New Anglo/U.S. obesity and cardiometabolic specialist Verdiva Bio Ltd. has launched with a massive $411 million series A and a portfolio of GLP-1 and amylin agonists in-licensed from China.
The wheels of the antibody-drug conjugate (ADC) juggernaut keep on turning, with Araris Biotech AG announcing a deal with a headline value of $780 million to apply its multi-payload linker technology to generate novel ADCs for Chugai Pharmaceutical Co. Ltd.
Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.
Roche Holding AG kicked off the new year (again) with a potential $1 billion deal, including $80 million up front, for exclusive rights to Innovent Biologics Inc.’s IBI-3009, a DLL3-targeting antibody-drug conjugate (ADC) candidate that recently entered a phase I study.
The curtain is coming down on one of Europe’s longest-established biopharmas, with Novartis AG announcing it is to shut Morphosys AG’s facilities, following its 2024 acquisition of the one-time antibody pioneer for $2.9 billion. The closure of sites in the U.S. and Germany by the end of 2025 will affect 330 employees.
Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow tract pulmonary regurgitation.
Ophthalmic diseases specialist Oculis Holding AG announced positive phase II data showing its serum-glucose corticoid kinase-2 activator OCS-05 protected nerve cells and improved vision in patients with acute optic neuritis. The placebo-controlled, randomized trial assessed the neuroprotective effect of OCS-05 in combination with standard-of-care steroid injections, against steroids alone, with a benefit seen in preserving both ganglions and retinal cell nerve fibers.
The U.K. is embarking on the biggest overhaul of clinical trials regulations in 20 years in a bid to retake ground that was lost following Brexit, when the Medicines and Healthcare products Agency was excised from the EMA’s regulatory system.
Balt Group SAS recently secured €355 million (US$365 million) in funding to refinance its debt, invest in research and accelerate its growth. The French-based provider of interventional neuroradiology devices is looking to speed up the expansion of its global footprint, especially in the U.S.
Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.
RSS
