Entries by Thomas Gabrielczyk

UK invests £86m in healthcare SMEs

The UK government has set up a new fund to support medical innovation. Breakthrough innovations that have the potential to benefit the NHS will also undergo accelerated access review aimed at speeding up access to novel medicines. 

German PEI limits use of daclizumab

Following a safety warning of the EMA on deaths related to Biogen’s multiple scleroisis (MS) drug Zinbryta (daclizumab), German regulatory authority has issued a red hand letter.

Psoriasis: FDA approves guselkumab

The Food and Drug Administration has granted US market approval to Janssen Biotech/MorphoSys’ IL23 blocker guselkumab (Temfya) as therapy for moderate to severe psoriasis.

ODAC greenlights Novartis’ CAR-T cell therapy CTL019

Swiss Novartis is about to receive the very first market approval (BLA) for a CAR-T cell cancer therapy globally. The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of CTL019 (tisagenlecleucel) for the treatment of the orphan B-cell blood cancer ALL.

Enterome and Nestlé form JV

French gut microbiome analysis specialist Enterome Bioscience SA and therapeutic nutrition company Nestlé Health Science have formed a 50:50 joint venture aimed at developing microbiome-based diagnostics for certain common diseases. 

FMI to launch digital oncology service at Roche site

At the opening ceremony for R&D, training and production buildings at Roche Penzberg, the Pharma giant said that Foundation Medicine (FMI) will establish a digital oncology service at the site offering oncologists across Europe decision support in personalised medicine.

Biocartis inks breast cancer R&D deal

Belgian diagnostics company Biocartis Group NV and Singpore’s A*STAR ETPL have kicked off development of a multimodal breast cancer assay designed to guide therapy selection in personalised medicine.

4SC AG raises €41m

Small molecule cancer drug developer 4SC AG (Planegg-Martinsried, Germany) has completed a capital increase fueling development of its clinical programmes for resminostat, 4SC-202 and 4SC-208