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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

Cobimetinib in combination with Vemurafenib in patients with BRAF V600 mutation-positive advanced melanoma

Positive overall survival results from coBRIM, the phase 3 pivotal trial evaluating Cobimetinib, a specific MEK inhibitor, in combination with Vemurafenib in previously untreated patients with unresec ... read article

Lesinurad for treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor

The US Food and Drug Administration’s ( FDA ) Arthritis Advisory Committee ( AAC ) voted 10 to 4 to recommend the approval of Lesinurad 200mg tablets for the treatment of hyperuricemia associated with ... read article

Myocardial infarction: lower dosage of beta-blockers may decrease mortality

Patients treated with a lower dosage of beta-blockers following their myocardial infarction survived at the same rate, or even better rates, than patients on the high doses. More precisely, the patie ... read article

Combination of Sacubril and Valsartan for treatment of symptomatic chronic heart failure with reduced ejection fraction: CHMP has adopted a positive opinion

The Committee for Medicinal Products for Human Use ( CHMP ) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Entresto, intended for the trea ... 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

FDA has approved Eliquis to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation

The FDA ( Food and Drug Administration ) has approved the anti-clotting drug Eliquis ( Apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots ( systemic embolism ) in p ... read article

Chronic hepatitis C: Promacta for patients with thrombocytopenia to allow the initiation and maintenance of Interferon-based therapy

GlaxoSmithKline ( GSK ) has announced that the FDA ( Food and Drug Administration ) has approved Promacta ( Eltrombopag; in Europe: Revolade ) for the treatment of thrombocytopenia in patients with ch ... read article

Bosulif for chronic myelogenous leukemia, approved by Food and Drug Administration

The FDA ( Food and Drug Administration ) has approved Bosulif ( Bosutinib ) to treat chronic myelogenous leukemia ( CML ), a blood and bone marrow disease that usually affects older adults.An estimate ... 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