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FDA backs NSCLC drug development

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. 

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/nsclc-drug-gets-breakthrough-status.html

R&DUKIreland

29.07.2016 GlaxoSmithKline has in-licensed Janssen’s anti-IL-33R monoclonal antibody for severe asthma. The British drugmaker is paying €208m up front for the mAb.

ResearchEUUK

27.07.2016 In view of the Brexit, research academies across Britain are calling for a “bold commitment” from the government. The Royal Society President urges the UK government to underwrite the research of British scientists applying for EU funding.

FinancingBelgium

20.07.2016 Belgian molecular diagnostics company Biocartis Group NV has raised €55m and will use the funds mainly to expand manufacturing capacities for its PCR-based molecular diagnostics system Idylla.

Stock marketsFranceEU

19.07.2016 It is Europe’s first gene therapy company to float on Euronext: Gensight raised €40m in its IPO. And it is not the only French company that has taken the leap in an uncertain market climate – Alzheimer’s expert Pharnext also went public.

ResearchUK

18.07.2016 When NASA blasted off to the International Space Station on Monday morning, it had UK tech on board. A miniature DNA sequencer from Oxford Nanopore will be used to keep an eye on the ISS atmosphere – and may even analyse alien DNA one day.

M&AUKSwitzerland

13.07.2016 Cell Medica has acquired Swiss antibody specialist Delenex Therapeutics. The deal nets the British cellular therapeutics developer Delenex’ proprietory antibody fragment platform Pentrabody.

R&DAustriaFrance

12.07.2016 Vienna-based vaccine specialist Themis Bioscience GmbH has secured broad access to a promising virus vaccine vector tech by extending its license agreement with French Institut Pasteur. Its goal: to develop a Zika vaccine.

M&AFranceEU

07.07.2016 Californian biopharma Medivation has agreed to confidential negotiations with its suitors, in particular the French pharmaceutical company Sanofi, which aggressively has buffeted the cancer therapy specialist for months.

Prenatal DiagnosticsEUUK

06.07.2016 The European Commission started an investigation into Illumina’s and Sequenom’s 2014 patent agreement, UK-competitor Premaitha Health said. The two US companies had agreed to pool their Noninvasive Prenatal Testing IP.

GenericsSpainGermanyEU

04.07.2016 Cinfa Biotech is shuffling for position on the lucrative biosimilar market. The Spanish-German company has published positive results in a study for a pegfilgrastim copycat with 172 healthy volunteers in Germany.

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No liability assumed, Date: 30.07.2016