News

EMA limits use for MS pill Gilenya
Enlarge image

BusinessSwitzerlandEU

EMA limits use for MS pill Gilenya

23.04.2012 - Novartis' multiple sclerosis pill Gilenya will have its label updated in the EU, enabling physicians to better manage potential adverse effects on the heart.

London  – The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that all patients beginning treatment with Gilenya (fingolimod) should have an electrocardiogram before taking the first dose and for six hours after. The body also recommends regular blood pressure and heart rate monitoring. The CHMP advises that heart activity monitoring should be extended for patients whose heart rate is lowest six hours after receiving the first dose, and that patients who develop clinically significant problems like bradycardia or atrioventricular block should be monitored until the problems have been resolved. The CHMP also adds that doctors should no longer prescribe the drug to patients with cardiovascular and cerebrovascular disease, or to patients on heart-rate lowering medications. But if these patients must receive Gilenya, their heart activity must be monitored at least over night after taking the first dose

Gilenya has been authorised in the European Union (EU) since March 2011 for the treatment of relapsing-remitting MS in patients who have not responded to treatment with beta-interferon or whose disease is severe and getting worse rapidly. It is the first disease-modifying MS treatment available as an oral formulation.

The EMA began a review of the drug in January following reports of heart problems in patients taking Gilenya. The CHMP looked at all available data on heart safety, including reports of 15 cases of sudden or explained death in patients treated with Gilenya. Most deaths occurred in patients with cardiovascular problems or those taking other medicines. However, it is still not clear if Gilenya was the cause of death. According to Novartis, some 36,000 patients have received treatment with Gilenya since February

http://www.european-biotechnology-news.com/news/news/2012-02/ema-limits-use-for-ms-pill-gilenya.html

ResearchUK

30.01.2015 AstraZeneca has joined forces with four research collaborations to use breakthrough CRISPR gene editing technology across its drug discovery platform.

Stock marketsEU

29.01.2015 Denmark's Ascendis Pharma has successfully raised US$108m with its upsized NASDAQ IPO, while Irish animal health specialist Nexvet is waiting in the wings.

Contract ResearchEU

28.01.2015 EMA recommends suspending around 750 generic medicines marketed throughout the world after India’s GVK Biosciences is accused of faking bioequivalence studies. Meds considered critically important for patients will remain available.

RegulationEU

21.01.2015 The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.

Stock marketsEUGermany

21.01.2015 2014 was a record year for biotech companies on the European stock market, with a total of €2.4bn raised in the year - 25% more than in the year before.

ResearchEUUK

20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck. 

Stock ExchangeUKDenmarkFrance

16.01.2015 It's time to get used to weekly IPO plans by European biotechs. UK's drug discovery firm Redx Pharma Ltd, established just five years ago, has come of age with their £80m (€105m) IPO plans.

M&ASwitzerland

14.01.2015 Pharma kingpin Roche has launched a billion-dollar transaction for a total of US$1.2bn (€1bn), taking over the majority of US cancer specialist Foundation Medicine.

PoliticsEU

14.01.2015 The European Parliament has backed the legislation allowing individual countries to restrict or prohibit the cultivation of genetically modified crops that have been authorised at EU level.

M&AIrelandUK

13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC0.84 EUR0.00%
  • ACTELION100.80 CHF0.00%
  • ADDEX3.28 CHF0.00%

FLOP

  • CYTOTOOLS31.45 EUR-0.47%
  • 4SC0.84 EUR0.00%
  • ACTELION100.80 CHF0.00%

TOP

  • CYTOS0.36 CHF56.5%
  • FORMYCON15.48 EUR53.6%
  • ADDEX3.28 CHF41.4%

FLOP

  • BIOFRONTERA1.93 EUR-16.1%
  • ACTELION100.80 CHF-13.3%
  • MOLOGEN5.75 EUR-9.4%

TOP

  • SANTHERA105.00 CHF2544.8%
  • WILEX1.96 EUR168.5%
  • FORMYCON15.48 EUR103.7%

FLOP

  • CYTOS0.36 CHF-90.1%
  • 4SC0.84 EUR-49.7%
  • MOLOGEN5.75 EUR-49.7%

No liability assumed, Date: 31.01.2015