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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

M&AUKSweden

24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.

FinancingUK

23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.

R&DDenmark

19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.

ResearchUKEU

17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).

Stock marketsGermany

15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).

LicensingDenmark

11.08.2016 Danish Genmab AS has granted Gilead Sciences license to use its DuoBody technology platform to develop bispecific antibodies for the treatment of HIV. The deal is worth up to €252m.

Clinical developmentHungaryIreland

09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.

ImmunotherapySpain

08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.

ApprovalEU

04.08.2016 After a two-year pilot period, the EMA has published its report on its adaptive pathways approach. The agency plans to “explore the concept further” and will continue to accept proposals.

BusinessPolandUK

01.08.2016 Life science venture capital group Epidarex has launched Nodthera Ltd, a biotech based on research by Poland-based drug discovery company Selvita. The start-up aims to develop novel inhibitors of the NLRP3 inflammasome.

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No liability assumed, Date: 23.08.2016