MedicineNews.net - Medical Updates

uniQure will not seek marketing authorization renewal for Glybera in European Union

uniQure has announced that it will not pursue the renewal of the Glybera ( Alipogene tiparvovec ) marketing authorization in Europe when it is scheduled to expire on October 25, 2017. According to ... read article

Lung cancer: patients with responsive to Nivolumab, an immunotherapic drug, beat standard odds of survival

More than seven years after the start of one of the first clinical trials of the immunotherapy drug Nivolumab ( Opdivo ), researchers at the Johns Hopkins Kimmel Cancer Center have reported that the f ... read article

Regimen of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C GT1-6: FDA has granted priority review

The FDA ( U.S. Food and Drug Administration ) has accepted New Drug Application ( NDA ) and granted priority review for the investigational, pan-genotypic regimen of Glecaprevir and Pibrentasvir ( G/P ... read article

Chronic hepatitis C therapy: European Medicines Agency has granted accelerated assessment to Sofosbuvir, Velpatasvir, Voxilaprevir

Gilead Sciences has announced that the Marketing Authorization Application ( MAA ) for the investigational, once-daily, single tablet regimen of Sofosbuvir 400 mg, Velpatasvir 100 mg and Voxilaprevir ... read article

Oral Ozanimod, compared to Interferon beta-1a, reduces annualized relapse rate in patients with relapsing multiple sclerosis

The phase III SUNBEAM trial, evaluating the efficacy and safety of Ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis ( RMS ), m ... read article

Systemic lupus erithematosus: Benlysta wins backing from NICE

After previously rejecting the drug in 2011, NICE ( National Institute for Health and Care Excellence ) has approved lupus drug Benlysta ( Belimumab ) for limited use under a managed access scheme. ... read article

CHMP, positive opinion on Olumiant, an inhibitor of Janus kinase 1 and 2, for the treatment of rheumatoid arthritis

The Committee for Medicinal Products for Human Use ( CHMP ) of EMA ( European Medicines Agency ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicina ... read article

HyQvia, subcutaneous IG treatment for primary and certain secondary immunodeficiencies in adult and pediatric patients

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending marketing authorization for pediatric indication of HyQ ... read article

Development of MDCO-216, an investigational cholesterol efflux promoter, discontinued due to poor efficacy

Immediate discontinuation of the clinical development program for MDCO-216, an investigational cholesterol efflux promoter, was announced. Data from the MILANO-PILOT trial did not show drug effects ... read article

Glyxambi, a fixed-dose combination of Empagliflozin and Linagliptin, for the treatment of type 2 diabetes mellitus

The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Glyxambi, intended for the ... read article

Galafold in patients with Fabry disease, approved in European Union

The European Commission has granted approval for the oral small molecule pharmacological chaperone Galafold ( Migalastat ) as a first line therapy for long-term treatment of adults and adolescents age ... read article

Qtern, a fixed-dose of Saxagliptin and Dapagliflozin, for adults with type 2 diabetes mellitus: positive opinion from CHMP

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion, recommending the approval of Qtern ( Saxagliptin and Dapagliflozin ) ... read article

Ixekizumab clears psoriasis in clinical trials

About 80% of patients with moderate to severe psoriasis saw their disease completely or almost completely cleared with Ixekizumab ( Taltz ), according to three large, long-term clinical trials led by ... read article

FDA, second Breakthrough Therapy Designation for intranasal Esketamine: major depressive disorder with imminent risk for suicide

The FDA ( Food and Drug Administration ) has granted a Breakthrough Therapy Designation for Esketamine, an investigational antidepressant medication, for the indication of major depressive disorder wi ... read article

Sialanar for symptomatic treatment of severe sialorrhoea

The Committee for Medicinal Products for Human Use ( CHMP ), following a re-examination procedure, adopted a positive opinion for the medicinal product Sialanar, intended for the symptomatic treatment ... read article