• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Authors » Brian Orelli

Articles by Brian Orelli

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.
Read More

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.
Read More

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.
Read More

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.
Read More

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.
Read More

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.
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.
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).
Read More

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). 


Read More
Previous 1 2 … 8 9 10 11 12 13 14 15 16 … 55 56 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 23, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for May 23, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for May 20, 2025
  • Drug capsule and dollar sign

    Little bite from voluntary most-favored nation Rx pricing order

    BioWorld
    After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite,...
  • Illustration of liver with DNA double helixes

    ASGCT 2025: Gene and cell therapies transform metabolic diseases

    BioWorld Science
    Metabolic disorders such as argininosuccinic and glutaric aciduria, methylmalonic acidemia, homocystinuria or primary hyperoxaluria require specific diets to...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe