News

Treating the cause
Enlarge image

ResearchUKEU

Treating the cause

29.05.2012 - A positive recommendation by EMA's CHMP committee raises hope for patients with cystic fibrosis in Europe.

London – The EU agency recommended Kalydeco (ivacaftor) from the US-biotech Vertex for approval. The treatment targets patients from the age of six years on who have a G551D mutation in the cystic fibrosis transmembrane regulator (CFTR) gene.

Kalydeco was already approved by the FDA at the end of January this year. According to the European agency, Kalydeco offers an innovative therapeutic approach for patients with cystic fibrosis: it is the first treatment that targets the underlying mechanism of the disease, by restoring the function of the mutated CFTR protein.

Currently available therapies for patients with cystic fibrosis only address the consequences of the disease, not the underlying defect. Clinical studies showed that Kalydeco improved pulmonary function in cystic fibrosis patients with the specific G551D-CFTR mutation. About half of the world's CF patients reside in Europe, where about 35,000 people have the disease. The European Commission will consider the CHMP's recommendation in its final decision on Kalydeco. According to PM live, the European recommendation comes almost four months after Kalydeco was cleared by the US Food and Drug Administration (FDA), with the US agency taking just three months to review Vertex' marketing application. This backs outcomes from a recent report that described how the FDA had a faster approval process than the EMA.

Update: After releasing this news, Vertex corrected trial data of Kalydeco.

http://www.european-biotechnology-news.com/news/news/2012-02/treating-the-cause.html

EbolaEUFrance

30.09.2014 In the face of the Ebola outbreak sweeping the West African countries, the EMA has started to review investigational treatments for the deadly virus disease.

FinancingSwitzerlandGermanyNetherlandsFrance

26.09.2014 Biotechnology has made the news in the stock market this month, as a wave of companies announced plans to launch IPOs on European exchanges later this year.

ResearchGermany

25.09.2014 After being hit hard by the Andromeda trial data falsification scandal, German biotech Evotec is moving back into calmer waters with new MS research projects.

FinancingNetherlands

23.09.2014 Dutch Biotech VC firm Aglaia has launched a new US$65m fund targeted towards biotechnology startups working on groundbreaking technologies aimed at preventing and curing cancer.

BusinessGermany

19.09.2014 In order to concentrate on the life science business, German industry giant Bayer is splitting off its plastics subgroup as a separate company.

FinanceSwitzerland

18.09.2014 Swiss biopharma Cardiorentis has received a €45m investment from overseas investment firm Healthcare Royalty Partners in order to finance the registration for its heart drug.

PoliticsEU

15.09.2014 Jean Claude Juncker, the European Commission President-elect revealed his new Commissioners last week, whilst announcing a change in the units dealing with medicines, medical devices and health technology.

BiosimilarsGermanyFrance

12.09.2014 The 2011 collaboration of Boehringer Ingelheim and Eli Lilly is bearing fruit. An insulin biosimilar developed through the partnership has now been approved in Europe - the first-ever generic version of this class.

FinancingNetherlands

11.09.2014 Cystic fibrosis specialist Proqr Therapeutics has set the terms for its upcoming IPO at US-American stock exchange NASDAQ.

Clinical TrialsUKSweden

09.09.2014 In the midst of the hustle and bustle of the European Respiratory Society’s International Congress 2014, Astrazeneca quietly announced the disappointing results of its latest benralizumab study.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • CO.DON3.13 EUR5.03%
  • 4SC1.06 EUR3.92%
  • SANTHERA88.65 CHF2.78%

FLOP

  • CYTOS0.19 CHF-9.52%
  • WILEX2.13 EUR-6.99%
  • FORMYCON8.03 EUR-5.42%

TOP

  • PAION3.18 EUR33.6%
  • CO.DON3.13 EUR27.8%
  • FORMYCON8.03 EUR14.2%

FLOP

  • CYTOS0.19 CHF-26.9%
  • ADDEX3.13 CHF-18.1%
  • EVOTEC3.06 EUR-16.8%

TOP

  • SANTHERA88.65 CHF2155.7%
  • PAION3.18 EUR224.5%
  • CO.DON3.13 EUR222.7%

FLOP

  • CYTOS0.19 CHF-95.2%
  • 4SC1.06 EUR-43.9%
  • THERAMETRICS0.08 CHF-42.9%

No liability assumed, Date: 30.09.2014