MedicineNews.net - Medical Updates

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

Truberzi, first-in-class medication offering sustained relief from multiple symptoms of irritable bowel syndrome with diarrhoea

The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for Truberzi ( Eluxadoline ) in the European Union. Truberzi is an oral medication that relieves the main ... read article

Keytruda in recurrent or metastatic head and neck cancer, FDA granted priority review

The FDA ( Food and Drug Administration ) has accepted for review the supplemental Biologics License Application ( sBLA ) for Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the treatment of pati ... read article

Advanced melanoma: a combination of two immunotherapeutic agents, Opdivo and Yervoy, has received positive CHMP opinion

The Committee for Medicinal Products for Human Use ( CHMP ) of the EMA ( European Medicines Agency ) has recommended the approval of Opdivo ( Nivolumab ) in combination with Yervoy ( Ipilimumab ) for ... read article

Advanced melanoma: Pembrolizumab, an immunoinhibitory checkpoint protein

Pembrolizumab ( Keytruda ) is a humanized monoclonal antibody against programmed death receptor-1 ( PD-1 ), a key immunoinhibitory checkpoint protein implicated in down-regulating anti-tumour immune r ... read article

CHMP positive opinion for Viekirax plus Exviera without Ribavirin for the treatment of HCV in GT1B patients with compensated cirrhosis

The European Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has granted a positive opinion for the use of Viekirax ( Ombitasvir / Paritaprevir / Riton ... read article