German PEI limits use of daclizumabFollowing 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. more ➔
Microbiome shows COPD subtypesGerman researchers have found that the lung microbiome is indicative for different subtypes of chronic obstructive pulmonary disease (COPD). more ➔
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. more ➔
ODAC greenlights Novartis’ CAR-T cel...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) … more ➔
Enterome and Nestlé form JVFrench 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 … more ➔
Bavaria and Germany push digital medicine As part of a €5bn investment by 2025, the Free State of Bavaria will kick off two ambitious digital medicine projects next year, government officials said at the Forum Science & Health.   … more ➔
FMI to launch digital oncology service at...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 … more ➔
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 medicin … more ➔
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 more ➔
Success for individualised cancer vaccineGerman biotech company Biontech AG has published positive clinical results for its individualised cancer vaccine Ivac mutanome in patients with late-stage melanoma. more ➔
