Pharma Business International

The U.S. Food and Drug Administration (FDA) has approved Soleno Therapeutics’ VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS).

The US Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors.

The US Food and Drug Administration (FDA) has approved GSK’s Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio.

AstraZeneca is to invest $2.5 billion in Beijing to establish its sixth global strategic R&D centre together with major research and manufacturing agreements that will further advance life sciences in China. This investment over the next five years is part of a strategic partnership with the Beijing Municipal Government and the Beijing Economic-Technological Development Area Administrative Office and includes agreements with three biotechs; Harbour BioMed, Syneron Bio, and BioKangtai.

The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. The approval in Japan was based on data from the landmark BOREAS phase 3 study.

The Japan Ministry of Health, Labour and Welfare has approved Genmab’s TIVDAK (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. TIVDAK is the first and only ADC to be approved for people living with cervical cancer in Japan. In recent years, cervical cancer incidence and mortality rates have increased in Japan, particularly among women under age 50.

Chiesi Group, a global biopharmaceutical company headquartered in Parma, Italy, has made a major investment in Nerviano (Milan, Italy), with the construction of a new facility for the production of its therapeutic solutions. The project entails the revitalization of this historical production site, first established in 1965 as an oncology research centre for Farmitalia Carlo Erba and subsequently subjected to several ownership changes, until its closure in 2024.

The return on investment in pharma research and development (R&D) has increased from the previous year, with GLP-1 drugs helping to boost growth, according to analysis by Deloitte. Findings from the latest Measuring the Return from Pharmaceutical Innovation, an annual report which analyses the late-stage drug development pipelines of the top 20 global biopharma companies, reveals an increase in the forecast internal rate of return (IRR) from 4.3% in 2023 to 5.9% in 2024.

The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the potential of the vaccine candidate to address a serious condition and address an unmet public health need. The chlamydia vaccine candidate has been designed to protect against primary genital tract infection and reinfection by the bacterium Chlamydia trachomatis.

Augustine Therapeutics, a biotechnology company focused on developing new therapies for neuromuscular, neurodegenerative and cardio-metabolic diseases through the inhibition of the cytosolic Histone DeACetylase 6 (HDAC6) enzyme, has completed its Series A financing round raising a total of €77.7 million.