Entries by Thomas Gabrielczyk

Roche does not have to pay US$685m fine

The European Commission has closed its very first infringement procedure under the Penalty Regulation. During an inspection at Roche’s 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

Hadean 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

The European Medicines Agency’s 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.

reMYND in €350m diabetes deal with Novo

Belgian 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

A 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.