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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

Locally advanced basal cell carcinoma: positive CHMP opinion for Odomzo

The CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Odomzo, intended for the tr ... read article

Advanced melanoma: positive CHMP opinion for Keytruda

The CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Keytruda, intended as monot ... read article

Severe asthma and tailored therapy

Patients with severe asthma or chronic obstructive pulmonary disease ( COPD ) have often a suboptimal symptom control due to inadequate treatment. A better understanding of pathogenetic mechanisms, ph ... read article

Specific reversal agent Idarucizumab led to immediate, complete and sustained reversal of Dabigatran in healthy individuals

The Lancet has published results from a healthy volunteer study investigating the reversal of the anticoagulant effect of Pradaxa ( Dabigatran etexilate ) by its specific reversal agent Idarucizumab. ... read article

Patients with cardiac events: cardiac safety of Tiotropium in a retrospective analysis of the UPLIFT

Tiotropium ( Spiriva ) is an anticholinergic bronchodilator for symptom relief and reducing exacerbations with an established safety profile in patients with chronic obstructive pulmonary disease ( CO ... read article

NICE has recommended Vargatef in combination with Docetaxel, as a new treatment option for patients with locally advanced metastatic or locally recurrent NSCLC of adenocarcinoma histology after first-line chemotherapy

National Institute for Health and Care Excellence ( NICE ) in the UK, has recommended Vargatef ( Nintedanib ) in combination with Docetaxel for use within the National Health Service ( NHS ) in Englan ... read article

Keytruda, an anti-PD-1 therapy, in advanced non-small cell lung cancer

The supplemental Biologics License Application ( sBLA ) for anti-PD-1 therapy, Keytruda ( Pembrolizumab ), for the treatment of patients with advanced non-small cell lung cancer ( NSCLC ) whose diseas ... read article

Orkambi improves lung function and reduces pulmonary exacerbations in people with cystic fibrosis who have two copies of the F508del mutation

The New England Journal of Medicine ( NEJM ) has published data from the two phase 3 studies of Orkambi ( Lumacaftor / Ivacaftor ), an investigational medicine designed to treat the underlying cause o ... read article

Olodaterol: use in chronic obstructive pulmonary disease

Olodaterol ( Striverdi Respimat ) is an inhaled long-acting beta2-adrenoceptor agonist ( LABA ) indicated as a once-daily maintenance bronchodilator therapy in adults with COPD. Several well-desig ... 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