News

Enlarge image

RegulatorySwitzerland

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

Clinical ResearchFrancePortugalEU

05.02.2016 It is not yet clear why a man died during a first-in-man clinical trial in January. However, a preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

M&ASwitzerland

04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.

FinancingEUUKBelgium

01.02.2016 Newly formed Medicxi Ventures, a life sciences-dedicated VC firm based in London, Geneva and Jersey, has closed a €210m investment fund to reinvest in European early-stage assets.

ResearchUKEU

01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.

M&ASwedenIceland

28.01.2016 Swedish infectious disease specialist Enzymatica has bagged Icelandic company Zymetech, who produces the patent-protected enzyme used in Enzymatica’s own common cold blocker ColdZyme.

R&DUK

27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.

Clinical TrialsGermany

25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.

AMREU

21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.

M&AFinland

19.01.2016 Biotie Therapies has long been expanding its business in the US. Now, the Finnish company is set to be taken over by US company Acorda Therapeutics, which is paying €321m for the shares.

Drug AssessmentPortugalFrance

18.01.2016 A Phase I clinical trial for a drug developed by Portuguese pharma company Bial has ended in disaster. One man died, five others may have irreversible neurological damage.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MAGFORCE (D)5.25 EUR5.00%
  • SCANCELL HOLDINGS (UK)18.25 GBP4.29%
  • SUMMIT (UK)4.03 GBP3.87%

FLOP

  • SWEDISH ORPHAN BIOVITRUM (S)12.45 USD-23.38%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • IMMUPHARMA (UK)25.50 GBP-12.07%

TOP

  • EPIGENOMICS (D)4.46 EUR109.4%
  • VERONA PHARMA (UK)3.40 GBP28.3%
  • WILEX (D)2.09 EUR19.4%

FLOP

  • PROTHENA PLC (IE)34.27 USD-39.1%
  • PLETHORA (UK)2.75 GBP-33.3%
  • BIONOR PHARMA (N)0.88 NOK-30.2%

TOP

  • KARO BIO (S)26.80 SEK3728.6%
  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • 4SC (D)3.33 EUR291.8%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)8.80 SEK-85.6%
  • BIOTEST (D)14.11 EUR-84.5%
  • EVOCUTIS (UK)0.08 GBP-71.4%

No liability assumed, Date: 06.02.2016