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Nivolumab in glioblastoma multiforme, CheckMate -143 did not meet its primary endpoint of improved overall survival

CheckMate -143, a randomized phase 3 clinical trial evaluating the efficacy and safety of Nivolumab ( Opdivo ) in patients with first recurrence of glioblastoma multiforme ( GBM ), did not meet its pr ... read article

Androgen receptor-inhibitors: Enzalutamide improves metastasis-free survival in patients with non-metastatic castration-resistant prostate cancer

The phase 3 PROSPER trial evaluating Enzalutamide ( Xtandi ) plus androgen deprivation therapy ( ADT ) versus ADT alone in patients with non-metastatic ( M0 ) castration-resistant prostate cancer ( CR ... read article

Parkinson's disease: Safinamide improves motor function, overall clinical status and health-related quality of life

Safinamide ( Xadago ) is an orally active, selective, reversible monoamine oxidase-B inhibitor with both dopaminergic and non-dopaminergic ( glutamatergic ) properties. In the European Union, Safi ... read article

Nivolumab in glioblastoma multiforme, CheckMate -143 did not meet its primary endpoint of improved overall survival

Advanced BRCA-related breast cancer: Olaparib, a PARP inhibitor, is superior to chemotherapy

During the American Society of Clinical Oncology ( ASCO ) Annual Meeting, the results of the phase III OlympiAD trial demonstrating for the first time that Olaparib ( Lynparza ) is superior to chemoth ... read article

Relapsing multiple sclerosis: oral Ozanimod has shown improvements compared to Interferon beta-1a for the primary endpoint of annualized relapse rate

SUNBEAM trial, evaluating the efficacy and safety of O)zanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis ( RMS ), met the primar ... read article

Actemra is the first FDA-approved treatment for adults with giant cell arteritis

The U.S. Food and Drug Administration ( FDA ) has approved Actemra [ European Union: RoActemra ] ( Tocilizumab ) subcutaneous injection for the treatment of giant cell arteritis ( GCA ), a chronic and ... read article

uniQure will not seek marketing authorization renewal for Glybera in European Union

uniQure has announced that it will not pursue the renewal of the Glybera ( Alipogene tiparvovec ) marketing authorization in Europe when it is scheduled to expire on October 25, 2017. According to ... read article

Lung cancer: patients with responsive to Nivolumab, an immunotherapic drug, beat standard odds of survival

More than seven years after the start of one of the first clinical trials of the immunotherapy drug Nivolumab ( Opdivo ), researchers at the Johns Hopkins Kimmel Cancer Center have reported that the f ... read article

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

Systemic lupus erithematosus: Benlysta wins backing from NICE

After previously rejecting the drug in 2011, NICE ( National Institute for Health and Care Excellence ) has approved lupus drug Benlysta ( Belimumab ) for limited use under a managed access scheme. ... 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

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