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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinical development.

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Lilly’s Lepodisiran Achieves Over 90% Reduction in Heart Disease Marker in Phase II Trial

XTalks

The Phase II results were presented at the American College of Cardiology 2025 Scientific Sessions. Lilly shared that the ACCLAIM-Lp(a) Phase III clinical development program is currently enrolling. The findings suggest that lepodisiran could offer a durable treatment option for individuals with elevated Lp(a) levels.

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Vericiguat approved in Japan to treat patients with chronic heart failure

The Pharma Data

The companies share equally the costs of the development of vericiguat. About Cardiology at Bayer Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments.

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BlueRock secures FDA fast track; Omniscient rakes in $29M; Neuspera’s nerve implant gets a $65M boost Rivus’ therapy nabs $35M

Delveinsight

Joachim Fruebis, chief development officer of BlueRock, said that receiving fast track designation from the FDA is a crucial step, which will help them further progress clinical development of their DA01 cell therapy approach for Parkinson’s disease.

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Bayer delivers on medical innovation fueling transformation of pharma business

The Pharma Data

We are taking bold steps into the future of drug development, investing strongly in areas at the forefront of the biomedical and technological revolution. Every year 47 million women enter menopause, a period where women are at the peak of their life’s activity, personally and professionally.

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Novo Nordisk moves chronic kidney disease drug ziltivekimab into phase 3

pharmaphorum

Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinical development in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal. Data were announced at the virtual American College of Cardiology annual conference and published simultaneously in The Lancet.

Drugs 52
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BlueRock Therapeutics Announces Completion of Enrollment of Phase 1 Trial in Patients with Parkinson’s Disease

The Pharma Data

Senior Vice President, Clinical Development, BlueRock Therapeutics. “We We are excited that our Phase 1 clinical trial has completed enrollment and believe it is a critical next step toward the development of a novel cell therapy that has the potential to transform the treatment landscape for this devastating disease.”.

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