BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, March 20, 2026
Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Nonprofits seek new financing via priority review vouchers

July 5, 2016
By Michael Fitzhugh
With funding from the world's largest source of global health initiatives, the U.S., barely growing and global health development funding stagnant at around $36.4 billion annually, it has become increasingly clear to some that the time for creativity in funding public health programs is now.
Read More

Ampio seeking nod for osteoarthritis, despite failed Ampion 'PIVOT'al trial

July 1, 2016
By Michael Fitzhugh

Ampio Pharmaceuticals Inc. missed the primary endpoint in its second pivotal trial for Ampion, a candidate for treating osteoarthritis of the of the knee (OAK), tested under an FDA special protocol assessment (SPA).


Read More

Merck strikes cancer vaccines deal with Moderna, delivering $200M up front

June 30, 2016
By Michael Fitzhugh
Cancer vaccines tailored to fit tumor-specific profiles are at the heart of a new strategic collaboration and licensing deal between Merck & Co. Inc. and Moderna Therapeutics Inc., a company on which Merck is upping its bet as early clinical data begins to roll in as part of an earlier deal between the two targeting infectious disease.
Read More

Gilead captures approval for pan-genotypic HCV therapy

June 29, 2016
By Michael Fitzhugh
Gilead Sciences Inc. landed an on-schedule FDA approval for the chronic hepatitis C virus (HCV) drug Epclusa, the first drug effective against all six major genotypes of the virus. The fixed-dose combination tablet contains both the active ingredient of Sovaldi (sofosbuvir) and the new NS5A inhibitor velpatasvir.
Read More

Regulus retreads jaundice scare, triggering clinical hold

June 29, 2016
By Michael Fitzhugh
A serious new case of jaundice that developed during a Regulus Therapeutics Inc. study of RG-101 for the treatment of chronic hepatitis C virus (HCV) triggered the FDA to issue a verbal clinical hold on the program, sending company shares (NASDAQ:RGLS) down 49.3 percent to $2.54 on Tuesday.
Read More

Medicines advances antibiotic combo with pivotal phase III data

June 28, 2016
By Michael Fitzhugh
A potential new tool in the war on gram-negative pathogens, The Medicines Co.’s Carbavance (meropenem-vaborbactam) met both FDA and EMA primary endpoints in a pivotal phase III trial testing the therapy in patients with complicated urinary tract infections (cUTIs).
Read More

Jardiance CV death risk vote nears for FDA advisors

June 27, 2016
By Michael Fitzhugh
FDA reviewers told agency advisors in briefing docs released Friday that Jardiance (empagliflozin) postmarket data show "substantial evidence" that, for certain adults with type 2 diabetes, the drug reduces the risk of cardiovascular death. They did not recommend that the advisors support label claims that the drug could reduce the risk of either hospitalization for heart failure (HF) or a composite of CV death (excluding fatal stroke) or hospitalization for HF.
Read More

Academics heed the call for new antibiotics, but find reception mixed

June 23, 2016
By Michael Fitzhugh

IFM Therapeutics raises $27M series A for immune modulators

June 23, 2016
By Michael Fitzhugh
IFM Therapeutics Inc. closed a $27 million series A financing led by Atlas Venture and Abingworth, with participation from Novartis AG. The Cambridge, Mass.-based company, incubated at Atlas, will use the financing to advance and expand its early stage portfolio of preclinical small-molecule modulators.
Read More

Academics heed the call for new antibiotics, but find reception mixed

June 23, 2016
By Michael Fitzhugh
Academia's role in antibiotic development – crucial since the dawn of the antibiotic age when Oxford University purified penicillin ahead of mass production – remains just as important today. Despite the centrality of pioneering work undertaken at universities, challenges from basic training to funding crunches have left a yawning gap in some areas, contributing to a complex web of problems slowing the arrival of new antibiotics on the market.
Read More
View All Articles by Michael Fitzhugh

Popular Stories

  • Today's news in brief

    BioWorld

    BioWorld briefs for March 19, 2026.

  • Art concept for targeting the brain

    Precision psychiatry beyond, or before, biomarkers

    BioWorld
    There is broad agreement that psychiatric diagnoses in their current form are not reflective of any underlying biology, and that this is one of the things...
  • MRI image brain on black background

    ADPD 2026: Can we prevent dementia? Scientists quantify it

    BioWorld
    Neurodegenerative disease and cognitive decline cannot be explained by a single process. Beta-amyloid plaques, hyperphosphorylated tau, alpha-synuclein, activated...
  • Illustration of a motor neuron

    Keros reports beneficial effects of RKER-065 in ALS model

    BioWorld Science
    Keros Therapeutics Inc. has presented data regarding their activin receptor ligand trap, RKER-065, for the inhibition of the activin/myostatin signaling axis.
  • First-in-class POLG activator restores mtDNA across mutations

    BioWorld Science
    Researchers from Pretzel Therapeutics Inc. presented preclinical data of PX-578, a first-in-class POLG activator aimed at restoring mtDNA replication and...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing