Navigating the new regulatory terrain pharma companies face with IRA and 340B

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The ever-evolving landscape of pharmaceutical regulations has long been challenging to navigate, but now pharma companies face additional complexities with the introduction of the Inflation Reduction Act (IRA) and the ongoing implementation of the 340B drug pricing program. In recent years, the IRA has made waves for its impact on the pharmaceutical industry, including proposals to allow Medicare to negotiate drug prices for the first time and imposing rebates on drug price increases that outpace inflation. Additionally, the 340B Drug Pricing Program, which was created in 1992, is a U.S. federal government program that aims to allow healthcare organizations to offer affordable prescription drugs to underserved and low-income populations. In 2021, 340B backed entities purchased $43.9 billion worth of covered outpatient drugs under the program.

To get a clearer sense of how the indu…

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Biden names 31 tech hubs: Here are 10 relevant to pharma and biotech

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Traditionally, the tech and biotech sectors in the U.S. have been concentrated in a handful of regions — most notably in areas such as Boston, Seattle, Silicon Valley and Southern California. But the Biden administration aims to distribute innovation more evenly through the U.S. To that end, the administration has designated 31 tech hubs across the U.S. to help drive innovation and job creation in a variety of industries.

These tech hubs are part of a competitive program involving $500 million in federal funding, with each hub eligible to apply for $50–$75 million to drive innovation in their respective focus areas. Here, we highlight 10 hubs that are especially relevant to the pharma and biotech sectors, describing their unique focus areas.

Three of the regions were featured in an earlier Drug Discovery & Development roundup on emerging biotech hubs: Baltimore, Maryland; Mad…

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Purdue University launches institute for advanced manufacturing of pharmaceuticals

Thanks to a donation from pharma industry veteran William D. Young, Purdue University has announced plans to launch a new institute dedicated to furthering pharmaceutical manufacturing to reduce costs and bolster access to new biotech drugs.

The William D. Young Institute for Advanced Manufacturing of Pharmaceuticals is named after the eponymous chemical engineer, who graduated from Purdue in 1966. Yong went on to become the chief operating officer of Genentech from 1980 to 1999. Young is now a senior advisor to Blackstone Life Sciences (South San Francisco and Cambridge, Massachusetts).

“We’re honored to receive this gift from a man with a global reputation as a talented chemical engineer who built an outstanding technical and management record in pharmaceutical and biotech manufacturing,” said Purdue President Mitch Daniels in a statement. “Everyone in pharma knows that having Bill Young’s name on the sign means we will be working to the highest standards and…

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