercept ) injection, known in the scientific literature ...

Leggi articolo

Ibuprofen may lower risk of Parkinson's disease

New research suggests that Ibuprofen ( Brufen ) may offer protection against developing Parkinson's disease. The study is published in ...

Leggi articolo

FDA has approved Potiga to treat seizures associated with epilepsy in adults

The FDA ( Food and Drug Administration ) has approved Potiga ( Ezogabine ) for use as an add-on medication ...

Leggi articolo

Type 2 diabetes patients inadequately controlled with Metformin: safety and efficacy of Dapagliflozin plus Metformin at 102 weeks

Bristol-Myers Squibb ( BMS ) and AstraZeneca have announced results from an exploratory 78-week study extension of a phase 3 ...

Leggi articolo

Onfi as add-on therapy for seizures associated with Lennox-Gastaut syndrome, FDA approved

The FDA ( Food and Drug Administration ) has approved Onfi tablets ( Clobazam ) for use as an adjunctive ...

Leggi articolo

Somatropin: possible increased risk of death

FDA ( Food and Drug Administration ) has informed the public that results from a study conducted in France ( ...

Leggi articolo

Eteplirsen has demonstrated generation of greater than 50% dystrophin-positive muscle fibers in a patient following systemic administration in Duchenne muscular dystrophy

AVI BioPharma has announced biopsy data from Study 28, the ongoing phase 1b/2 clinical trial of AVI-4658 ( Eteplirsen ), ...

Leggi articolo

Sprycel linked to risk of pulmonary arterial hypertension

The FDA ( Food and Drug Administration ) has informed the public that the leukemia drug Sprycel ( Dasatinib ) ...

Leggi articolo

FDA has approved Juvisync, a fixed-dose combination of Sitagliptin and Simvastatin

The FDA ( Food and Drug Administration ) has approved Juvisync ( Sitagliptin and Simvastatin ), a fixed-dose combination prescription ...

Leggi articolo

FDA has approved Cialis to treat benign prostatic hyperplasia

The FDA ( Food and Drug Administration ) has approved Cialis ( Tadalafil ) to treat the signs and symptoms ...

Leggi articolo

Possible increased risk of blood clots with contraceptives containing Drospirenone

FDA ( Food and Drug Administration ) has reviewed six published epidemiologic studies that evaluated the risk of venous thromboembolism ...

Leggi articolo

Zometa does not reduce the recurrences of breast cancer

A trial investigating the use of Zoledronic acid ( Zoledronate; Zometa ) to aid chemotherapy for breast cancer has not ...

Leggi articolo

Osteoporosis: Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment

Reclast ( Zoledronic Acid, Zoledronate; Europe: Aclasta ) is used to: a) treat or prevent osteoporosis in women after menopause. ...

Leggi articolo

Lorcaserin causes significant weight loss and improves maintenance of weight loss

The results from the two-year BLOOM ( Behavioral modification and Lorcaserin for Overweight and Obesity Management ) trial have been ...

Leggi articolo

Benefit of Ezetimibe is not proven in patients with elevated cholesterol levels

Elevated blood cholesterol levels are regarded as a risk factor for heart attacks and other cardiovascular diseases. However, this does ...

Leggi articolo

Xgeva for preventing cancer-related bone injury, FDA approved

The FDA ( Food and Drug Administration ) has approved Xgeva ( Denosumab ) to help prevent skeletal-related events ( ...

Leggi articolo

Zytiga for metastatic castration-resistant prostate cancer, approved in the European Union

The European Commission ( EC ) has approved the marketing authorisation for Zytiga ( Abiraterone acetate ), a novel, once-daily, ...

Leggi articolo

Safety concerns associated with DPP-4 inhibitors

There were several adverse events of special interests, including hypoglycemia, hypersensitivity reactions, renal and hepatic events, severe cutaneous adverse reactions, ...

Leggi articolo

Europe: Linagliptin for treatment of diabetes mellitus type 2 approved

Boehringer Ingelheim and Eli Lilly have received marketing authorization from the European Commission for Linagliptin 5 mg film-coated tablets ( ...

Leggi articolo

FDA has approved Firazyr for acute attacks of hereditary angioedema

The FDA ( Food and Drug Administration ) has granted marketing approval for Firazyr ( Icatibant injection ) for treatment ...

