RegulationApprovalsDrug Manufacturing September 22, 2025 J&J’s Tremfya gets FDA approval for SC induction in active UC By PBR Staff Writer Tremfya is a fully-human, dual-acting monoclonal antibody that works by selectively targeting IL-23, a protein involved in abnormal immune activity. The drug is already approved in the US
Drug Manufacturing September 19, 2025 Biogen to acquire Alcyone Therapeutics for $85m By PBR Staff Writer ThecaFlex DRx is an investigational implantable device to deliver antisense oligonucleotides (ASOs) intrathecally. The device administers medicines to patients with neurologic disorders. It is designed to offer an
RegulationApprovalsDrug Manufacturing September 18, 2025 Deciphera’s Romvimza secures EC nod for TGCT treatment By PBR Staff Writer This authorisation is specifically for patients who have symptomatic TGCT, with significant physical functional decline, and for whom surgical intervention is either not an option or would lead
Drug Manufacturing September 17, 2025 Dualitas secures $65m for bispecific antibody pipeline By PBR Staff Writer The investment round was jointly spearheaded by Qiming Venture Partners USA and Versant Ventures. It also saw contributions from SV Health Investors, the company’s founding investor, and new
Research & Development September 16, 2025 Argo Biopharma secures NMPA clearance for Phase II PNH trial By PBR Staff Writer Phase II study of BW-40202, a small interfering RNA (siRNA) therapy targeting complement factor B (CFB), is planned to commence in January 2026. The therapy is also being
Drug Manufacturing September 15, 2025 YolTech Therapeutics raises approximately $45m via Series B financing By PBR Staff Writer The funds will help YolTech in advancing its clinical programmes and global strategic execution. Established in 2021, YolTech Therapeutics is stated to be advancing next-generation in vivo gene-editing
Research & Development September 12, 2025 Dewpoint Therapeutics secures funding for DPTX3186 development By PBR Staff Writer The company aims to achieve early clinical proof-of-concept for the therapy by late 2026. Dewpoint noted that the financing will also expedite the development of its first-in-class c-mod
Neurology September 10, 2025 FDA grants breakthrough therapy status to Ionis ION582 to treat Angelman syndrome By PBR Staff Writer AS, a rare neurological disorder often diagnosed in infancy, affects approximately one in 21,000 individuals worldwide and is caused by the loss of function of the maternal UBE3A
Research & Development September 9, 2025 Novonesis and Novo Nordisk collaborate on gut microbiome research initiative By PBR Staff Writer The gut microbiome is composed of microorganisms, including viruses, bacteria, and fungi, that naturally reside in the human gut. The companies will work together to investigate solutions aimed
ApprovalsDrug Manufacturing September 8, 2025 Takeda receives FDA approval for Vonvendi sBLA By srivani venna VWD is the most prevalent inherited bleeding disorder in the US, affecting over three million individuals, with both men and women equally susceptible. Vonvendi is also approved for