MedicineNews.net - Medical Updates

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

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