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 6, 2026
Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Gilead-Galapagos MS drug filgotinib rejected by FDA

Aug. 19, 2020
By Michael Fitzhugh and Lee Landenberger

CBMG shareholders move to take company private

Aug. 18, 2020
By Michael Fitzhugh
A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday to $19.27, just shy of the offering price.
Read More

Unity shares untied as osteoarthritis of the knee drug fails phase II test

Aug. 17, 2020
By Michael Fitzhugh
Shares of Unity Biotechnology Inc. (NASDAQ:UBX) fell 66.6% to $4.15 on Aug. 17 after UBX-0101, its one-time lead candidate, failed to best a placebo on an established measure of osteoarthritis pain in a phase II study.
Read More
IPO line graph

Curevac IPO, bolstered by COVID-19 vaccine, debuts to surging demand

Aug. 14, 2020
By Michael Fitzhugh
Fresh off raising $640 million in private financing earlier this summer, Germany's Curevac BV burst onto the public market Friday with a $213.3 million Nasdaq IPO. Priced at a top-of-range $16 per share (NADAQ:CVAC), the company's stock rose more than 249% to close at $55.90 Aug. 14, buoyed by enthusiasm for its mRNA vaccine program against SARS-CoV-2. Majority shareholder and longtime Curevac backer Dievini Hopp Biotech Holding GmbH & Co. KG invested €100 million (US$118.3 million) in the company through a concurrent private placement.
Read More
Nanotechnology illustration

FDA works to leverage nanotech investment, better capacity for evaluation

Aug. 13, 2020
By Michael Fitzhugh
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer.
Read More

CBMG shareholders move to take company private

Aug. 12, 2020
By Michael Fitzhugh
A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday to $19.27, just shy of the offering price. "As a private company, we will have access to the resources and long-term commitment needed to better pursue new capital investment in existing assets and targeted acquisition opportunities as our sector continues to evolve, including further geographic and product diversification," CBMG CEO Tony Liu told employees.
Read More

Fennec's Pedmark lands CRL over manufacturing issues

Aug. 11, 2020
By Michael Fitzhugh
Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors.
Read More

Omeros finds narsoplimab benefits COVID-19 patients in small trial

Aug. 10, 2020
By Michael Fitzhugh
Shares of Omeros Corp. (NASDAQ:OMER) jumped 50.9% to $21.32 on Aug. 10 after it reported that six critically ill COVID-19 patients treated with its investigational lectin-pathway inhibitor, narsoplimab, recovered from the disease. The company said it will now seek government support to accelerate the drug’s large-scale manufacture. "We look forward to being able to make narsoplimab broadly available to hospitalized COVID-19 patients," said Omeros CEO Greg Demopulos.
Read More

Eagle draws CRL for new Ryanodex indication: heat stroke

Aug. 10, 2020
By Michael Fitzhugh
Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS.
Read More
Brain illustration

Biogen bets big on Denali's neurodegenerative pipeline, with $1B+ commitment

Aug. 6, 2020
By Michael Fitzhugh
Biogen Inc., one the world's top neurological disease specialists, is committing to invest more than $1 billion in cash and equity in Denali Therapeutics Inc. for rights to co-develop and co-commercialize a potential therapy for Parkinson's disease (PD) and options to secure up to four more neurodegenerative disease programs from its new partner.
Read More
View All Articles by Michael Fitzhugh

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for March 5, 2026.
  • Brain and virus with chromosome

    CROI 2026: Neurodegeneration, the challenge of aging with HIV

    BioWorld
    Antiretroviral therapies against HIV have been in use for more than 30 years and have enabled people living with HIV to maintain undetectable viral levels. Many...
  • Depression concept with human, broken brain and heavy rain

    CROI 2026 highlights depression and cognitive vulnerability in HIV

    BioWorld
    The effects of aging pose an additional challenge for people with HIV due to the neurological and psychological consequences that persist despite antiretroviral...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for March 3, 2026
  • Concept art for headache

    Slate Medicines launches with focus on headache disorders

    BioWorld Science
    Slate Medicines Inc. has launched with $130 million in series A financing and a focus on advancing next-generation therapeutics for migraine and other headache...
  • 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