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Clinical trials authorised for 3D-printed ulcerative colitis drug

European Pharmaceutical Review

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Novel haemophilia B gene therapy approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

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EMA validates first regulatory submission for CRISPR-based medicine

European Pharmaceutical Review

The edited cells, exa-cel, are then infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT). The elevation of HbF by exa-cel has the potential to reduce or eliminate painful and debilitating vaso-occlusive crises for patients with SCD and alleviate transfusion requirements for patients with TDT.

Medicine 111
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Citrate-free HCF of adalimumab biosimilar gets positive opinion

European Pharmaceutical Review

Upon approval, the adalimumab citrate-free high concentration (100mg/ml) formulation will have the same auto-injector, the currently offered drug delivery option. According to the EMA, TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hyrimoz is used to treat.

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ESG Top Trends: Technology trends

Pharmaceutical Technology

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Additionally, AI can improve patient wellbeing by automating health records, predicting illness, and enhancing treatment efficiency. 3D bioprinting offers an alternative to animal testing in drug development.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2015; 13:8-17. 2015; 12(10):931-934. Tuijin Jishu / Propuls. cited 2023Dec].

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MicroPort Navibot Receives 510(K) Clearance for its SkyWalker™ Robot-Assisted Platform for Orthopedic Applications

Legacy MEDSearch

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. was established in China in 2015 and is a subsidiary of MicroPort Scientific Corporation.