News

Drug developers deeply concerned
Enlarge image

PolicyEUUK

Drug developers deeply concerned

28.11.2013 - EU industry associations urge EU legislators: Don’t make the regulatory process too long, putting Europe’s competitiveness at risk.

Just before Christmas, the European Commission, European Parliament and the EU Council are expected to finalise the Clinical Trials Regulation. However, drug developers and manufacturers are deeply concerned. They believe that the  compromise could fail to meet the original goal of the Regulation which was to reverse decreasing numbers of clinical trials carried out in the bloc.

In a joint statement EuropaBio, the European Federation of Pharma Industry Associations (EFPIA), the Association of Clinical Research Organisations (ACRO), Cancer Research UK, and the Patients Network for Medical Research and Health (EGAN) have urged the legislators not to dilute the original aim of the regulation:  "It is imperative to build on Europe’s innovative edge – not just for competitive reasons, but because innovation is the tool needed to deliver new and improved medicines to patients,“ they stress.  "The longer the regulatory process takes to approve a clinical trial, or process regulatory procedures around it, the greater the cost of the trial. Higher costs can result in fewer trials being run, reducing our ability to understand treatments better. Towards this end, we strongly support the path set out by the Commission as well as the European Parliament in ensuring competitive timelines for these authorisations, and urges the Council to support this approach moving forward.“

The associations say it is essential to ensure that timelines are predictable and are in no case longer than the timelines already established in the current Directive. The proposal of the Commission initially intended to shorten the Clinical Trial Authorisation Timeline from 60 days (90 days for advanced therapy medicinal products such as gene and cell therapies) to 25 days (plus 5 extra days for ATMPs). However as there are member states where the timeline is significantly longer, industry fears that the Council will prolong the timeline. According to EuropaBio "everything going beyond 60 days would clearly be uncompetitive and send the wrong signal“. 

Short timelines at high quality level, however, are possible. In the UK, the initial assessment is performed within 30 days, according to the MHRA. Applications for Healthy Volunteer Trials and sponsor-determined Phase I trials in non-oncology patients will be assessed and processed within 30 days, with an average of 14 days or less.

eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-04/eu-biopharma-industry-concerned.html

BusinessUKSwitzerland

29.07.2015 Newly founded Mereo BioPharma has acquired three mid-stage clinical assets from Novartis. In turn, the Swiss pharma concern will hold a stake in the UK company. Other investors are also on board.

M&AIreland

28.07.2015 Irish Allergan is bolstering its product pipeline with a takeover of CNS specialist Naurex. At the same time, the company is divesting its global generics business to Teva.

Public marketGermanyFranceBelgiumFinlandDenmarkUK

24.07.2015 Biotech companies across Europe continue to raise cash on the public markets, generating €3bn in total financing proceedings in the first half of 2015. Compared to 2014, this is almost twice as much.

FinanceFrance

23.07.2015 US money keeps flowing into Europe's biotechs. As the race for the peanut allergy market heats up, NASDAQ listed French biotech DBV has announced the successful closing of US$281m (€256m) share offering for its allergy products.

BioplasticsFrance

21.07.2015 French biotech Deinove has launched a R&D programme to produce the versatile chemical intermediate muconic acid by using a designer variant of the Deinococcus bacteria.

BusinessFrance

16.07.2015 Sanofi has announced plans to restructure its business in five standalone global business units starting in January 2016. The goal is to promote growth and help the company launch a catalogue of new drugs over the next five years.

R&DUK

15.07.2015 GlaxoSmithKline (GSK) has become the first drugmaker to join the Francis Crick Institute. It is a consortium made up of six scientific and academic institutes to conduct research and drug development in the UK. The new institute is set to become a world-leading centre of biomedical research and innovation.

FundingUK

13.07.2015 UK drug developer ReNeuron has pulled in £68.4m (€96m) for its cell therapy pipeline for stroke and blindness treatments. Biotech guru Neil Woodford increases his fund’s stake in ReNeuron.

BusinessSweden

10.07.2015 Karolinska Development has slashed the reported value of its portfolio by almost half by revising its valuation model for early stage companies and divesting its shares in pain med maker Pharmanest.

M&AIreland

08.07.2015 Horizon Pharma plc. has set its sights on US-American speciality pharma company Depomed Inc. After getting nowhere with the rival’s board, Horizon has now launched a US$3bn hostile bid for the pain and CNS specialist.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • DIAMYD MEDICAL -B- (S)9.85 SEK15.20%
  • ZEALAND PHARMA (DK)158.00 DKK12.86%
  • ERYTECH PHARMA (F)36.51 EUR6.13%

FLOP

  • FLAMEL TECHNOLOGIES (F)23.00 USD-10.47%
  • ZELTIA (E)3.69 EUR-8.44%
  • WILEX (D)3.28 EUR-6.29%

TOP

  • IXICO (UK)35.00 GBP55.6%
  • DBV TECHNOLOGIES (F)79.73 EUR53.7%
  • ZEALAND PHARMA (DK)158.00 DKK43.0%

FLOP

  • BIOTEST (D)25.73 EUR-63.2%
  • CHRONTECH PHARMA (S)0.01 SEK-50.0%
  • BIOTECH PHARMACON (N)9.47 NOK-44.9%

TOP

  • ADOCIA (F)90.49 EUR556.2%
  • FORMYCON (D)28.68 EUR318.7%
  • DBV TECHNOLOGIES (F)79.73 EUR305.5%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-88.9%
  • NEOVACS (F)1.02 EUR-70.9%
  • NEUROVIVE PHARMACEUTICAL AB (S)22.00 SEK-68.6%

No liability assumed, Date: 29.07.2015