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BioWorld - Sunday, January 25, 2026
Home » Authors » Brian Orelli

Articles by Brian Orelli

FDA to advisory committees: we hear your opinion, but . . .

Aug. 2, 2019
By Brian Orelli
"It's a rare window into seeing how the FDA makes decisions because the proceedings are open unlike many of the other decisions they make," Audrey Zhang, a medical student at the New York University School of Medicine, said on why she decided to embark on crunching the numbers from 376 votes by FDA advisory committee meetings from 2008 to 2015.
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FDA to advisory committees: we hear your opinion, but . . .

July 29, 2019
By Brian Orelli
“It’s a rare window into seeing how the FDA makes decisions because the proceedings are open unlike many of the other decisions they make,” Audrey Zhang, a medical student at the New York University School of Medicine, said on why she decided to embark on crunching the numbers from 376 votes by FDA advisory committee meetings from 2008 to 2015.
Read More

Rare disease drugs on the rise as multiple factors drive development

July 15, 2019
By Brian Orelli
Drugs for rare diseases now account for 31% of R&D pipelines, up from 18% in 2010 and just 11% in 2005, according to a report from the Tufts Center for the Study of Drug Development. That's currently nearly 3,500 drugs in development, more than double the 1,530 in 2010.
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Rare disease drugs on the rise as multiple factors drive development

July 15, 2019
By Brian Orelli
Drugs for rare diseases now account for 31% of R&D pipelines, up from 18% in 2010 and just 11% in 2005, according to a report from the Tufts Center for the Study of Drug Development. That's currently nearly 3,500 drugs in development, more than double the 1,530 in 2010.
Read More

Gene therapy goes CNS with Zolgensma FDA OK

July 5, 2019
By Brian Orelli
In late May, Novartis AG's Avexis Inc. unit gained FDA approval for Zolgensma (onasemnogene neparvovec) to treat spinal muscular atrophy, and other companies are looking to follow suit developing drugs to treat a variety of diseases of the central nervous system (CNS).
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Gene therapy goes CNS with Zolgensma FDA OK, more to come

June 28, 2019
By Brian Orelli

In late May, Novartis AG's Avexis Inc. unit gained FDA approval for Zolgensma (onasemnogene neparvovec) to treat spinal muscular atrophy, and other companies are looking to follow suit developing drugs to treat a variety of diseases of the central nervous system (CNS). 


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TFF inhales another $8.2M to support thin film freezing tech

June 3, 2019
By Brian Orelli

TFF inhales another $8.2M to support thin film freezing tech

May 31, 2019
By Brian Orelli
Adding on to its $14 million series A round in April 2018, TFF Pharmaceuticals Inc. has secured another $8.17 million for the round to support development of its namesake thin film freezing (TFF) technology that was developed to increase the solubility of drugs.
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Clinical trial productivity on the decline, hope for a turnaround

May 28, 2019
By Brian Orelli
Despite the strong growth in the number of drugs approved by the FDA over the last few years, clinical trial productivity fell 27% from 2013 to 2018, according to a report from the Iqvia Institute for Human Data Science.
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Clinical trial productivity on decline, hope for a turnaround

May 28, 2019
By Brian Orelli
Despite the strong growth in the number of drugs approved by the FDA over the last few years, clinical trial productivity fell 27% from 2013 to 2018, according to a report from the Iqvia Institute for Human Data Science.
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