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Claims Birmingham surgeon kept bones of patients probed

The Pharma Data

have all been reported to the appropriate authorities”, it would “co-operate closely with regulators” and “recommendations and learnings” had been made to staff. Circle Health Group said the “historic issues. Follow BBC West Midlands on Facebook , Twitter and Instagram.

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Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

The Pharma Data

Financial considerations AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. 4 Type I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines involved in regulating the inflammatory pathways implicated in SLE.

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Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

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Tonix Pharmaceuticals Announces Publication of Patent Application for TNX-1500 (Monoclonal Antibody Anti-CD40-Ligand) in Development for Preventing and Treating Organ Transplant Rejection and Treating Autoimmune Conditions

The Pharma Data

11):1583 (2004) 6 Karpusas M, et al. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583

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New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation

The Pharma Data

Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19.

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Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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Article EMA Thank You What Europe’s proposed Data Act means for device manufacturers: A deep dive

Agency IQ

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.