Agency IQ

SEPTEMBER 29, 2023

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.

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The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. That would leave 19% of staff affected by furloughs.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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BMG Labtech

FEBRUARY 24, 2025

Protein nitration is one example that takes place on tyrosine residues which can have important consequences for the regulation of biological processes. 2004 Mar 23;101(12):4003-8. Epub 2004 Mar 12. 3 in this blog adapted from this reference under license CC-BY 4.0. Proteomics. 2015 Jan;15(2-3):185-7. doi: 10.1002/pmic.201400592.

Small Molecule 52

Small Molecule Disease Licensing Licensing 52

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Cell (2002).

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DNA Cell Biology Molecular Biology Engineering 98

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & & Xie X.S.

DNA 52

DNA Cell Biology Engineering Molecular Biology 52

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. Brown , 348 F.3d

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