UCB SA anticipates submitting regulatory applications in the third quarter for IL-17-targeting bimekizumab in psoriatic arthritis and ankylosing spondylitis, after chalking up second successful phase III trials in both indications. Meanwhile, the high commercial hopes for the would-be blockbuster remain at least temporarily deferred as pandemic-related travel restrictions have delayed FDA action on the BLA for plaque psoriasis. Read More
Administering multiple booster doses against COVID-19 is not sustainable in the longer term, international drug regulators said during a meeting of the International Coalition of Medicines Regulatory Authorities, held Jan. 12. Regulators argued that a long-term strategy should involve vaccines capable of tackling several variants at once, not just omicron, and that tweaking existing vaccines and comparing them with first-generation vaccines using clinical studies is the way forward, according to a report from the meeting. Read More
When, late last year, Daiichi Sankyo Co. Ltd. won breakthrough status from the FDA for HER3-targeting lung cancer prospect patritumab deruxtecan, Wall Street began taking stock of other candidates in the space. “The winning strategy to therapeutically target HER3 remains to be seen,” noted a recent paper in Clinical Cancer Research, “but HER3 is a promising drug target, and the era of drugging the ‘undruggables’ has already started.” Read More
Destroying senescent cells in the aging stem cell niche, either genetically or pharmacologically using the small-molecule senolytic ABT-263 (navitoclax; Abbvie Inc.), enhanced hippocampal neurogenesis and cognitive function in mice, a Canadian study led by scientists at the University of Toronto has found. Read More
Innovent Biologics Inc. has secured an option to license China rights for up to three enzyme specific inhibitors for inflammatory disorders with few or no treatments from Amagma Therapeutics Inc. Innovent will also manufacture the inhibitors for a phase II trial in the region. Read More
New and updated preclinical and clinical data presented by biopharma firms at the ASCO Gastrointestinal Cancers Symposium, including: Abivax, Astrazeneca, Cardiff, Chimerix, Exelixis, Immunitybio, ITM, Leap, Merck, Seagen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzinova, MD Anderson, Orchard, Revivicor, Sorrento, Tevogen, Trisalus, United Therapeutics, Yingli. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Amgen, AN2, Aptorum, Argenx, Beigene, Betterlife, Clairvoyant, Compass, Idorsia, Jeil, Marker, Novavax, Nuvation, Omeros, Opko, Palleon, Pfizer, Rockwell, Senhwa, Turning Point. Read More
