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Posts by David Ridley

Preview
20 Years Of Priority Review Vouchers, A Tool For Spurring Needed Drugs If the FDA approves a drug for a neglected tropical disease, the company gets a voucher that accelerates review of another drug. This remains controversial.

How did an Australia-based nonprofit bring a drug to market for a disease concentrated in sub-Saharan Africa? In this piece, Christine Ro uses the story of moxidectin to explain how FDA priority review vouchers can spur neglected-disease drug development.
www.forbes.com/sites/christ...

2 days ago 0 0 0 0
Beni: Surviving Sleeping Sickness
Beni: Surviving Sleeping Sickness YouTube video by Drugs for Neglected Diseases initiative (DNDi)

With Sanofi, @dndi.org developed fexinidazole, a cure for sleeping sickness, a deadly parasitic disease spread by the tsetse fly. They earned a priority review voucher. Here is a 5-minute story about one patient: youtu.be/GcIx32MDdkU?...

4 months ago 1 0 0 0

In 2003, Médecins Sans Frontières (Doctors Without Borders) launched the Drugs for Neglected Diseases initiative (@dndi.org) to create affordable treatments for neglected illnesses. It's a remarkable story of do-gooders becoming drug makers.

4 months ago 3 0 1 0

If you're in the Triangle area and curious about the human microbiome, the science behind taste, or how benign parasites might impact medicine, join us at @fuqua.duke.edu on March 20 at 12:45 in the Kirby Reading Room for a talk by Rob Dunn, biologist and author of "Delicious" and other books.

1 year ago 4 1 1 0

If a drugmaker increases its commercial price over time, it must pay a rebate to the US government. This somewhat dampens price increases and lowers the net price paid by the government. But what if the drugmaker resets its price by launching a new version? @warren.senate.gov wants an investigation.

1 year ago 1 0 0 0
Dr. Shelley Hwang - Surgical Oncologist, Mountain Climber
Dr. Shelley Hwang - Surgical Oncologist, Mountain Climber YouTube video by Duke University School of Medicine

Less is often more, according to Shelley Hwang, MD, MBA, of @DukeU. In @JAMA_current, she and coauthors demonstrated that monitoring is a safe, less invasive approach for low-risk ductal carcinoma in situ (DCIS).
Video: youtu.be/_fuC8cFlsXU
Article: jamanetwork.com/journals/jam...

1 year ago 3 0 0 0
Preview
Novel Drug Approvals for 2024 Novel Drug Approvals for 2024

The @US_FDA published a great summary of novel drug approvals in 2024 here:
www.fda.gov/drugs/novel-...

1 year ago 0 0 0 0
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In 2024, @US_FDA approved 50 novel drugs, including:
• 34 first approved in the US
• 26 orphan drugs (<200K Americans affected)
• 7 accelerated approvals (conditional approval on surrogate endpoints)
• 28 priority reviews (6-month FDA review)

Cancer drug Bizengri was all 4.

1 year ago 0 0 1 0