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EMA to make Phase I safer
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EMA to make Phase I safer

31.05.2016 - The European Medicines Agency (EMA) means to increase first-in-man trial safety. Following the death of a volunteer in a Phase I trial earlier this year, the European Medicines Agency has started a review of the guidelines for first-in-man studies.

In an EU-wide review on the first-in-human clinical trial guidelines, the EMA plans to identify any areas that will need revision following the death of a man participating in a trial in Rennes, France earlier this year. In January, the trial for a drug developed by Portuguese pharma company Bial, carried out by French CRO Biotrial, resulted in the death of one of the volunteers, and neurological damage – likely long-term in five others (http://www.european-biotechnology-news.com/news/news/2016-01/death-in-phase-i.html). Biotrial came under fire by investigators for “major shortcomings”. While a final report commissioned by the French Agency for the Safety of Health Products (ANSM) states that the death was probably caused by the drug’s toxicity and not by any violation of the rules, the authors did criticise a lack of common sense in the proceedings and recommended changes to the regulations and international best practice.

The EMA draws on the report by ANSM as well as another in-depth investigation by the Inspection générale des affaires sociales (IGAS), the inspectorate for social affairs in France. Both reports include a series of recommendations regarding the requirements for authorisation and conduct of first-in-human clinical trials for further examination by the international regulatory and public health community. By July, a concept paper identifying areas for change and proposals to minimalise risk in trials such as the one in Rennes. The concept paper will form the basis for an EU-wide review of the guidelines. This process will include targeted discussions with stakeholders and a public consultation on proposed changes later in 2016.

© european-biotechnology-news.com/um

http://www.european-biotechnology-news.com/news/news/2016-02/ema-more-safety-in-phase-1.html

AwardFinlandEU

27.05.2016 The Finnish Technology Academy has awarded US-American innovator Frances Arnold the 2016 Millennium Technology Prize, worth €1m. Arnold is a pioneer in the field of directed evolution.

OncologyUK

26.05.2016 BigDNA relaunches as Iceni Pharmaceuticals with the aim to develop repurposed and reformulated cancer therapies. First order of business: repurpose Merck Serono’s cilengitide as a multiple myeloma treatment.

MicrobiomeFranceDenmarkEU

24.05.2016 One of the pioneering companies developing pharmaceuticals and diagnostics based on the gut microbiome, Enterome Bioscience, has raised €14.5m in a Series C financing round. Among the investors were Seventure and Lundbeckfond as well as Nestlé.

AntibioticsEUUKItaly

20.05.2016 The long awaited global review on antimicrobial resistance by economist Lord Jim O’Neill has been published. It sets out an action plan to defeat superbugs with a huge awareness campaign and rapid diagnostics to be used before antibiotics are prescribed.

LicensingGermanyIrelandSwitzerland

18.05.2016 Bayer is deepening its involvement in CRISPR with a licensing agreement for genome editing patents. Irish partner ERS Genomics holds the rights to the CRISPR/Cas9 tech from Emmanuelle Charpentier, one of the inventors.

M&AGermany

17.05.2016 Newly rebranded Siemens Healthcare has entered the field of molecular testing for cancers with the acquisition of Cologne-based NEO New Oncology.

FinancingUK

11.05.2016 Newly spun out company OxStem has raised £16.9m (€21.5m) to develop regenerative meds for the treatment of age-related disease. It is the largest financing for an Oxford spin-out – or any UK academic spin-out – to date.

FinancingSwitzerland

09.05.2016 Swiss Genentech partner AC Immune has raised CHF42.7m (€38.6m) in order to advance its therapeutic and diagnostic product pipeline in Alzheimer’s disease. The news follows a recently announced R&D collaboration with Biogen.

FinancingSpain

04.05.2016 Barcelona-based epigenetics expert Oryzon Genomics has closed a debt funding round of €10.5m, bringing the total money raised since last year to €27m. The funds will serve to advance the company’s two LSD1 inhibitors in cancer and neurodegeneration.

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No liability assumed, Date: 30.05.2016