Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.
Akeso Pharmaceuticals Inc.’s gumokimab (AK-111) and manfidokimab met all primary efficacy endpoints in its phase III trials in active ankylosing spondylitis and in moderate to severe atopic dermatitis, respectively.
French vaccines specialist Osivax SAS has been awarded $19.5 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund work on its universal influenza A vaccine.
The frontiers of xenotransplantation have been further extended with a pig-to-human lung transplant, the first time an organ that is directly exposed to the external environment – with the associated risk of respiratory pathogens – has been transplanted. The genetically modified pig lung remained viable and functional for nine days, after it was transplanted into a 39-year-old man who was declared brain dead following a hemorrhagic stroke.
Showing similar results as the first phase III trial completed in 2022, Nicox SA’s nitric oxide-donating bimatoprost eye drop, NCX-470, met the primary endpoint in the phase III Denali trial for open-angle glaucoma or ocular hypertension, clearing the way for regulatory filings in both the U.S. and China.
Quantumpharm Inc., known as Xtalpi Inc., announced receiving $51 million up front from a potential $5.99 billion deal with Dovetree LLC on Aug. 6. The collaboration, first inked through a letter of intent between the two parties on June 23, will combine Shenzhen, China-based Xtalpi’s AI-based and robotics-driven discovery platform with Dovetree’s “biological insights.” The goal will be to select and validate potential first-in-class candidates for Dovetree across five areas of oncology, immunology and inflammatory diseases, neurological disorders and metabolic dysregulation.
Minghui Pharmaceutical Ltd. announced it is raising $131 million in a pre-IPO financing round Aug. 7. The funds will be used to advance its cancer and inflammatory disease pipeline, which include a PD-1/VEGF bispecific antibody, antibody-drug conjugates (ADCs) and a topical Janus kinase inhibitor.
Innogen Pharmaceutical Group announced an $86 million IPO on the Hong Kong Stock Exchange that will see the company advance its lead product, Diabegone (efsubaglutide alfa), an ultra-long-acting glucagon-like peptide-1 receptor agonist into new global markets for type 2 diabetes as well as other metabolic diseases.
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