Takeda’s Orzeyful secured Japan MHLW approval for narcolepsy type 1

The trial will evaluate visugromab in conjunction with nivolumab and lenvatinib. Credit: DW2630 / Shutterstock.com. Takeda has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orzeyful (oveporexton) to treat narcolepsy type 1 in adults. This decision makes Orzeyful the only treatment in Japan currently indicated to address the underlying cause of … Read more

FDA places clinical hold on REGENXBIO’s RGX-121 in MPS II trial

REGENXBIO and NS Pharma are reviewing imaging and data and will decide RGX-121’s next steps after receiving FDA’s letter. Credit: Max Acronym / Shutterstock.com. REGENXBIO has reported that the US Food and Drug Administration (FDA) has placed a clinical hold on its investigational gene therapy, RGX-121 (clemidsogene lanparvovec), developed for the treatment of mucopolysaccharidosis type … Read more

IceCure and Scovas agree for ProSense distribution in Netherlands

IceCure’s ProSense is intended for breast cancer and interventional oncology. Credit: Gorodenkoff / Shutterstock.com. IceCure Medical has signed an exclusive distribution agreement with Scovas Medical for its ProSense cryoablation systems in the Netherlands. The agreement will see Scovas Medical become the sole distributor for IceCure Medical’s ProSense in the country, for breast cancer and interventional … Read more

McKesson to buy Precision Medicine Group for $2.25bn

Precision Medicine Group will operate within McKesson once the transaction receives final regulatory and closing approvals. Credit: Piotr Swat / Shutterstock.com. US-based healthcare services provider McKesson has agreed to buy Precision Medicine Group for $2.25bn. McKesson believes that the deal will support its clinical research and biopharmaceutical commercialisation services. Discover B2B Marketing That Performs Combine … Read more

Patient enrolment concludes in Senhwa’s Phase Ib trial of pidnarulex

Senhwa develops cancer therapies and advances a pipeline with CX-5461, CX-4945 for solid tumours and haematological malignancies. Credit: Sai Thaw Kyar / Shutterstock.com. Senhwa Biosciences has completed enrolment in its Phase Ib expansion trial of pidnarulex (CX-5461) as a monotherapy for people with advanced solid tumours carrying breast cancer gene 1/2 (BRCA1/2) or partner and … Read more

Axoft launches Fleuron WISE polymer for advanced biological imaging

WISE is permeable to O₂ and CO₂, compatible with harsh solvents, and capable of ultra-low small-molecule sorption. Credit: Axoft / Business Wire. US-based neurotechnology company Axoft has rolled out Fleuron Water Invisible Soft Elastomer (WISE), a polymer developed to minimise optical distortions during high-resolution imaging of aqueous biological samples. The new ultraviolet (UV)-curable material is … Read more

ViiV Healthcare’s Tivicay PD gains FDA approval for paediatric HIV therapy

Around 89% of eligible participants completed the therapy through week 140. Credit: Gorodenkoff / Shutterstock.com. The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir), for use with other antiretroviral agents in paediatric patients with human immunodeficiency virus type 1 (HIV-1) who weigh at least 2kg. The therapy is indicated for … Read more

HaemaLogiX doses first patient with KMCAR T-cell in KOALA trial

Multiple myeloma is a form of blood cancer involving abnormal proliferation of plasma cells in bone marrow. Credit: Hadayeva Sviatlana/Shutterstock.com. HaemaLogiX has treated the first patient with its KMCAR T-cell therapy as part of the Phase I KOALA clinical trial for relapsed or refractory kappa-restricted multiple myeloma. The trial is being conducted at the Peter … Read more

PENTAX broadens MAGENTIQ EYE partnership for global AI colonoscopy

The agreement integrates MAGENTIQ-COLO, MAGENTIQ EYE’s AI system for colonoscopy, into PENTAX Medical’s video processors. Credit: Peter Porrini/Shutterstock.com. Japan-based PENTAX Medical, part of the HOYA Group, has expanded its collaboration with MAGENTIQ EYE to increase global adoption of AI-assisted colonoscopy. The partnership, initially focused on the US, will cover Europe, the Middle East and Africa, … Read more

FDA to review Kowa Pharmaceuticals’ NDA for glaucoma eye drop K-911

K-911 is being developed as a topical ophthalmic monotherapy formulated as a sterile solution. Credit: Gorodenkoff / Shutterstock.com. The US Food and Drug Administration (FDA) is set to review Kowa Pharmaceuticals America’s new drug application (NDA) for K-911, an investigational once-daily eye drop aimed at reducing intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular … Read more