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BioWorld - Tuesday, April 21, 2026
Home » Authors » Brian Orelli

Articles by Brian Orelli

Artificial intelligence helps little drug developers compete

Sep. 16, 2019
By Brian Orelli
After doing deals with big pharma — Eli Lilly and Co., Merck & Co. Inc., Abbvie Inc. and Bayer AG — Atomwise Inc. announced three partnerships last week with smaller preclinical companies to use its artificial intelligence (AI) platform to develop drugs for their targets.
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FDA and EMA compare notes on drug approval decisions

Sep. 3, 2019
By Brian Orelli
There have been studies comparing approval rates of the FDA and the EMA, but an analysis of the scientific basis behind those decisions is difficult.
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Impressive start to the year for regenerative medicine companies

Aug. 19, 2019
By Brian Orelli
According to a new report from the Alliance for Regenerative Medicine, there are a whopping 932 regenerative medicine companies worldwide that are in the process of developing 440 gene therapies, 587 cell therapies and 125 tissue engineering/biomaterials products.
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Delivering gene therapy, no viruses required

Aug. 14, 2019
By Brian Orelli
While many companies use viruses and viral vectors to deliver gene therapy and to modify cells for CAR T treatments, others have shunned adeno-associated viruses (AAV) and lentiviral vectors for other methods to deliver DNA and RNA into the cells.
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Delivering gene therapy, no viruses required

Aug. 12, 2019
By Brian Orelli
While many companies use viruses and viral vectors to deliver gene therapy and to modify cells for CAR T treatments, others have shunned adeno-associated viruses (AAV) and lentiviral vectors for other methods to deliver DNA and RNA into the cells.
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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.
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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.
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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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