Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.
Kyorin Pharmaceutical Co. Ltd. has out-licensed its preclinical candidate, KRP-M223, and its back-up compounds to Novartis Pharma AG in a deal worth up to $777.5 million. Under the terms, Novartis gains an exclusive worldwide license to develop, manufacture and commercialize Kyorin-discovered KRP-M223.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
To increase diagnosis across Australia, the partnership will see Compumedics Ltd. of Melbourne supply its Somfit devices and electrodes to Philips’ pharmacy-based sleep programs in pharmacies across Australia.
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Cosette Pharmaceuticals Inc. announced plans to acquire Adelaide, Australia-based Mayne Pharma Pty Ltd. for AU$672 million (US$430 million) to grow its women’s health and dermatology franchise in the U.S. Under terms, Cosette, of Bridgewater, N.J., will acquire 100% of Mayne’s shares at AU$7.40 per share in cash. The price represents a 37% premium to Mayne’s closing share price on Feb. 20. The deal is expected to close in the second quarter of 2025.
Qyuns Therapeutics Co. Ltd.’s monoclonal antibody targeting IL-17A, QX-002N, met both primary and secondary endpoints in a phase III trial in ankylosing spondylitis.
