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The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved

FDA Law Blog: Drug Discovery

Earlier in the week, it was reported that there was a bipartisan agreement on a bill that would have funded the government and extended the first sunset date for the rare pediatric disease priority review voucher program for nearly 5 years, until September 30, 2029.

Disease 59
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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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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

This bill would extend the designation deadline until September 30, 2029, a five-year extension (and would require yet another GAO report). It was shortly thereafter introduced in the Senate and referred to the Committee on Health Education, Labor, and Pensions, where it remains.

Disease 64
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Calico and Broad Institute extend collaboration, adding focus on age-related neurodegeneration

Broad Institute

Initially announced in March 2015, this renewed agreement extends the collaboration until September 2029 and will continue to support ongoing programs focused on the biology and genetics of aging as well as early-stage drug discovery. Terms of the agreement were not disclosed. “We

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Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing

Alta Sciences

billion by 2029. Inside the Altascientist: Considerations for Safe and Compliant HPAPI Manufacturing pmjackson Fri, 03/08/2024 - 19:35 In recent years, advancements in oncological research have fueled a surge in demand for highly potent active pharmaceutical ingredients ( HPAPIs ).

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

Agency IQ

The preceding version of the EUDAMED roadmap, released late in 2023, showed milestones through 2029 for each of the six modules – actor, devices, certificates, market surveillance, vigilance and CI/PS. 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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CytomX Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock – Jan 21, 2021

The Pharma Data

The CytomX clinical-stage pipeline includes potentially first-in-class product candidates against previously undruggable targets, including a CD166-targeting Probody drug conjugate wholly owned by CytomX (CX-2009) and a CD71-targeting Probody drug conjugate partnered with AbbVie (CX-2029).