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

BusinessUK

20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.

BusinessEUGermanyUK

15.08.2014 Some of Europe’s biggest pharma companies are competing in a bidding war for US biotech Intermune Inc., Bloomberg reports, citing insider reports as the source.

ResearchEUGermanyUK

13.08.2014 The Ebola epidemic is still raging on in West Africa and thus far there is

neither vaccine nor cure for the viral disease. The only flickers of hope:

an experimental antibody serum and an early-stage vaccine.

BusinessFrance

11.08.2014 Will Sanofi succeed where Pfizer failed? The French pharmaceutical company has taken on the commercialisation of Mannkind Corporation’s inhaled insulin product Afrezza.

ResearchSwedenGermany

08.08.2014 Boehringer Ingelheim is walking away from Swedish Orexo's prostaglandin inhibition project OX-MPI. Germany's largest researching pharmaceutical company had been responsible for the project's research and development since 2005.

ResearchSwitzerlandDenmark

06.08.2014 Roche is re-expanding its involvement in RNAi technologies. The Swiss pharmaceutical company will pay up to €335m for the acquisition of the Danish company Santaris Pharma A/S.

ResearchUKSwitzerland

03.08.2014 In its efforts to become the leading country in genetic research, the UK has attracted investments worth more than £300m (€376m) to map 100,000 human genomes by 2017.

BusinessSpainUKSweden

31.07.2014 Astrazeneca is buying the rights to Almirall’s respiratory drugs in a deal worth up to €1.56bn.

BusinessFranceGermanySwitzerlandUK

30.07.2014 Rumours have it that French Danone wants to sell its medical nutrition business to US drugmaker Hospira for US$5bn in yet another tax inversion deal.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • SANTHERA80.00 CHF6.74%
  • WILEX2.26 EUR1.80%
  • ADDEX4.07 CHF1.75%

FLOP

  • MOLOGEN7.30 EUR-6.41%
  • 4SC1.16 EUR-3.33%
  • EVOLVA1.27 CHF-2.31%

TOP

  • SANTHERA80.00 CHF15.4%
  • MAGFORCE6.47 EUR9.7%
  • CYTOS0.27 CHF8.0%

FLOP

  • WILEX2.26 EUR-27.6%
  • MOLOGEN7.30 EUR-22.3%
  • 4SC1.16 EUR-20.0%

TOP

  • SANTHERA80.00 CHF3709.5%
  • CO.DON2.50 EUR228.9%
  • PAION2.41 EUR190.4%

FLOP

  • CYTOS0.27 CHF-93.3%
  • MEDIGENE4.60 EUR-68.1%
  • MERCK KGAA64.23 EUR-45.8%

No liability assumed, Date: 21.08.2014