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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

Although the earliest sunset of the year was actually in early December, this day also marked another premature sunset the beginning of the end of the rare pediatric disease priority review voucher program. As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended.

Disease 59
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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

Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. Over 50 rare pediatric disease priority review vouchers have been awarded to date. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

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.

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Sanofi successfully priced an inaugural sustainability-linked bond indexed on access to medicines

The Pharma Data

. €650 million fixed rate notes, due April 2029, bearing interest at an annual rate of 1.250%. million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the world’s poorest countries, between 2022 and 2026.

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Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

The Pharma Data

“While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases. About LATTICE-UC. About Ulcerative Colitis.

Trials 52
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AMGEN ISSUES INAUGURAL GREEN BOND TO ADVANCE ESG GOALS

The Pharma Data

Amgen (NASDAQ:AMGN) today announced the issuance of its inaugural $750 million green bond, with a 3.000% semi-annual coupon and maturing in 2029, to advance the environmental goals that are part of Amgen’s environmental, social and governance (ESG) framework.

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What is the largest CRO in the US?

Vial

billion by 2029. It ensures regulatory compliance for over 15 long-term post-authorization safety studies across eight disease indications. The Vial CRO Small CROs like Vial offer a high degree of specialization in specific disease areas and geographic focus. from 2024 to reach US$129.8