• 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 » drug development

Articles Tagged with ''drug development''

Final guidances pouring out of US FDA

Dec. 21, 2023
By Mari Serebrov
With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the development of monoclonal antibodies to treat or prevent COVID-19 to the use of real-world data in drug development.
Read More

EMA, FDA offer help with challenges of expedited drug programs

Dec. 20, 2023
By Mari Serebrov
Given the challenges of generating chemistry, manufacturing and control information on the compressed timelines used in the EMA’s Priority Medicines scheme and the U.S. FDA’s breakthrough therapy designation program, the two regulators published a joint question-and-answer document discussing quality and good manufacturing practice aspects of applications for both programs, which are aimed at speeding development of innovative products to address unmet medical needs.
Read More
Celltrion building and skyline

Celltrion, Celltrion Healthcare merger kicks off, rolling three-into-one ‘big pharma’

Aug. 22, 2023
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. is rolling out a tweaked plan to merge its three affiliates – electing for a two-way merger followed by consolidation with the final branch – in its latest efforts to rise through the ranks and emerge as a “true” big pharma.
Read More
Celltrion building and skyline

Celltrion, Celltrion Healthcare merger kicks off, rolling three-into-one ‘big pharma’

Aug. 18, 2023
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. is rolling out a tweaked plan to merge its three affiliates – electing for a two-way merger followed by consolidation with the final branch – in its latest efforts to rise through the ranks and emerge as a “true” big pharma.
Read More
3D Euro symbol

Vesalius closes €95M fund IV, with 60% going to drug development

June 29, 2023
By Nuala Moran
Vesalius Biocapital Partners Sàrl has called a first close on its fourth fund at €95 million (US$103 million) and now is targeting a total of €150 million, with new investors to be accepted on a "rolling closing" basis until the final close in 2024.
Read More

Driven by need, adcom gives thumbs up to FOP drug

June 28, 2023
By Mari Serebrov
Despite imperfect data and the use of post hoc analyses to overcome a failed endpoint, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 June 28 that Ipsen SA’s ultra-rare bone disease drug, palovarotene, demonstrated efficacy in treating patients with fibrodysplasia ossificans progressiva (FOP).
Read More

US FDA provides draft guidance on mpox drugs

Jan. 19, 2023
By Mari Serebrov
Just as the U.S. mpox public health emergency declaration is about to end, the FDA is releasing a draft guidance on developing drugs and biologics to treat infections caused by the virus.
Read More
EU flag and light bulb

EFPIA: Time for Europe to regain its Rx innovation

Nov. 8, 2022
By Mari Serebrov
Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers.
Read More
RNA targeting technology
Drug Design, Drug Delivery & Technologies

RNA sensor technology enables cell-specific targeting

Oct. 11, 2022
By W. Todd Penberthy
Two research teams independently reported in the Oct. 5, 2022, issues of Nature (Duke University) and Nature Biotechnology (Stanford University) on the development of RNA sensing technologies designed to target cell-specific RNA sequences to form a double-stranded RNA:RNA hybrid that is then edited by endogenous ADAR proteins to remove a stop codon and ultimately enabled to express any protein placed within the construct. The target design typically starts from single-cell RNA transcriptomics data that previously identified cell-specific RNA transcriptomics.
Read More
Hands holding test tubes at laptop

Combinatorial analytics identifies hundreds of precise drug repositioning opportunities

June 17, 2022
By Patrick Cole
It is well known that the development of a new drug is exorbitantly expensive and is a process which usually fails. Researchers at PrecisionLife posit that failure and the many patients with unmet treatment needs result from an over simplistic view of disease pathogeneses and an overreliance on a narrow range of target genes and pathways.
Read More
Previous 1 2 3 4 5 6 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for May 9, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for May 9, 2025.
  • US flag, stock market chart, White House

    100 days of uncertainty

    BioWorld
    The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the...
  • AI generated, 3D rendering of protein degradation

    AACR 2025: Induced proximity strategy, beyond degraders

    BioWorld
    Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical...
  • NME Digest: Q1 2025

    BioWorld
    A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications...
  • 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