News

Enlarge image

BusinessBelgiumUKEU

EMA may not publish trial data

03.05.2013 - A Court decision may delay the timely implementation of the EU clinical trials regulation. Two firms have sued the EMA over confidentiality breaches.

The General Court of the European Union ordered the EMA not to provide any raw data on pivotal clinical trials of EU-approved drugs to competitors of originator drugs' developers. Upon request of three biosimilar makers, the EU Agency had disseminated patient-level clinical data on Abbvie's US$9.3bn arthritis blockbuster Humira and InterMune's orphan drug Esbriet, a TGF-beta blocker loosing market exclusivity in 2014. On the day of the Court's decision, the EMA published its final advice on the proactive publication of clinical raw data aimed at creating more transparency towards market authorisation of medicines.  

 "If the court decides we have to stop the release of data, I think that would be the worst possible boomerang for the industry," EMA chief Guido Rasi told Reuters in an interview. "The most powerful weapon we have to tackle distrust is transparency." After the EU ombudsman three years ago decided that the Agency "may not withhold data from clinical studies referring to commercial confidentiality", the EMA had tabled plans to grant open access to clinical raw data of approved medicines. The rules are a pillar of the new clinical trials regulations.  

The General Court, however, ordered the EMA not to provide any documents to the drugmakers which filed the Freedom of Information requests, at least until a final ruling is given. Nonetheless, the agency plans to continue releasing documents on a case-by-case basis, depending upon the outcome of these challenges. The move of of Abbvie and Intermune is backed by the US organisation Phrama, who believes that the EMA's policies fail to respect the principle of  responsible data sharing.  Since the challenges were filed, the EMA claims to have received more than 30 statements of support. Conversely, US and European pharmaceutical industry trade groups have filed papers supporting the drugmakers.  

"The interim ruling must not delay the timetable for introducing a modernised Clinical Trial Regulation for Europe, believes Steve Bates, CEO of the BioIndustry Association (BIA). The BIA said, it welcomes the publication of the EMA's final advice and looks forward to contributing to the consultation on the EMA draft policy."

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-02/ema-may-not-publish-trial-data.html

ResearchEUUK

27.07.2016 In view of the Brexit, research academies across Britain are calling for a “bold commitment” from the government. The Royal Society President urges the UK government to underwrite the research of British scientists applying for EU funding.

FinancingBelgium

20.07.2016 Belgian molecular diagnostics company Biocartis Group NV has raised €55m and will use the funds mainly to expand manufacturing capacities for its PCR-based molecular diagnostics system Idylla.

Stock marketsFranceEU

19.07.2016 It is Europe’s first gene therapy company to float on Euronext: Gensight raised €40m in its IPO. And it is not the only French company that has taken the leap in an uncertain market climate – Alzheimer’s expert Pharnext also went public.

ResearchUK

18.07.2016 When NASA blasted off to the International Space Station on Monday morning, it had UK tech on board. A miniature DNA sequencer from Oxford Nanopore will be used to keep an eye on the ISS atmosphere – and may even analyse alien DNA one day.

M&AUKSwitzerland

13.07.2016 Cell Medica has acquired Swiss antibody specialist Delenex Therapeutics. The deal nets the British cellular therapeutics developer Delenex’ proprietory antibody fragment platform Pentrabody.

R&DAustriaFrance

12.07.2016 Vienna-based vaccine specialist Themis Bioscience GmbH has secured broad access to a promising virus vaccine vector tech by extending its license agreement with French Institut Pasteur. Its goal: to develop a Zika vaccine.

M&AFranceEU

07.07.2016 Californian biopharma Medivation has agreed to confidential negotiations with its suitors, in particular the French pharmaceutical company Sanofi, which aggressively has buffeted the cancer therapy specialist for months.

Prenatal DiagnosticsEUUK

06.07.2016 The European Commission started an investigation into Illumina’s and Sequenom’s 2014 patent agreement, UK-competitor Premaitha Health said. The two US companies had agreed to pool their Noninvasive Prenatal Testing IP.

GenericsSpainGermanyEU

04.07.2016 Cinfa Biotech is shuffling for position on the lucrative biosimilar market. The Spanish-German company has published positive results in a study for a pegfilgrastim copycat with 172 healthy volunteers in Germany.

Drug discoveryUKSwitzerland

30.06.2016 UK’s Heptares Therapeutics and Paul Scherrer Institute spinoff leadXpro will collaborate to find new approaches for the determination of high-res X-ray structures of G protein-coupled receptors to find new drugs.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • NEWRON (CH)18.50 CHF9.14%
  • GENMAB (DK)1210.00 DKK5.68%
  • VALNEVA (F)2.42 EUR5.68%

FLOP

  • KAROLINSKA (S)7.30 SEK-3.95%
  • BIOTIE THERAPEUTICS (FI)0.27 EUR-3.57%
  • SAREUM HOLDINGS (UK)0.60 GBP-3.23%

TOP

  • THERAMETRICS (CH)0.05 CHF66.7%
  • PROTHENA PLC (IE)51.61 USD52.6%
  • FLAMEL TECHNOLOGIES (F)12.71 USD34.6%

FLOP

  • MOLOGEN (D)1.80 EUR-28.9%
  • EVOCUTIS (UK)0.04 GBP-20.0%
  • SAREUM HOLDINGS (UK)0.60 GBP-20.0%

TOP

  • KARO BIO (S)31.10 SEK1893.6%
  • NICOX (F)11.17 EUR469.9%
  • SAREUM HOLDINGS (UK)0.60 GBP160.9%

FLOP

  • BB BIOTECH (D)44.69 EUR-84.0%
  • NEUROVIVE PHARMACEUTICAL AB (S)4.87 SEK-77.7%
  • EVOCUTIS (UK)0.04 GBP-76.5%

No liability assumed, Date: 26.07.2016