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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.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Lorrie Vuolo-Schuessler has been involved with ISPE and the GAMP © Community of Practice leadership since 2002 and is currently Chair of the GAMP Americas Steering Committee and a member of the GAMP Global Leadership Team. FDA, Computer Software Assurance for Production and Quality System Software – Draft Guidance. FDA, 2022. .

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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. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. sustaining life)?

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A history of blood cancer treatment

pharmaphorum

Thanks to the dedicated efforts of doctors, patients, carers, and healthcare professionals, people diagnosed with blood cancer are now living longer, with a steady stream of more effective treatments entering the market each year. 2002 – Emergence of CAR-T therapy. 2002 – Emergence of CAR-T therapy.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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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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