Members of the General Court of the European Union © CVEU

The European Medicines Agency (EMA) has won a landmark battle about the amount of data from clinical dossiers that may be made public. The European Court of Justics (EJC) rejected the demand of three drug developers not to publish what they called confidential information under the EMA’s transparency rules. 

© Selvita SA

Selvita S.A., a clinical stage drug discovery and development company focused on innovative medicines for oncology patients and drug discovery services, announced today the appointment of Steffen Heeger, M.D., PhD, to the role of Chief Medical Officer.

© Kinderhilfswerk

Global health product development partnership FIND (Foundation for Innovative New Diagnostics) has announced four major diagnostics projects to combat antimicrobial resistance (AMR) in resource-poor settings. 

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In mid-November, the European Commission tabled the long-awaited review of its Bioeconomy Strategy and Action Plan. European Biotechnology spoke with Waldemar Kütt, Head of Unit Bioeconomy Strategy, about the development the bioeconomy has made since its launch in 2012 by the European Commission and the instruments needed to attract investments, make it circular, and create a stable policy environment for companies and investors.

A brand-new survey conducted by auditing and consulting firm PwC and Strategy& has found out that 80% of data protection-prone Germans would share their data in case of being diagnosed with cancer. The results show that cancer could act as a gate-opener to approaches in personalised medicine that depend on the accessiblity of patient data.

US and Dutch researchers have found that carcinogenic E. coli and B. fragilis versions in the gut of patients who developed precancerous polyps early in life trigger development of colon cancer by secreting proinflammatoy signals, depleting mucus and inducing DNA damage.

Using CRISPR-Cas 9 genome editing, US and German stem cell researchers have corrected clustered mutations in the dystrophin gene in heart mucle cells obtained from induced pluripotent stem cells of patients with Duchenne muscular dystrophy (DMD).

©Rentschler Biopharma SE

Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, today appointed Dr. Ralf Otto as Chief Operating Officer (COO), effective February 1, 2018.

Following critisism from the industry, the European Patent Office has drafted a proposal to allow exemptions to its Early Certainty Initiative. Industry associations had pressed the EPO not to limit the time to grant a patent to 12 months arguing it would have detrimental effects on the life sciences sector.

EU ombudsman Emily O' Reilly sees no indication of conflict of interest with the EMA's panel members who assessed the AEs relating to pediatric cervical cancer vaccines. (picture ©European Parliament/Alexis Haulat)

A complaint against the EMA’s handling of a referral procedure related to potential side effects of Sanofi/MSD’s HPV vaccine Gardasil and GSK’s HPV jab Cervarix, filed by the Nordic Cochrane Centre and physicians, has been rejected by the European Ombudsman.