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.
German researchers have found that the lung microbiome is indicative for different subtypes of chronic obstructive pulmonary disease (COPD).
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.
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.
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.
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.
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.
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.
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
German biotech company Biontech AG has published positive clinical results for its individualised cancer vaccine Ivac mutanome in patients with late-stage melanoma.