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.
26.08.2016 Adocia said it would discontinue its diabetic foot ulcer programme after its lead product BioChaperone PDGF disappointed in Phase III. The French company will turn the focus on its earlier-stage products.
24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.
23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.
19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.
17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).
15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).
09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.
08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.
FILTRODISC™ BIO SD is a filtration system which removes particles (e.g. cells, bacteria, yeast), impurities (e.g. HCP, DNA) and other turbid matter from process liquids (e.g. fermentation broths). more