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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

Interestingly, based on a review of the 709 Orphan Products Clinical Trials Grants awarded since 1983 that are listed in FDA’s public database , as of October 1, 2024, only 48 Phase 3 trials have been granted an award (eight of which were Phase 2/3 trials). Relative to other areas of medicine (e.g.,

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Tryngolza (Olezarsen) Becomes First FDA-Approved Drug for Familial Chylomicronemia Syndrome

XTalks

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. Tryngolza works by targeting a protein in the liver, apoC-III, which regulates triglyceride metabolism. FCS also severely impacts quality of life, causing chronic fatigue and recurrent stomach pain.

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Email Marketing Campaigns for Pharma: Boost Engagement & Compliance

Pharma Marketing Network

The key lies in personalization, strategic segmentation, and strict adherence to industry regulations. Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. oncology, diabetes, cardiology). Therapeutic area focus (e.g.,

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Former FDAer Dr. Ellis F. Unger Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory Expert

FDA Law Blog

Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). While at FDA, Dr. Unger’s Office oversaw the approval and regulation of scores of new drugs for cardiovascular, renal, neurological, and psychiatric disorders.

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Agent Drug-Coated Balloon: A New Era in Coronary In-Stent Restenosis Treatment

XTalks

Treatment options like it not only have the potential to improve patient care but also to influence future research directions and treatment strategies in interventional cardiology.

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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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