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Maximize Established Brands Value

Fierce BioTech

In the coming period, pharma should witness an ongoing transformation, as exclusivity rights to 569 medications valued at $278 billion (2022 sales) are set to expire by 2029/2030. These are brands that are often neglected as they near maturity, with revenue and profit growth suboptimized. Click here to login.

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Fewer New Drugs but Affordable Access for Existing Ones: The Big Elephant in the Room

Policy Prescription

Would you vote for legislation to lower drug prices that would lead to a five percent reduction in pharmaceutical innovation — yet simultaneously create a health system in which all Americans could afford the prescription drugs they need? That’s compared to the one we have now where a quarter of Americans struggle with drug prices.

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Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing

Alta Sciences

So much so that the HPAPI market is estimated to reach USD 31.5 billion by 2029. In each issue, they share their decades of knowledge to help sponsors along their early-phase drug development journeys, as well as explore the latest challenges and innovations in the industry. Tags Manufacturing and Analytical Services Weight 1

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

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Article EMA Thank You Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

Agency IQ

This database was created to share post-market surveillance information across E.U. Ultimately, this module will interact with CTIS , the drug clinical trial information system. But if usage weren’t mandatory until halfway through 2029, which is five years from now, it won’t be useful for tracking this for some time.

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Quality vs Quantity: Strategies For Device Manufacturers to Succeed in the Current Marketplace

H1 Blog

In fact, the global medical devices market is projected to grow from $495.46 billion by 2029. Understanding and incorporating the payer perspective and data requirements early in product development is essential in this increasingly cost-conscious market. billion in 2022 to $718.92 50,666,744 are enrolled in Medicare Part D.

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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