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Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. Therefore, it is essential that we broaden the scope of medical trials and research,” commented Tinamarie Duff, DAWN Global People & Business Resource Group Lead.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

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Reflecting on five years of quality control for nitrosamine impurities

European Pharmaceutical Review

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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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). 2018; 22(5):1589-1604. 2018; 15(141):20170387. Tuijin Jishu / Propuls.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use.

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How the US’s pending PIE Act will improve patient access to medication

pharmaphorum

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. The AMCP backed bill (H.R. The history of PIE.

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Shorter timelines, evolving strategies: Four key trends in regulatory approvals of new medicines

Clarivate

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs. N) = number of approvals.