The Belgian academic Stefan De Wachter is seeking patent protection for methods of ensuring pelvic health and treating a disease or disorder characterized by a dysfunctional autonomic nervous system using neuromodulation and applying a burst stimulation pattern of electric pulses of high frequencies from electrodes located in the proximity of the sacral plexus and/or pelvic plexus.
Redx Pharma plc has closed its biggest transaction to date, selling a preclinical KRAS inhibitor program to Jazz Pharmaceuticals plc in a potential $880 million deal. Of that, $10 million will be paid up front, with the balance to come in development and commercialization milestones. For any product that makes it to market, Redx will in addition receive tiered mid-single digit percentage royalties.
Theryq SAS and Gustave Roussy, a European center for cancer research, were given €38 million (US$40.1 million) in funding by Bpifrance, the French public sector investment bank, to further develop Flashdeep, a flash radiotherapy device that uses extremely high energy electron (VHEE) radiation to treat cancers that are resistant to traditional treatments.
The European Union (EU) is steadily making progress on the Artificial Intelligence Act (AI Act), landmark legislation that will affect AI not just for medical uses, but for all uses across the EU economy.
The controversy over the use of paclitaxel (PTX) in devices used to treat peripheral artery disease (PAD) has taken roughly half a decade to unwind as regulatory agencies across the globe stand down their restrictions on the use of these devices.
Trinity Biotech plc. paid $12.5 million to acquire Waveform Technologies Inc.’s biosensor and continuous glucose monitoring (CGM) assets. It also formed a partnership with Bayer AG to launch a CGM biosensor in China and India. These moves are part of Trinity’s transformation strategy to become a leading player in wearable biosensor technology.
The EU’s proposed update of its pharmaceutical legislation will break the model of small companies acting as the vehicle for translating Europe’s rich research base for onward development by pharma, according to an analysis looking specifically at the impact the new rules would have on the biotech sector.
In its first patenting, Cambridge, U.K.-based Opto Biosystems Ltd. is seeking protection for implantable sensors that may be used in systems to measure chemical, biological, or electrical signals in the central and/or peripheral nervous systems.
After almost 10 years on the market, the EMA is to withdraw its conditional approval of the Duchenne muscular dystrophy treatment Translarna (ataluren), after concluding there is still not enough evidence of its effectiveness.
To date, developers of digital health technologies have had little luck with coverage and reimbursement, but the picture is slowly improving. The U.K.’s National Institute for Health and Care Excellence (NICE) has endorsed two artificial intelligence (AI) algorithms for diagnosis of stroke, although this is limited to an evidence generation framework that puts the sponsors on the hook for generating the data that will allow unlimited use in the U.K.’s trusts.