Consortium established to support ICH M7 compliance
An industry work-group comprising of toxicologists, pharmaceutical companies and data experts plans to unveil the early results of a data sharing project...
List view / Grid view
An industry work-group comprising of toxicologists, pharmaceutical companies and data experts plans to unveil the early results of a data sharing project...
The FDA has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer.
The heart failure space across the seven key markets of the US, France, Germany, Italy, Spain, the UK and Japan is set to grow from $3.7 billion in 2016 to around $16.1 billion by 2026, representing an impressive compound annual growth rate of 15.7%, according to research and consulting firm…
The European Commission (EC) has approved Sandoz’ (a Novartis division) Erelzi (biosimilar etanercept) for use in Europe, to treat inflammatory diseases...
7 June 2017 | By Niamh Marriott, Junior Editor
Novartis has entered into a research collaboration in which Bristol-Myers Squibb will investigate the safety, tolerability, and efficacy of Mekinist...
6 June 2017 | By Niamh Marriott, Junior Editor
The FDA have approved Roche’s VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients...
Sandoz announced that the EMA has accepted for regulatory review for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab)...
30 May 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) approved the expanded use of Novartis’ Zykadia (ceritinib) to include patients with NSCLC...
16 May 2017 | By European Federation of Pharmaceutical Industries and Associations (EFPIA)
The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with quality medicines
10 May 2017 | By Niamh Marriott, Junior Editor
This follows the initiation of the Phase IIb trial by Conatus evaluating emricasan in patients with decompensated liver cirrhosis caused by NASH...
4 May 2017 | By Niamh Marriott, Junior Editor
The drug is approved for use in combination with LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML...
28 April 2017 | By Niamh Marriott, Junior Editor
Novartis announced data from the MS-MRIUS study, which confirmed the effectiveness of Gilenya (fingolimod) in the real-world setting...
27 April 2017 | By Niamh Marriott, Junior Editor
Novartis has expanded their commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine...
20 April 2017 | By Niamh Marriott, Junior Editor
Novartis demonstrated that 58% of patients with treatment-naïve severe aplastic anemia (SAA) achieved complete response at six months when treated...
20 April 2017 | By Niamh Marriott, Junior Editor
Novartis has entered into a clinical trial agreement with Allergan to conduct a Phase IIb study, involving the combination of a Novartis’ FXR agonist...