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Articles

PDA meeting showcases widening range of resources

More Tools for Handling Temperature-Controlled Shipping

New group of injectables manufacturers tussles with USP over use of labeling ‘real estate’ on vial caps

Out With Pedigree; In With Patient Safety

Two prefilled-syringe projects emphasize user friendliness

Syringe Design Gets a Makeover

Optimized dimensionality is the goal of new products from MTS and Cold Chain Technologies

Refinements in Cold Chain Secondary Packaging

Contract packagers are multiplying their product offerings to meet marketing and patient-safety concerns

The Packaging Contribution to Patient Adherence

Colorcon Opens West Coast Technology Center

Functional (“peel-off”) labels, common in Europe for injectables, represent a significant packaging improvement for safer and more efficient drug administration

Functional labels enhance patient safety and boost market access

The goal is to provide greater access to HIV prevention drugs in low-income countries.

Gilead Signs Licensing Deals with Generic Manufacturers for Lenacapavir Production

Why it's critical for companies to set long-term, strategic goals in their journeys toward decarbonization. 

Tapping the Value of Conscientious Stewardship

New facilities are expected to focus on manufacturing next-generation medicines and biologic medicines. 

Eli Lilly, Johnson & Johnson Invest in New Drug Manufacturing Facilities

It’s essential for commercial success, but presents its share of obstacles.

Beyond the Finish Line: Why Post-Approval Regulatory Strategy Matters

The project is funded by Scottish Enterprise, and aims to boost commercial manufacturing of injectable drug product.

Symbiosis Purchases New Production Plant in Scotland 

Editor Nicholas Saraceno, Bill Roth, SVP, Managing Partner, Blue Fin Group, speaks on key takeaways from his "Fight for the Dollar" keynote speech. 

Access Insights 2023: Bill Roth Provides an Overview of his Keynote Speech, Fight for the Dollar

: The keynote was a culmination of a story that I've been working on all year long. We've always heard about the flow of the dollar. I'm getting quite tired of that one graphic that represents how brands flow. There's nine other flows. What became obvious to us over the last year and a half was this concept of the fight for the dollar. No one is really laying back and allowing the channels to basically use the manufacturers. Between 340B, the removal of the AmCap, and the addition of the IRA, price increases as we know it have been abolished. If you do it moving forward, you're going to wind up regretting the actions. The way that I open it up, I ask this question: If you put a dollar bill equidistant in a four way intersection and you put a payer pharmacy/distributor equal to that and a gun goes off, who gets to the dollar bill first and why? Traditionally, the answer has been not the manufacturer. The fight for who gets that money has created awkwardness and I think the ability to talk about that in front of a group like this is great because we're putting a problem on the table that we all need to solve. 

SVP and Managing Director for Blue Fin Group offers a synopsis of the conference opener. 

Latest Conference Coverage

 editor Nicholas Saraceno, Andrew Brownlee, director, Berkeley Research Group, discusses how manufacturers calculate 340B pricing. 

Access Insights 2023: Andrew Brownlee Discusses How Manufacturers Calculate 340B Prices

: It is subject to a formula that all manufacturers have to provide. For branded pharmaceuticals, it is a ceiling price, which means that it's the maximum price that a manufacturer can charge for a 340B priced product. That ceiling price is subject to a discount of the unit rebate amount (URA). The URA is the greater of 23.1%, or the best price, which is essentially the greatest discount that the manufacturer offers on the branded product. Each 340B discount is also subject to an inflationary penalty, so if the list price of the product grows faster than core inflation, then there would be an additional discount added to the URA. 

Berkeley Research Group executive speaks about the role of manufacturers in 340B pricing. 

Manufacturing & Packaging

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