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

M&AUKItaly

17.10.2014 One of the biggest pharma mergers of the year has been called off. Abbvie has dropped plans to acquire UK’s Shire following new US tax rules.

FinancingUKBelgium

15.10.2014 Bicycle Therapeutics wins €25m backing by major pharma venture capitalists for the development of a new class of oncology drugs.

FinancingGermanySwitzerlandNetherlands

13.10.2014 Biotechnology IPOs are back in fashion – German Probiodrug AG wants to raise €32m with its IPO, whilst Swiss Molecular Partners AG hopes the launch of its IPO will gain a revenue of €145m.

BusinessIreland

10.10.2014 Actavis has announced plans to merge with American pharma company Durata - a move that will strengthen their infectious diseases portfolio.

RegulationEU

07.10.2014 In an unprecedented move, the European Medicines Agency has approved a system allowing the future analysis of clinical trial data.

FinanceNetherlandsEU

06.10.2014 Another fund from the Netherlands has raised €92m in its first close and will invest the money in companies developing innovative therapeutics, medical devices and diagnostics.

FinanceNetherlandsUKSwitzerland

03.10.2014 Dutch venture capitalist LSP has achieved its monetary milestone by raising €80m for its fifth fund - with a goal of €150m.

PoliticsEULithuaniaPoland

02.10.2014 New EU commission chief Jean-Claude Juncker is on the defensive after members of Parliament and NGOs criticised his reorganisation of the health technology units.

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.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC0.88 EUR0.00%
  • ACTELION98.55 CHF0.00%
  • ADDEX3.20 CHF0.00%

FLOP

  • CYTOTOOLS31.45 EUR-0.47%
  • 4SC0.88 EUR0.00%
  • ACTELION98.55 CHF0.00%

TOP

  • BIOFRONTERA2.84 EUR29.1%
  • ADDEX3.20 CHF3.2%
  • CYTOTOOLS31.45 EUR0.0%

FLOP

  • CYTOS0.15 CHF-37.5%
  • PAION2.16 EUR-29.2%
  • MOLOGEN5.53 EUR-28.2%

TOP

  • SANTHERA80.55 CHF2088.9%
  • CO.DON2.44 EUR149.0%
  • PAION2.16 EUR134.8%

FLOP

  • CYTOS0.15 CHF-96.2%
  • 4SC0.88 EUR-50.0%
  • THERAMETRICS0.07 CHF-50.0%

No liability assumed, Date: 19.10.2014