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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

SOLAR-1 trial: alpha-specific PI3K inhibitor Alpelisib has met primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation

The global phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor Alpelisib ( BYL719 ) has met the primary endpoint showing an improvement in progression-free survival ( ... read article

TRANSITION trial: Entresto can be safely initiated shortly after an acute heart failure episode

Data from the TRANSITION study presented at the European Society of Cardiology ( ESC ) Congress in Munich, Germany, have shown that Entresto ( Sacubitril / Valsartan ) can be initiated early and safel ... read article

Focus

Multiple sclerosis: FDA has approved Tecfidera

The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with relapsing forms of multiple sclerosis.Multiple sclerosis is a chronic, inflammatory, ... read article

Apremilast linked to significant and clinically meaningful improvements for the primary and major secondary endpoint in plaque psoriasis

Celgene has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving Apremilast 30 mg BID monotherapy in both the ESTEEM 1 and 2 phase ... read article

Kadcyla, a new treatment for late-stage breast cancer, approved by Food and Drug Administration

The U.S. Food and Drug Administration ) has approved Kadcyla ( Ado-Trastuzumab Emtansine ), a new therapy for patients with HER2-positive, late-stage ( metastatic ) breast cancer.HER2 is a protein inv ... read article

FISSION and NEUTRINO trial: Sofosbuvir has met primary endpoints for hepatitis C

Results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide Sofosbuvir in combination with Ribavirin ( FISSION ) and in combination with Ribavirin ... read article

Increased risk of high-grade prostate cancer with 5-alpha reductase inhibitors

Men aged 55 and over with a normal digital rectal examination and PSA less than or equal to 3.0 ng/mL at baseline taking Finasteride 5 mg/day ( 5 times the dose of Propecia ) in the 7-year Prostate Ca ... read article

Castration-resistant prostate cancer: Cabozantinib linked to high rates of complete or partial bone scan resolution, pain relief, improvements in hemoglobin, and tumor regression

Exelixis has reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer ( CRPC ) treated with Cabozantinib ( XL184; Cometriq ) in an ongoing phase 2 ... read article