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Sandoz proposed biosimilar pegfilgrastim accepted by EMA
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...
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Novartis
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Revolade shows long-term disease control for immune thrombocytopenia
Novartis has announced long-term study results supporting the positive safety and efficacy of Revolade in adults with chronic/persistent immune thrombocytopenia...
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Novartis announces new CEO
Novartis announces CEO Joseph Jimenez to retire from Novartis in 2018. Vasant Narasimhan appointed CEO, effective February 1, 2018.
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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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Venture launched for a novel compound against malaria
A patient trial for KAF156, a next-generation antimalarial compound with the potential to treat drug-resistant strains of the malaria parasite has been launched...
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Biopharma stages a strong recovery
After the first half of 2017 biopharma investors are in a position to be exuberant, the threat of US price controls that have overshadowed the sector for a year have largely disappeared...
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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...
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Novartis combination targeted therapy receives FDA approval
The FDA has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer.
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Heart failure market worth $16 billion by 2026 as Novartis’ drug triggers growth
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…
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Sandoz receives EU approval for Erelzi (biosimilar etanercept)
The European Commission (EC) has approved Sandoz’ (a Novartis division) Erelzi (biosimilar etanercept) for use in Europe, to treat inflammatory diseases...
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Novartis & Bristol-Myers Squibb to collaborate on cancer treatments
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...
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FDA approves Roche’s lung cancer companion diagnostic
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...
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EMA to review Sandoz biosimilars adalimumab and infliximab
Sandoz announced that the EMA has accepted for regulatory review for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab)...
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FDA approves expanded use of Novartis’ lung cancer drug Zykadia
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...
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Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research
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
