The European Commission has closed its very first infringement procedure under the Penalty Regulation. During an inspection at Roches UK headquarters in 2012 the British MHRA found data on 80,000 not properly reported adverse events of approved Roche meds, 15,161 of which included deaths.
Roche does not have to pay US$685m fine
Latest NewsThe European Commission has closed its very first infringement procedure under the Penalty Regulation. During an inspection at Roches UK headquarters in 2012 the British MHRA found data on 80,000 not properly reported adverse events of approved Roche meds, 15,161 of which included deaths.
A new fund from the north
Latest NewsHadean Ventures announced the launch of Hadean Capital I, a fund that will invest up to € 100 m in life science companies, with a particular focus on the Nordic region.
CHMP recommends EU approval of seven medicines
Latest NewsThe European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval at its December 2017 meeting, including two orphan medicines, and one biosimilar.
Sally Ann Forsyth to join SBC
AppointmentsStevenage Bioscience Catalyst (SBC) has announced that Dr. Sally Ann Forsyth is set to join the company as CEO in March 2018.
reMYND in €350m diabetes deal with Novo
Latest NewsBelgian reMYND N.V. has out licenced worldwide commercialisation rights for its small molecule programme ReS39 in diabetes to Novo Nordisk A/S. The drug impedes death of insulin-producing beta cells by preventing the formation of cytotoxic islet amyloid polypeptide (IAPP) aggregates.
TB urine test outperforms standard of care
Latest NewsA new, non-invasive tuberculosis urine test prevents common disadvantages of the standard tuberculin skin test: Measuring lipoarabinomannan glycan from M. tuberculosis, it detects the active disease in early stage and does not interfere with co-infections or weakened immune system.
LSP raises €280m for late-stage med-tech companies
Latest NewsLife sciences investment group LSP has launched the largest fund in Europe dedicated to late-stage medical technology assets, including diagnostics and digital health.
Aelin Therapeutics NV bags €27m in Series A financing
Latest NewsBelgian start-up company Aelin Therapeutics NV secured the funds to push development of candidate drugs arising from its Pept-in protein knockdown platform, which harnesses protein aggregation to induce functional knockdown of target proteins.
ArgenX reports hints to efficacy of ARGX-113 in generalised myasthenia gravis
Latest NewsDutch llama antibody specialist ArgenX met the safety endpoint in a Phase II trial with ARGX 113 (efgartigimod), a first-in-class antibody that lowers pathogenic levels of IgG, in patients with the autoimmune disease myasthenia gravis.
Ortho markets predictive heart failure re-hospitalisation test
Latest NewsIn vitro diagnostics leader Ortho Clinical Diagnostics (Raritan, US) expands his assay portfolio with Sphingotecs first-in-class biomarker test that predicts residual edema and re-hospitalization in patients with congestive heart failure.