Leggi articolo

Pegloticase for severe, chronic gout associated with improvement in symptoms

As an alternative to a conventional treatment for gout that some patients may not respond to, patients with severe, chronic ...

Leggi articolo

Dalcetrapib: safety profile and potential for slowing of plaque progression in patients at risk of coronary heart disease

Roche has announced results from two exploratory mechanistic Phase IIb studies investigating Dalcetrapib’s effects on atherosclerotic disease progression ( dal-PLAQUE ...

Leggi articolo

Heart rate reduction with Ivabradine reduces clinical events in heart failure

A high heart rate is an independent risk factor for chronic heart failure ( HF ) patients and lowering the ...

Leggi articolo

ATOLL trial: IV Enoxaparin more effective than unfractionated Heparin in reducing PCI complications

Enoxaparin ( Clexane, Lovenox ), a low molecular weight Heparin, is more effective in reducing serious ischaemic events than the ...

Leggi articolo

Use of long-term, high-dose Fluconazole during pregnancy may be linked to birth defects in infants

The FDA ( Food and Drug Administration ) has informed the public that chronic, high doses ( 400-800 mg/day ) ...

Leggi articolo

FDA: Afinitor approved for subependymal giant cell astrocytoma associated with tuberous sclerosis

The FDA ( Food and Drug Administration ) has granted accelerated approval to Everolimus ( Afinitor ), an mTOR inhibitor, ...

Leggi articolo

Cubicin: risk of eosinophilic pneumonia

There have been rare but potentially serious reports of eosinophilic pneumonia associated with Daptomycin ( Cubicin ). If eosinophilic pneumonia ...

Leggi articolo

Multaq: risk of cardiac failure and risk of hepatotoxicity

The use of Dronedarone may be associated with: a) an elevated risk of worsening, or new-onset, heart failure; b) liver ...

Leggi articolo

Risk of cardiac failure when Insulin is combined with Pioglitazone

Cases of cardiac failure have been reported when Pioglitazone was used in combination with Insulin, especially in patients with risk ...

Leggi articolo

Recombinant human growth hormone: increased risk of death is inconclusive

The FDA ( Food and Drug Administration ) has determined that, at this time, the evidence regarding recombinant human growth ...

Leggi articolo

Risk of osteonecrosis of the jaw associated with Bevacizumab and Sunitinib

Treatment with Bevacizumab or Sunitinib may be a risk factor for the development of osteonecrosis of the jaw, particularly if ...

Leggi articolo

Ticagrelor for patients with acute coronary syndromes

New research has shown that the stronger anticlotting medication Ticagrelor ( Brilinta, Brilique ) reduces death rates without increasing bleeding ...

Leggi articolo

Oral osteoporosis drugs: bisphosphonates and potential increased risk of esophageal cancer

The FDA ( Food and Drug Administration ) is continuing to review data from published studies to evaluate whether use ...

Leggi articolo

Alemtuzumab reduces relapse rate by 55% compared to Interferon beta-1a in treatment-naïve multiple sclerosis patients

Sanofi and its subsidiary Genzyme have announced results from CARE-MS I, the first of two randomized, Phase 3 clinical trials ...

Leggi articolo

Anti-inflammatory drugs linked to risk of atrial fibrillation or flutter

Non-selective non-steroidal anti-inflammatory drugs ( NSAIDs ) and selective COX-2 inhibitors are linked to an increased risk of atrial fibrillation ...

Leggi articolo

Smoking cessation: Champix is associated with a 72% increased risk of a serious adverse cardiovascular events

Heart disease is a common cause of serious illness and death in smokers and is often a reason for people ...

Leggi articolo

Valproate: risk of impaired cognitive development in children exposed in utero

The FDA ( Food and Drug Administration ) has notified healthcare professionals that children born to mothers who take the ...

Leggi articolo

NIH stops AIM-HIGH trial on Niacin: lack of efficacy in reducing cardiovascular events

The National Heart, Lung, and Blood Institute ( NHLBI ) of the National Institutes of Health ( NIH ) has ...

Leggi articolo

Medullary thyroid cancer: FDA has approved Vandetanib

The FDA ( Food and Drug Administration ) has approved Vandetanib ( Zactima ) to treat adult patients with metastatic ...

