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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. 

© Biogen

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). 

© Janssen Biotech

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.

FDA building, © FDA

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.

Excess of Bacteroides species in the microbiome are an indicator for enhanced responsivess to CTLA4 checkpoint inhibitors such as BMS' ipilimumab.

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. 

© Bayer AG

Bayer has always been extremely supportive of the new Unitary Patent System (UPS) and has been one of the driving forces behind it within the German industry. However, the company will not be putting its full portfolio through the UPS and the Unified Patent Court (UPC).

© Bio-M Biotech Cluster Development GmbH

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.  

VIPs at Roche's ceremony (from left to right): 
Digital infrastructure minister Alexander Dobrindt, Dr. Ursula Redeker, spokesperson of the Executive Board at Roche Diagnostics, Dr. Christoph Franz, Chairman of the Administrative Board, Roche AG, Ilse Aigner, Bavarian Minister of Economic Affairs; and Media, Energy and Technology, Dr. Hagen Pfundner, CEO, Roche Pharma AG, Germany, Jens Spahn, State Secretary at the Federal Ministry of Finance, © Roche Diagnostics

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.