Entries by Thomas Gabrielczyk

CHMP candidate check

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the results of its September meeting.

EMA rejects Santhera’s DMD drug

The European Medicine Agency’s CHMP has rejected a type II extension application to Santhera Pharmaceutical’s coenzyme Q10 analogon idebenone (Raxone) as treatment for patients with Duchenne muscular dystrophy (DMD). Raxone was approved under exceptional circucumstances in September 2015 to treat visual impairment in patients with the rare eye disease LHON.

Sophia Genetics raises US$30m

Artificial intelligence (AI) specialist Sophia Genetics SA (St. Sulpice, Switzerland) raised US$30m in a series D round to foster global expansion of its cancer diagnostics annotation platform SOPHiA AI.

MS: Gut microbobes drive inflammation

Two research team independently report they have identified specific microbes in the gut of mice and of treatment-naive patients with multiple sclerosis (MS) regulating immune responses. Phase I trails with fecal microbial transplants (FMT) are scheduled to begin early next year.

Life Sciences majors expand digital cancer analytics

Thermo Fisher Scientific has extended its Next Generation Sequencing Companion Dx Center of Excellence Programme (COEP) in Europe. The next-generation sequencing (NGS) provider added a second agreement with the Institute of Pathology Heidelberg (IPH) to its growing COEP portfolio. On the same day, Merck KGaA announced it will partner with Project Data Sphere LLC to jointly lead the Global Oncology Big Data Alliance (GOBDA). 

Nova challenges EU’s „tank or table paradigm

A comprehensive sustainability assessment carried out by nova-Institute shows that first and second generation bioethanol is feasible for the EU’s climate strategy. The study challenges the politically hyped "tank or table" paradigm that valued biofuels unsustainable due to competition to food production.

Bright future for biomanufacturers

Progress in process engineering and media optimisation has resulted in significant productivity increases in upstream processing driving transformations at drug developers and CDMOs. At BPI Europe in Amsterdam, companies showed strategies and product launches pinpointing the way towards what could become a new industry paradigm: continuous processing and flexible modular production plants, which both address changed production needs.

Immunooncology: Roche presents blood biomarker test

Roche is trying to offer a solution for patient selection in immunooncology. At the ESMO congress in Madrid, the theranostics company presented a liquid biopsy test that measures the tumour mutational burden in order to predict the probability  for response to immunotherapy.

‘Adrenaline’ of the immune system discovered

Portuguese and Swiss scientists have discovered that neurons located at mucosal tissues can immediately detect an infection in the organism, promptly producing a substance that acts as an "adrenaline rush" for immune cells.