News

EMA may not publish trial data
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

DiabetesFrance

01.09.2015 Sanofi is partnering up with Google’s life sciences team with an ambitious goal: to change the face of diabetes management.

M&ASwitzerlandFrance

31.08.2015 In order to boost its active cosmetic ingredients business, the Swiss flavour and fragrance giant Givaudan has acquired Volketswil-based Induchem Holding and all its subsidiaries.

BioeconomyEU

26.08.2015 In its second call for proposals, the Bio-Based Industries Joint Undertaking has earmarked €106m for the research and development of useful bio-based products.

OncologyNorway

25.08.2015 Oslo Cancer Cluster is inaugurating its NOK1bn (€107m) Innovation Park. None other than Norwegian prime minister Erna Solberg officially opened the doors to the research park on August 24th.

LicensingUKSwitzerland

21.08.2015 Novartis Pharma AG has secured all remaining rights to antibody hopeful ofatumumab. Seller GlaxoSmithKline is set to receive up to US$1bn (€919m) for the treatment for MS and other autoimmune indications.

LicensingDenmark

18.08.2015 Danish Novo Nordisk is climbing on the antibody therapeutics bandwagon in a US$500m licensing agreement with antibody-specialist Genmab.

M&ASwitzerland

13.08.2015 Roche is stepping up its commitment in the fight against drug resistant “superbugs” with its takeover of US diagnostics play Geneweave, for up to US$425m.

M&AUK

11.08.2015 Biotech bug controllers Oxitec has been bought by US biotech Intrexon Corporation for $160m (€145m). The Oxford University spin-out specialises in environmentally friendly technology to control pests such as mosquitoes, which cause dengue fever and other diseases.

Research and DevelopmentFranceGermany

07.08.2015 In a deal worth more than €300m, Sanofi has partnered up with German drug discovery and development company Evotec in order to develop beta cell-modulating diabetes therapies.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • BIOTECH PHARMACON (N)16.80 NOK17.07%
  • ALMIRALL (E)17.26 EUR4.61%
  • EUROFINS SCIENTIFIC (F)301.96 EUR4.16%

FLOP

  • BIOTIE THERAPEUTICS (FI)0.20 EUR-9.09%
  • DBV TECHNOLOGIES (F)67.75 EUR-7.57%
  • CO.DON (D)2.50 EUR-7.41%

TOP

  • KARO BIO (S)39.30 SEK2371.7%
  • BIOTECH PHARMACON (N)16.80 NOK77.8%
  • TRANSGENE (F)4.92 EUR71.4%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-50.0%
  • THROMBOGENICS (B)2.86 EUR-43.3%
  • NEUROVIVE PHARMACEUTICAL AB (S)13.00 SEK-41.2%

TOP

  • KARO BIO (S)39.30 SEK4692.7%
  • ADOCIA (F)82.29 EUR384.9%
  • VERONA PHARMA (UK)5.00 GBP316.7%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-85.7%
  • EVOCUTIS (UK)0.18 GBP-81.2%
  • NEUROVIVE PHARMACEUTICAL AB (S)13.00 SEK-80.1%

No liability assumed, Date: 01.09.2015