18.03.2013 - After having shown an 80% response rate in lung cancer patients, the US-FDA has granted breakthrough status to Novartis’ Phase I ALK blocker LDK378.
The novel „breakthrough status“ opens up the possibility to Novartis to conduct only one instead further two clinical study phases before bringing the compound to the market. Novartis, which had already begun recruiting patients for several Phase II studies with LDK378 to improve treatment for patients with metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) mutations is slated to start phase III testing this year. The company, which started clinical testing of LDK378 in 2011, said, it plans to file for market authorisation at the beginning of 2014.
The LDK378 treatment will be made available to a subgroup of patients who did not respond sufficiently to crizotinib treatment and who suffers from limited treatment options. In a Phase I trial Novartis’ "breakthrough drug" showed 80% response rate in 88 patients with advanced ALK-positive NSCLC, which makes about 8% of all NSCLC cases. LDK378 is a highly selective inhibitor of an important cancer target, anaplastic lymphoma kinase (ALK). Because it is an investigational compound, the safety and efficacy profile of LDK378 has not yet been established.
17.04.2014 The European Parliament has given green light to the second Innovative Medicines Initiative with the aim to advance pharmacological research and development, particularly in areas of unmet medical need.
11.04.2014 There is no evidence that neuraminidase inhibitors Tamiflu and Relenza prevent complications of influenza or reduce hospital admissions. In addition, it is unclear whether they can stop the spread of influenza in case of outbreaks, says a report by the Cochrane Collaboration.
09.04.2014 Roche is extending its involvement in the area of point-of-care diagnostics by taking over US company Iquum. In the field of epigenetics, the Swiss pharma company has started a cooperation with the Spanish company Oryzon.
08.04.2014 The Swiss Biotech Report 2014 presented in Zurich sees an encouraging upturn in the country's biotech scene. However, the acceptance of the mass immigration initiative poses a significant threat.
The LiposoFast-Basic produces unilamellar liposomes by the manual extrusion of a multilamellar liposome suspension through a polycarbonate membrane of defined pore size, using gas-tight, glass syringes. more