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A Visual Guide to Gene Delivery

Codon

Some diseases are caused by mutations in large genes that exceed the packaging limits of existing vectors like adeno-associated virus (AAV). Its exact packaging size can vary by serotype, and there are now more than 20 antigenically distinct types of AAV. Still, AAV’s most obvious limitation remains its packaging capacity (~4.7

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Vamorolone

New Drug Approvals

7 (2021) 13. [70] 7 (2021) 13 Chemistry Vamorolone is a synthetic corticosteroid and is also known by the chemical name 17α,21-dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione or as 16α-methyl-9,11-dehydroprednisolone. “Drug Approval Package: Agamree” U.S. Goemans, S. Mercuri, A. Guglieri, P.R. Clemens, S.J.

FDA
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Levers for Biological Progress

Codon

More specifically, it reveals that the price to sequence a human genome fell from $100 million in 2001 to $700 by 2021; a stunning collapse in price. Perhaps you’ve seen this chart before, which shows the falling costs of DNA sequencing over the last two decades. The cost of sequencing a human genome.

DNA
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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

When educating elderly patients: Be patient and take extra time to explain concepts Use larger print materials for easier reading Address concerns about changes in pill appearance or packaging Communicating with Young Adults Younger patients may be more open to generic drugs but might lack knowledge about how they work. ” FDA.gov, 2021.

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Limited Evidence for Nalfmefene

Common Sense for Drug Policy Blog

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively).

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AZVUDINE

New Drug Approvals

SYN [link] Azvudine was approved for the treatment of adult HIV-1 infection in China in 2021, and it was approved for conditional marketing for the treatment of SARS-CoV-2 in China in 2022. It was approved in China in 2021 as a first-in-class treatment for human immunodeficiency virus (HIV). 2021, 6, 414. (9) Signal Transduct.

RNA
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Have You Missed Any FDA Data Submission Requirements? A Look at Substantial Changes and New Requirements

Cytel

1 The following December, a second version was released after public comments and, on December 16, 2014, the FDA stopped the clock, providing sponsors with a pivotal two-year window to adapt their methods of creating clinical dataset packages to comply with the FDA’s new required data standards for any study commencing after December 16, 2016.

FDA