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The collaboration follows a successful pilot phase, where XtalPi's integrated quantum physics and AI algorithms achieved improved hit rates, highlighting the platform's capability to address the complex metabolic target. The post XtalPi enters $400m partnership for small molecule therapy for GPCR target appeared first on Pharmaceutical Business review....

EMA has now begun reviewing its use in adults following a non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA). The validation confirms the application is complete The post EMA validates Bayer's asundexian application for ischaemic stroke appeared first on Pharmaceutical Business review....

Upon completion of the transaction, Ignite will separate from Aditxt and is expected to become an independent public company via the establishment of a new holding entity, anticipated The post Aditxt and Ignite announce merger plans with strategic partner appeared first on Pharmaceutical Business review....

The programme will investigate the ways in which AI can enhance the evaluation of precision and safety, better forecast risks, and identify impacts that current methods might overlook. The post MHRA to roll out new AI sandbox for medicines development appeared first on Pharmaceutical Business review....

The deal centres on enhancing targeted treatments for solid tumours driven by KRAS mutations, which are considered especially challenging to treat. The companies stated that the Firelink DAC The post J&J to acquire Firefly Bio for $1bn to enhance oncology pipeline appeared first on Pharmaceutical Business review....

The approval covers patients aged 12 years and older with inhibitors, as well as children aged six to 11 years, with or without inhibitors. Hympavzi is approved for The post Pfizer's Hympavzi secures FDA expanded indications for haemophilia appeared first on Pharmaceutical Business review....

The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Aqneursa is approved across the EU The post EC grants marketing authorisation for IntraBio's Aqneursa appeared first on Pharmaceutical Business review....

The partnership includes a five-year licence for Owkin's K Pro, an AI platform designed to augment drug discovery and development. Since 2021, Sanofi and Owkin have maintained a The post Sanofi and Owkin partner to develop next-generation biopharma AI agents appeared first on Pharmaceutical Business review....

This partnership provides the biopharmaceutical company with early access to the Chai-3 model alongside a dedicated model tailored to Pfizer's proprietary data and workflows, underscoring a strategic move The post Pfizer signs licence agreement with Chai for AI drug discovery appeared first on Pharmaceutical Business review....

This advance recognises preliminary data indicating that salanersen may show substantial improvement over existing therapies for SMA. The FDA's decision follows data from a Phase Ib study on The post Biogen's salanersen gains FDA breakthrough therapy designation for SMA appeared first on Pharmaceutical Business review....

The collaboration aims to conduct a full technical and operational assessment of Cellares' automated manufacturing and testing platforms. This is in preparation for the anticipated demand surrounding TSC-101 The post Cellares and TScan to assess automated manufacturing of TSC-101 therapy appeared first on Pharmaceutical Business review....

The collaboration combines CytomX's Probody technology with Regeneron's Veloci‑Bi bispecific platform to target hard‑to‑treat tumour types. Established in 2022, the partnership combines CytomX's biologic masking technology with Regeneron's The post Regeneron and CytomX extend cancer therapy partnership to $4bn deal appeared first on Pharmaceutical Business review....

This marks the second indication for Aquipta in the EU, where it is now approved both for acute attacks and as a once-daily preventive treatment for adults experiencing The post AbbVie receives EC approval for Aquipta to treat migraine appeared first on Pharmaceutical Business review....

The application seeks approval of giredestrant as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I to III breast The post Roche's giredestrant secures FDA priority review for breast cancer appeared first on Pharmaceutical Business review....

The regulator granted the application priority review for this indication, assigning a Prescription Drug User Fee Act (PDUFA) date of 30 September 2026. Camzyos is currently approved for The post BMS secures FDA acceptance for Camzyos sNDA appeared first on Pharmaceutical Business review....

The value includes a $1.55bn upfront payment and as much as $1.1bn in regulatory and commercial milestone payments. The acquisition aligns with Servier's strategic goal in rare neurology, The post Servier to acquire Edgewise's muscular dystrophy business for $2.65bn appeared first on Pharmaceutical Business review....

The agreement covers Hanmi's candidate that uses its LAPSCOVERY long-acting platform technology. Sonefpeglutide combines Hanmi's proprietary technology and has previously achieved approval from the US Food and Drug The post Lilly and Hanmi sign $1.26bn licensing deal for sonefpeglutide appeared first on Pharmaceutical Business review....

This marks the first approved immunotherapy combination for this patient segment in the US. The approval relies on positive data from the POTOMAC Phase III trial, which was The post FDA approves AstraZeneca's Imfinzi-BCG combination for NMIBC therapy appeared first on Pharmaceutical Business review....

The agreement covers antibody-drug conjugates with new payloads and multi-specific antibodies featuring distinct immune-engaging mechanisms. The portfolio consists of eight drug candidates originating from Innovent Biologics and four The post Pfizer and Innovent Biologics sign $10.5bn cancer drug development deal appeared first on Pharmaceutical Business review....

If approved, venglustat would be the first treatment in the US to address the neurological symptoms of GD3, which currently have no targeted therapies. The decision is anticipated The post FDA grants priority review for Sanofi's venglustat NDA appeared first on Pharmaceutical Business review....