Xagena.net - Update in Medicine

European CHMP adopts positive opinion for Vosevi, a single tablet regimen of Sofosbuvir, Velpatasvir, Voxilaprevir, for the treatment of all chronic hepatitis C genotypes

The Committee for Medicinal Products for Human Use ( CHMP ), the scientific committee of the European Medicines Agency ( EMA ), has adopted a positive opinion on Vosevi, an investigational, once-dail ... read article

Tagrisso receives full approval in the EU for patients with locally-advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer

The European Commission ( EC ) has granted full marketing authorisation for Tagrisso ( Osimertinib ) 40mg and 80mg once-daily tablets for the treatment of adult patients with locally-advanced or metas ... read article

Atezolizumab in people with previously treated advanced bladder cancer: IMvigor211 study did not meet its primary endpoint of overall survival compared to chemotherapy

The phase III IMvigor211 study, that evaluated Atezolizumab ( Tecentriq ) in people with locally advanced or metastatic urothelial cancer ( mUC ) whose disease progressed during or after treatment wit ... read article

Locally advanced or metastatic urothelial carcinoma: Imfinzi in patients with disease progression during or following Platinum-containing chemotherapy

The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Durvalumab ( Imfinzi ) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have ... read article

FDA: increased risk of serious pancreatitis with irritable bowel drug Viberzi in patients without a gallbladder

The FDA ( U.S. Food and Drug Administration ) is warning that Viberzi ( Eluxadoline ), a medicine used to treat irritable bowel syndrome with diarrhea ( IBS-D ), should not be used in patients who do ... read article

Ocrevus, the first drug for primary progressive multiple sclerosis approved by FDA

The FDA ( U.S. Food and Drug Administration ) has approved Ocrevus ( Ocrelizumab ) to treat adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis ( PPMS ... read article

CDK4/6 inhibitors: Kisqali in combination with an aromatase inhibitor as treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer

The U.S. Food and Drug Administration ( FDA ) has approved Kisqali ( Ribociclib ), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therap ... read article

Positive CHMP opinion for Tafinlar in combination with Mekinist in BRAF-positive non-small cell lung cancer patients

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Tafinlar ( Dabrafenib ) in combination with ... read article

Evolocumab has significantly reduced the risk of cardiovascular events in FOURIER Outcomes Study

The FOURIER trial to evaluate whether Evolocumab ( Repatha ) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease ( ASCVD ) met its prim ... read article

COMPASS trial: Rivaroxaban in patients with coronary or peripheral artery disease has shown overwhelming efficacy and has met primary endpoint early

The phase III trial COMPASS evaluating the efficacy and safety of Rivaroxaban ( Xarelto ) for the prevention of major adverse cardiac events ( MACE ) including cardiovascular death, myocardial infarct ... read article

Afstyla is the first and only single-chain therapy for haemophilia A, approved by European Commission

The European Commission has granted marketing authorisation for Afstyla [ recombinant human coagulation Factor VIII, single chain ] for children and adults with haemophilia A. Afstyla is the first a ... read article

Lucentis to treat patients for visual impairment due to choroidal neovascularization associated with causes other than neovascular age-related macular degeneration or secondary to pathologic myopia, EC approved

The European Commission ( EC ) has granted an additional indication for Lucentis ( Ranibizumab ) to treat patients with visual impairment due to choroidal neovascularization ( CNV ) associated with ca ... read article

Cimaglermin, a novel investigational drug, may help restore cardiac function after heart failure

Cimaglermin, a new experimental drug, may help restore cardiac function after heart failure, according to a first-in-man study published in JACC: Basic to Translational Science. Heart failure, char ... read article

Keytruda for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations, recommended by CHMP for approval

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of Keytruda ( Pembrolizumab ), an anti-PD-1 th ... read article

Ibrance, a CDK 4/6 inhibitor, has received approval in European Union for the treatment of women with HR+/HER2- metastatic breast cancer

The European Commission ( EC ) has approved Ibrance ( Palbociclib ) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative ( HR+/HER2- ) locally a ... read article