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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....

The therapy is intended for patients who have undergone at least three previous therapies, including an immunomodulatory agent and a proteasome inhibitor. The approval is the first authorisation The post IASO Bio gains Hong Kong approval for Fucaso application appeared first on Pharmaceutical Business review....

The approval enables the use of inavolisib in patients whose cancer has recurred during or shortly after hormone therapy and has metastasised to other areas of the body. The post MHRA approves Roche Products' inavolisib for breast cancer appeared first on Pharmaceutical Business review....

The decision is intended for those who have previously been treated with a Bruton's tyrosine kinase (BTK) inhibitor. This application is based on data from a global, open-label, The post BeOne's sonrotoclax gains priority FDA review for mantle cell lymphoma appeared first on Pharmaceutical Business review....

The approach is consistent with outpatient settings as per US Food and Drug Administration (FDA)-approved use. The initiative enhances access to non-oral diuretic therapy throughout CVL's cardiovascular practice The post Corstasis Therapeutics partners CVL for Enbumyst integration appeared first on Pharmaceutical Business review....

The deal sets the vaccine price at $2.99 per dose and is expected to take effect within a year, supporting Gavi's goal to fully vaccinate 50 million more The post UNICEF and Gavi to widen affordable malaria vaccine access appeared first on Pharmaceutical Business review....

Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a The post FDA grants accelerated approval for Otsuka's IgAN therapy appeared first on Pharmaceutical Business review....

Cellergy will utilise the good manufacturing practices (GMP) expertise of Made Scientific to enhance its mitochondrial isolation and purification process for the clinical-grade production of CLG-001. This work The post Made Scientific and Cellergy partner to advance CLG-001 appeared first on Pharmaceutical Business review....

This therapy is intended for children aged two years and above, teens and adults with SMA who have a confirmed mutation in the survival motor neuron 1 (SMN1) The post Novartis secures approval from FDA for Itvisma to treat SMA appeared first on Pharmaceutical Business review....

The investment covers both expansion of the Frederick biologics manufacturing facility and a new plant construction in Gaithersburg, targeting operational readiness by 2029. The Frederick site, which produces The post AstraZeneca to expand biomanufacturing in Maryland, US appeared first on Pharmaceutical Business review....

The agreement includes an exclusivity period of six months for negotiating and finalising a definitive agreement, pending due diligence and board approvals. Vaximm is eligible for an upfront The post Vaximm and BCME link on oral cancer immunotherapy platform appeared first on Pharmaceutical Business review....