Leggi articolo

Systemic juvenile idiopathic arthritis: FDA has approved Actemra in children ages 2 years and older

The FDA ( Food and Drug Administration ) has approved Actemra ( Tocilizumab ), given alone or in combination with ...

Leggi articolo

Diabetes mellitus type 2: FDA has approved Tradjenta

The FDA ( Food and Drug Administration ) has approved Tradjenta ( Linagliptin ) tablets, used with diet and exercise, ...

Leggi articolo

Mexiletine for treating symptom of muscular dystrophy

A medication most often used to treat heart arrhythmias also reduces a central symptom of myotonic dystrophy, the most common ...

Leggi articolo

Nevirapine may be beneficial for some HIV-infected children who have achieved viral suppression

HIV-infected children in South Africa who were exposed to the drug Nevirapine ( Viramune ) at birth ( used to ...

Leggi articolo

Trastuzumab-DM1 as a first-line therapy in HER2+ metastatic breast cancer

A new type of breast cancer treatment has shown encouraging activity as a first-line therapy in HER2-positive metastatic disease. Edith Perez, ...

Leggi articolo

Bipolar disorder type 1: Abilify approved for maintenance treatment as an adjunct to either Lithium or Valproate ( 2011 )

The FDA ( Food and Drug Administration ) has approved Abilify ( Aripiprazole ) as an adjunct to the mood ...

Leggi articolo

Postmenopausal osteoporotic women: Lasofoxifene reduces breast cancer risk

Lasofoxifene ( Fablyn ) statistically reduced the overall risk of breast cancer, as well as ER positive invasive breast cancer ...

Leggi articolo

Breast cancer - Tamoxifen: risk of reduced therapeutic response in patients who are poor CYP2D6 metabolisers or use medicines inhibiting CYP2D6

Tamoxifen is extensively broken down in the body through the process of metabolism to form several intermediate products known as ...

Leggi articolo

Belimumab: safety findings

The safety database for Belimumab ( Benlysta ) is based primarily on the three randomized, placebo-controlled studies ( L02, C1056, ...

Leggi articolo

Zoledronic acid added to standard adjuvant therapy does not show disease free survival advantage compared to standard therapy alone

Results from the second interim analysis of the Phase III AZURE ( Adjuvant Zoledronic acid to redUce Recurrence ) trial ...

Leggi articolo

Aromatase inhibitors appear to increase the risk of cardiac events among women with breast cancer

The purpose of a study was to determine differences in serious adverse events associated with aromatase inhibitors compared with Tamoxifen ...

Leggi articolo

SAGhE study: increased risk of death in patients treated with recombinant human growth hormone during childhood

The long-term epidemiological study called SAGhE ( Santé Adulte GH Enfant ) was designed to assess the long-term mortality of ...

Leggi articolo

DASISION study: results from the 18-month follow up comparing Dasatinib to Imatinib in first-line treatment of adults with Ph+ chronic phase chronic myeloid leukemia

Results from the 18-month follow up of the Phase 3 DASISION study of Dasatinib ( Sprycel ) 100 mg once ...

Leggi articolo

Apixaban in acute coronary syndrome: APPRAISE-2 trial discontinued

Bristol-Myers Squibb and Pfizer have discontinued the Phase 3 APPRAISE-2 clinical trial in patients with recent acute coronary syndrome ( ...

Leggi articolo

Phase 2 interim data have shown high objective response rate for patients treated with Elotuzumab plus Lenalidomide and low-dose Dexamethasone

Interim results from the Phase 2 portion of a Phase 1b/2 open-label study have shown a high objective response rate ...

Leggi articolo

Krystexxa for the treatment of chronic gout in adult patients refractory to conventional therapy

The FDA ( Food and Drug Administration ) has approved Krystexxa ( Pegloticase ), a PEGylated uric acid specific enzyme ...

Leggi articolo

Oral Laquinimod for multiple sclerosis: initial results from ALLEGRO study

Teva Pharmaceutical and Active Biotech have announced initial results from the two-year Phase III ALLEGRO study, which demonstrated that relapsing-remitting ...

Leggi articolo

• ← Precedente
• Successivo →