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

Clinical ResearchFrancePortugalEU

05.02.2016 It is not yet clear why a man died during a first-in-man clinical trial in January. However, a preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

M&ASwitzerland

04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.

FinancingEUUKBelgium

01.02.2016 Newly formed Medicxi Ventures, a life sciences-dedicated VC firm based in London, Geneva and Jersey, has closed a €210m investment fund to reinvest in European early-stage assets.

ResearchUKEU

01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.

M&ASwedenIceland

28.01.2016 Swedish infectious disease specialist Enzymatica has bagged Icelandic company Zymetech, who produces the patent-protected enzyme used in Enzymatica’s own common cold blocker ColdZyme.

R&DUK

27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.

Clinical TrialsGermany

25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.

AMREU

21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.

M&AFinland

19.01.2016 Biotie Therapies has long been expanding its business in the US. Now, the Finnish company is set to be taken over by US company Acorda Therapeutics, which is paying €321m for the shares.

Drug AssessmentPortugalFrance

18.01.2016 A Phase I clinical trial for a drug developed by Portuguese pharma company Bial has ended in disaster. One man died, five others may have irreversible neurological damage.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MAGFORCE (D)5.25 EUR5.00%
  • SCANCELL HOLDINGS (UK)18.25 GBP4.29%
  • SUMMIT (UK)4.03 GBP3.87%

FLOP

  • SWEDISH ORPHAN BIOVITRUM (S)12.45 USD-23.38%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • IMMUPHARMA (UK)25.50 GBP-12.07%

TOP

  • EPIGENOMICS (D)4.46 EUR109.4%
  • VERONA PHARMA (UK)3.40 GBP28.3%
  • WILEX (D)2.09 EUR19.4%

FLOP

  • PROTHENA PLC (IE)34.27 USD-39.1%
  • PLETHORA (UK)2.75 GBP-33.3%
  • BIONOR PHARMA (N)0.88 NOK-30.2%

TOP

  • KARO BIO (S)26.80 SEK3728.6%
  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • 4SC (D)3.33 EUR291.8%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)8.80 SEK-85.6%
  • BIOTEST (D)14.11 EUR-84.5%
  • EVOCUTIS (UK)0.08 GBP-71.4%

No liability assumed, Date: 06.02.2016