The European Medicines Agency accepted the marketing application for filgotinib, a Janus kinase 1 inhibitor developed jointly by Gilead Sciences and Galapagos as a treatment for rheumatoid arthritis, and the treatment will be co-commercialized by the companies in the UK, France, Germany, Spain and Italy, with Galapagos retaining its exclusive rights in Belgium, Luxembourg and the Netherlands. The collaborators plan to file a New Drug Application with the FDA by the end of the year.
Biopharmaceutical firm SpringWorks Therapeutics is advancing plans for its initial public offering with the filing of a preliminary prospectus as it hopes to raise $115 million. SpringWorks develops and commercializes precision medicine treatment for cancer and rare diseases.
Generex Biotechnology announced plans for a possible reverse merger as it prepares to spin out NuGenerex Immuno-Oncology, its subsidiary, but has not disclosed the name of the company since they are in the final stage of negotiations.
A preliminary prospectus was filed by Satsuma Pharmaceuticals, a developer of migraine therapies, for an initial public offering worth $86 million.
Roche's Hemlibra, or emicizumab, was found to be superior as a preventive treatment compared to factor VIII replacement therapy to reduce bleeding rates among patients with hemophilia A without inhibitors. Details of the study were reported in the journal Current Medical Research and Opinion.
The government of South Australia plans to lift the moratorium on biotech crops starting 2020, except for Kangaroo Island, based on the recommendations of an independent reviewer. Ending the long-term ban on biotech crops will give mainland farmers the option to plant biotech crops for the first time since 2003.
A slight increase in the production volume of sugarcane-derived ethanol was announced by Brazil's sugarcane industry association UNICA. Ethanol production reached 2.65 billion liters in the last two weeks of July, compared with 2.62 billion liters during that period in 2018.
The FDA has granted approval to CVRx's Barostim Neo System, an implanted cardiac neuromodulator that provides baroreflex stimulation in patients with advanced heart failure who are not suitable for cardiac resynchronization therapy and other heart failure devices.
Jocelyn Silvester, director of research for Children's Hospital Boston's celiac disease program, received a two-year grant of up to $160,000 from research foundation Beyond Celiac. The funds will be used for transcriptomic analysis of intestinal biopsies to identify RNA biomarkers associated with gluten-related inflammation.
Roche's Foundation Medicine subsidiary plans to file for FDA approval of its FoundationOne CDx assay as a companion diagnostic for Genentech's Rozlytrek, or entrectinib. Rozlytrek is approved for adult patients with ROS1-positive metastatic non-small cell lung cancer and for adults and adolescents whose cancers have NTRK gene fusions and who have no other treatment option.
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