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Medicaid and Government Pricing Congress

Drug Channels

With drug pricing and benefit coverage top of mind for many Americans, coupled with a volatile election and overall healthcare landscape, the stakes are incredibly high for bio/pharma manufacturers. Staying on the pulse of industry trends, policies and changing regulations has never been more crucial.

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Compliant Science: The Critical Role of Compliance for Medical Affairs

H1 Blog

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

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Scaling Phage Therapy

Codon

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

Therapies 117
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Q&A: The IND Journey Phase I – Navigating Success

Advarra

For more information on key components of a fit-for-purpose, phase-by-phase QMS guidance download Advarra’s whitepaper Steps to Implementing a Quality Management System. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. IRBs are subject to 21 CFR 56 IRBs.

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Moberg Pharma decides on fully guaranteed rights issue of approximately SEK 150 million

The Pharma Data

The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect,” says Anna Ljung, CEO of Moberg Pharma. The following files are available for download: View original content: [link]. SOURCE Moberg Pharma. CET on November 6, 2020.