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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.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” FDA, 2022. . About the authors.

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Cancer: Progress but a long way to go

World of DTC Marketing

The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. But it’s’ still the leading cause of cancer deaths. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found. sustaining life)?

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline.

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Cardiovascular Medical Device Sales With Marc Toth

Evolve Your Success

He discusses why the future of the healthcare industry in the United States lies not in hospital buildings but in surgery centers. One in insurance, retail and healthcare that is still around. The foods are put on the trays, then go up to the person who has a diabetic diet. It’s the first drug-eluting heart stent in the world.

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