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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances. Ken Phelps.

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Should we be worried about pharma’s supply chain?

World of DTC Marketing

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Why would a pharma company take risks like these?

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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact.

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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

Nothing epitomises market failures more than the cost of insulin,” Newsom said in a video posted on Twitter. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

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Five Trends in Contract Drug Manufacturing Organisations

Pharmaceutical Technology

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

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Common sense approach to the pharma industry

World of DTC Marketing

SUMMARY: The “goodwill” that many believe was gained from the development of a Covid-19 may be more of a wish than a reality. Pharma companies are still too focused on profits while people continue to rely on prescription drugs to compensate for unhealthy lifestyles. Are prescription drugs priced too high?

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Katie Porter attacks pharma

World of DTC Marketing

So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). I have worked with and stayed in contact with some R&D people within pharma and they have a different answer. In pharma R&D returns have declined to 1.8 percent—a slight decrease of 0.1

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