Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.
Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Success in Japan may further bolster Protara Therapeutics Inc. in its push with TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), for which the New York-based firm disclosed interim results from an ongoing phase II trial.
Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.
Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld.
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