MedicineNews.net - Medical Updates

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

TOWER trial: Blinatumomab met primary endpoint of overall survival in patients with B-cell precursor acute lymphoblastic leukemia

The results of a prespecified interim analysis have shown that the primary endpoint of improved overall survival was met in the phase 3 TOWER study. The randomized, open-label TOWER study evaluated ... read article

Candesartan or other sartans could have a role in Alzheimer's disease treatment

According to researchers at Georgetown University Medical Center ( GUMC ) and at National Institutes of Health ( NIH ), in laboratory neuronal cultures, a drug used to treat high blood pressure reduc ... read article

Pembrolizumab for the treatment of non-small cell lung carcinoma

Immune checkpoint inhibitors targeting programmed death protein 1 ( PD-1 ) receptor and its ligand, PD-L1, have recently led to significant and durable improvements in the clinical outcomes of some ty ... read article

FDA has approved Afstyla, the first and only recombinant Factor VIII single chain therapy for hemophilia A

The FDA ( U.S. Food and Drug Administration ) has approved Afstyla [ Antihemophilic Factor ( Recombinant ), Single Chain ], a novel long-lasting recombinant factor VIII single-chain therapy for adults ... read article

PI3K/mTOR pathway as a potential therapeutic target for melanoma intrinsically resistant to BRAF inhibitors

Dysregulation of receptor tyrosine kinases ( RTKs ) contributes to several aspects of oncogenesis including drug resistance. In melanoma, distinct RTKs have been involved in BRAF inhibitors ( BRAFi ) ... read article

Giotrif, overall survival benefit for patients with EGFR mutation-positive non-small cell lung cancer

The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion for an update to the European label for Giotrif ( Afatinib ), strengt ... read article

Selumetinib, a MEK inhibitor, in combination with Dacarbazine does not effective in uveal melanoma

The phase 3 SUMIT study of Selumetinib in combination with Dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. Th ... read article

BACE inhibitors: BI 1181181 voluntarily put on temporary clinical hold for safety evaluation

Vitae Pharmaceuticals has announced that its partner Boehringer Ingelheim has voluntarily placed BI 1181181 on a temporary clinical hold, and has notified regulatory agencies of its decision. BI 1 ... read article

COPD maintenance treatment, Spiolto Respimat approved in first European countries

Boehringer Ingelheim has announced regulatory authority approvals for Spiolto Respimat ( Tiotropium / Olodaterol ) in first European countries [ As of 29th June, Spiolto Respimat has been approved in ... read article