• 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 » Michael Fitzhugh

Articles by Michael Fitzhugh

Remdesivir capsule

Fauci calls remdesivir 'new standard of care' for COVID-19 as FDA works with Gilead to aid drug’s availability

April 29, 2020
By Michael Fitzhugh
Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
Read More

Gilead touts 'positive' data from COVID-19 trial, new phase III data

April 29, 2020
By Michael Fitzhugh

Regeneron, Sanofi tweak IL-6 study to focus on critical COVID-19 cases

April 27, 2020
By Michael Fitzhugh
Preliminary data from the first part of a phase II/III trial testing the interleukin-6 (IL-6) receptor antibody Kevzara (sarilumab, Regeneron Pharmaceuticals Inc. and Sanofi SA) in patients with severe or critical respiratory illness caused by COVID-19 found that, relative to a placebo, the medicine "had no notable benefit on clinical outcomes" among that combined group.
Read More
Steadying hand while reaching for glass

Neurocrine expands commercial portfolio, winning U.S. approval for Parkinson's drug

April 27, 2020
By Michael Fitzhugh
A once-daily add-on therapy for Parkinson's disease (PD) used in Europe for years has now gained clearance in the U.S. with FDA approval of Ongentys (opicapone). The drug, an improvement upon generics in its class, will be sold by Neurocrine Biosciences Inc. The medicine, a catechol-O-methyltransferase (COMT) inhibitor first approved by the EMA in 2016, extends the half-life of levodopa, increasing doses of which are required to achieve motor control as PD progresses. Portugal-based Bial-Portela & Ca SA, from which Neurocrine licensed North American rights to the drug, will receive a $20 million award from its partner. Shares of San Diego-based Neurocrine (NASDAQ:NBIX), a neuroscience company focused on treating movement disorders, rose 3.5% following the approval, closing at $101.67 on April 27.
Read More

Neurocrine's Parkinson's drug wins FDA approval

April 27, 2020
By Michael Fitzhugh
Drug vials and syringe

Affinivax raises $120M series B to advance MAPS vaccines and immunotherapies

April 23, 2020
By Michael Fitzhugh
With completion of a $120 million series B financing, Affinivax Inc. said it's poised to advance several new vaccine candidates for hospital-associated infections into the clinic even as its partner, Astellas Pharma Inc., carries its lead pneumococcal vaccine candidate, ASP-3772, through an upcoming phase III program.
Read More
Silhouette made of crumpled paper illustrating depression

Supernus inks Navitor pact, betting up to $475M on depression candidate

April 22, 2020
By Michael Fitzhugh
Supernus Pharmaceuticals Inc. has struck an agreement with privately held Navitor Pharmaceuticals Inc. to run a joint phase II program for Navitor's mTORC1 activator, NV-5138, in treatment-resistant depression (TRD).
Read More

Incyte wins FDA approval for first targeted cholangiocarcinoma treatment

April 21, 2020
By Michael Fitzhugh
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
Read More

Scynexis sees path for antifungal asset approval with new pivotal data

April 21, 2020
By Michael Fitzhugh
New pivotal data on Scynexis Inc.'s lead candidate, an antifungal for vulvovaginal candidiasis (VVC), have cleared the path to an NDA filing in the indication later this year and a potential approval in mid-2021.
Read More

Incyte wins FDA approval for first targeted cholangiocarcinoma treatment

April 20, 2020
By Michael Fitzhugh
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
Read More
Previous 1 2 … 41 42 43 44 45 46 47 48 49 … 179 180 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