Topic: Clinical Trial Results
Supernus’ two phase 3 studies in children with ADHD hit their primary endpoints but didn’t wow investors worried about established generics.
The major restructuring is intended to keep Merrimack operating and raking in milestones from Ipsen while it looks into strategic alternatives.
FDA proposes heavy fines on pharmaceutical companies and CROs that don’t post clinical trial results online.
Viking Therapeutics’ lead lipid disorder asset met its endpoints in a midstage trial, dropping cholesterol and liver fat levels in patients with NAFLD.
The decision comes a year after the monoclonal antibody, GNbAC1, failed to beat placebo in a phase 2b trial.
The data suggest filgotinib is safe and as effective as JAK rivals including AbbVie’s upadacitinib, setting the stage for a four-way commercial scrap.
BMS’ tyrosine kinase 2 inhibitor checked off a phase 2 psoriasis trial, showing high levels of skin clearance after three months of daily treatment.
Celtaxsys’ cystic fibrosis drug cleared phase 2 by reducing lung exacerbations, such as heavy coughing episodes that can lead to irreversible damage.
Athenex’s ointment cleared 100% of precancerous actinic keratosis lesions within 60 days, including in the face and scalp, in two phase 3 trials.
Pluristem and Thermo Fisher will collaborate to scale up manufacturing of regenerative medicines, to build an industry capable of millions of doses.