PBR Nachrichten

 

The approval marks the first new treatment for the adult population with PPF in more than five years, offering a new alternative for those with this life-threatening lung The post Boehringer's Jascayd gains China's NMPA approval for PPF appeared first on Pharmaceutical Business review....

This next-generation central nervous system (CNS)-penetrant will be developed by Bleecker Bio, a newly established subsidiary of Formation. Lynk Pharmaceuticals will obtain a minority equity stake in Bleecker, The post Formation Bio gains global rights to Lynk Pharma's TYK2 inhibitor appeared first on Pharmaceutical Business review....

The approvals mark the fourth and fifth clearances for the company in the country in 2025. Qfitlia is the antithrombin-lowering therapy indicated for routine prophylaxis in individuals with The post China's NMPA approves Sanofi's rare haematologic disease treatments appeared first on Pharmaceutical Business review....

The multi-programme partnership leverages Zealand Pharma's experience in obesity and metabolic health alongside OTR Therapeutics' research and development (R&D) platform to address the needs of people with metabolic The post Zealand Pharma and OTR to develop metabolic disease therapeutics appeared first on Pharmaceutical Business review....

Formycon will complete the development of FYB206, prepare and file the regulatory dossier, and supply the biosimilar product. Zydus will manage its commercialisation. FYB206 is nearing the end The post Formycon and Zydus sign exclusive agreement for FYB206 supply appeared first on Pharmaceutical Business review....

The once-daily oral therapy is administered as a 14-day course. Clinical trials demonstrated benefits from as early as day three, with significant symptom reduction by day 15, and The post Health Canada approves Biogen's Zurzuvae for PPD treatment appeared first on Pharmaceutical Business review....

Lupus nephritis classifications indicate the severity and type of kidney damage, which is central to the disease. The EC's decision is based on outcomes from the Phase II The post EC approves Roche's Gazyva to treat active lupus nephritis appeared first on Pharmaceutical Business review....

The Digital Acceleration of Toxicity Assessment with Mechanistic and AI-driven Predictions (DATAMAP) project, in collaboration with Baylor College of Medicine, Amgen, Torch Bio and Cincinnati Children's Hospital Medical The post Inductive Bio gains $21m ARPA-H funds for drug prediction models appeared first on Pharmaceutical Business review....

The initiative aims to enhance biotechnology research and innovation in the region. The new memorandum of understanding (MOU) was signed to mark the 15-year collaboration between the two The post Agilent and Monash University Malaysia to set up biodiscovery hub appeared first on Pharmaceutical Business review....

Viatris will sell all of its convertible preferred equity in Biocon Biologics. The deal value comprises $415m in newly issued Biocon equity shares and $400m in cash. The The post Viatris signs agreements with Biocon on $815m stake sale appeared first on Pharmaceutical Business review....

Denali's lead investigational TransportVehicle-enabled enzyme replacement therapy is intended to treat mucopolysaccharidosis type II (Hunter syndrome, a rare genetic disorder affecting boys). The US Food and Drug Administration The post Denali makes $275m funding agreement with Royalty Pharma appeared first on Pharmaceutical Business review....

In October 2025, the two companies signed the deal as part of their focus on bispecifics and ADCs. The agreement aims to expedite the worldwide development and commercialisation The post Takeda and Innovent fulfil close conditions for ADC and IO therapies appeared first on Pharmaceutical Business review....

The licensing agreement covers Thailand, Singapore, the Philippines and Indonesia, granting Rxilient rights to market APP13007, a patented medicine for treating inflammation and pain after ocular surgery. It The post Formosa and Rxilient sign licensing agreement for APP13007 appeared first on Pharmaceutical Business review....

This applies to patients previously treated with a covalent Bruton tyrosine kinase (BTK) inhibitor. The approval broadens Jaypirca's label to cover patients at an earlier stage of treatment The post FDA approves Eli Lilly's Jaypirca in relapsed or refractory CLL/SLL appeared first on Pharmaceutical Business review....

With this collaboration, drug developers get access to the technology, which is designed to increase yields and reduce the time required to reach clinical trials. The ATUM's transposase-based The post AGC Biologics to expand cell line development with ATUM partnership appeared first on Pharmaceutical Business review....

The partnership brings together Citizen Health's AI-based patient insights and advocacy networks with the expertise of UCB in drug development to improve patient outcomes. Under this agreement, Citizen The post Citizen Health and UCB collaborate for epilepsy drug development appeared first on Pharmaceutical Business review....

The designation, which covers serious and life-threatening diseases affecting those under 18, may allow the company a paediatric priority review voucher for future regulatory submissions. SGT-212 is designed The post Solid Biosciences' SGT-212 gains FDA rare paediatric disease status appeared first on Pharmaceutical Business review....

This submission is the initial application for VIZZ under the exclusive licence and commercialisation agreement signed between LENZ Therapeutics and Lotus in May 2025, and includes South Korea The post Lotus submits NDA for VIZZ in South Korea to treat presbyopia appeared first on Pharmaceutical Business review....

The formulation will serve as a new administration route. Eisai's application is based on data from several SC administration sub-studies of lecanemab, conducted within the Phase III Clarity The post Eisai seeks PMDA approval for subcutaneous Leqembi in Japan appeared first on Pharmaceutical Business review....

The company will manufacture the product at its biotechnology facility in Pune, India, which has undergone a previous FDA inspection. Armlupeg is indicated to reduce the risk of The post US FDA approves Lupin's Armlupeg injection appeared first on Pharmaceutical Business review....