MedicineNews.net - Medical Updates

Dovato as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection

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

COAST-X: Ixekizumab in patients with non-radiographic axial spondyloarthritis

Ixekizumab (Taltz ) has met the primary and all major secondary endpoints in COAST-X, a phase 3 study evaluating the safety and efficacy of Ixekizumab for the treatment of non-radiographic axial spond ... read article

Nonalcoholic steatohepatitis: combination of FXR agonist Cilofexor and ACC inhibitor Firsocostat

New data in nonalcoholic steatohepatitis ( NASH ) were presented at The International Liver Congress 2019 in Vienna. The data support the development of the combination therapies to target different ... read article

Long-term survival results from pooled analyses of Nivolumab in previously-treated non-small cell lung cancer patients

Results from pooled analyses of survival data from four studies ( CheckMate -017, -057, -063 and -003; n=664 ) in patients with previously-treated advanced non-small cell lung cancer ( NSCLC ) who wer ... read article

Kisqali plus Fulvestrant in women with HR+/HER2- locally advanced or metastatic breast cancer

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending an expanded indication for Kisqali ( Ribociclib ), the ... read article

Xofluza, a new drug to treat influenza approved by FDA

The U.S. Food and Drug Administration ( FDA ) has approved Xofluza ( Baloxavir marboxil ) for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptom ... read article

Lanreotide in patients with gastroenteropancreatic neuroendocrine tumors: effectiveness and patient satisfaction

An interim analysis of real-world outcomes collected from patients with gastroenteropancreatic neuroendocrine tumors ( GEP-NETs ) treated with Lanreotide ( Somatuline ) depot has demonstrated that tr ... read article

Nonalcoholic steatohepatitis: farnesoid X receptor agonists

Data from a phase 2 randomized, placebo-controlled trial of the investigational, selective, non-steroidal farnesoid X receptor ( FXR ) agonist GS-9674 were presented at The Liver Meeting 2018 in San F ... read article

Platinum-resistant / refractory ovarian cancer: Avelumab alone or in combination with pegylated liposomal Doxorubicin did not meet the primary endpoints of overall survival or progression-free survival

The phase III JAVELIN Ovarian 200 trial evaluating Avelumab ( Bavencio ) alone or in combination with pegylated liposomal Doxorubicin ( PLD ), a type of chemotherapy, compared with PLD did not meet th ... read article

Lurbinectedin has shown noteworthy clinical activity in metastatic breast cancer with mutations in BRCA 1/2

Lurbinectedin ( Zepsyre ) has shown noteworthy clinical activity in patients with metastatic breast cancer that have mutations in the BRCA 1 and/or BRCA 2 genes. A phase II trial has assessed the c ... read article

Tivozanib in combination with Nivolumab in renal cell carcinoma: interim results from phase 2 portion of the TiNivo trial

Updated interim results from the phase 2 portion of the TiNivo study, a phase 1b/2 multicenter trial of oral Tivozanib ( Fotivda ) in combination with intravenous Nivolumab ( Opdivo ), an immune check ... read article

Cosentyx label update in European Union to include dosing flexibility in psoriatic arthritis

The European Commission has approved a label update for Cosentyx ( Secukinumab ). Cosentyx is the first and only fully-human treatment that specifically inhibits interleukin-17A ( IL-17A ), in psoriat ... read article

Larotrectinib, a TRK inhibitor, in children and adults patients with NTRK fusion cancer

Larotrectinib is being investigated to potentially treat adult and pediatric patients with locally advanced or metastatic solid tumors with a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion ... read article

Tanezumab for the treatment of osteoarthritis pain

A 16-week phase 3 study in patients with osteoarthritis pain evaluating subcutaneous administration of Tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. ... read article

First two CAR-T cell medicines approved in the European Union: Kymriah and Yescarta

The European Commission ( EC ) has approved the first two marketing authorisations for chimeric antigen receptors ( CAR ) T-cells medicines in the European Union ( EU ). Kymriah ( Tisagenlecleucel ... read article