Xenon Pharmaceuticals Inc.’s Kv7 potassium channel opener XEN-1101 remains very much alive despite the primary endpoint miss in top-line data from the phase II proof-of-concept X-Nova trial in moderate to severe major depressive disorder. Read More
Partners Regeneron Pharmaceuticals Inc. and Sanofi SA will file a supplemental BLA by year-end for Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD) after interim data from a second phase III trial confirmed – even bested – data from the first, demonstrating a reduction in exacerbations by 34% and improved lung function in patients with uncontrolled COPD and evidence of type 2 inflammation. Read More
GSK plc is looking at a comeback for Blenrep (belantamab mafodotin) as an interim efficacy analysis brought the company good news. Almost exactly a year ago, phase III confirmatory study data for the already-approved multiple myeloma drug fell short of the U.S. FDA’s accelerated approval requirements, so the agency asked GSK to take the drug off the market for the indication. Read More
With U.S. drug prices a perennial issue, several lawmakers, both Democrats and Republicans, are increasingly looking beyond biopharma to identify other “persons of interest” that may be complicit in the high list prices facing American patients. Read More
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Cellcentric, CNS, Entrada, Fluoguide, Index, Ingeneron, Innovent. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adhera, Aeglea, Akiram, Biodexa, GSK, Melior, RVL, Seelos, Scisparc, Sosei, Theseus, Xbrane. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aardvark, Anheart, Merz, Sumitomo. Read More
