Inventiva SA has halted enrollment in its pivotal phase III Nativ3 trial with nonalcoholic steatohepatitis (NASH) candidate lanifibranor after a patient experienced raised liver enzymes indicative of autoimmune hepatitis. The resulting delays to the study could spell trouble for the firm, which estimates its cash runway will only see it through to the start of the third quarter 2024.
Venture capital (VC) firm TVM Capital Life Science recently co-led a $16 million series A financing for Vektor Medical Inc., which has developed an AI-based tool that identifies potential arrhythmia source locations. The funding is part of TVM’s strategy of investing in med-tech companies which have no development risk and offer an exit opportunity in under four years.
Body: The U.K.’s Medicines and Health Care Products Regulatory Agency (MHRA) has a program designed to facilitate more rapid market access for medical devices of urgent need, and now the agency has put money into the policy.
The European Commission approved two therapies for progressive, genetic diseases: Biogen Inc.’s Friedreich’s ataxia drug, Skyclarys (omaveloxolone), and Crispr Therapeutics AG’s CRISPR/Cas9 gene therapy for sickle cell disease and transfusion-dependent beta-thalassemia, Casgevy (exagamglogene autotemcel, exa-cel).
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
Medicxi is spinning six of its early stage companies into an immuno-dermatology specialist and turbocharging development with a $100 million seed round.
Toku Inc. recently obtained CE and UKCA marks for its artificial intelligence (AI) technology, Clair, which evaluates the risk of cardiovascular disease (CVD) using retinal images captured during an eye exam.
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.
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