• 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

FDA approved icons and medical professional

Orencia becomes first FDA-approved drug to prevent aGVHD

Dec. 16, 2021
By Michael Fitzhugh
Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants.
Read More

Pfizer's Paxlovid holds ground in final analysis, while Adagio's ADG-20 stumbles

Dec. 14, 2021
By Michael Fitzhugh
Little more than a year since FDA approval of its COVID-19 vaccine, Pfizer Inc. has published final phase II/III data on its oral antiviral candidate, Paxlovid (nirmatrelvir + ritonavir), confirming that, for non-hospitalized, high-risk adults with COVID-19, taking the drug within three days of symptom onset reduced all-cause risk of hospitalization or death by 89% vs. placebo.
Read More

Medicago poised to seek approval for plant-based COVID-19 vaccine

Dec. 7, 2021
By Michael Fitzhugh
Mitsubishi Tanabe Pharma Corp.'s Medicago Inc. plans to "imminently" seek Health Canada approval for its plant-based COVID-19 vaccine candidate, MT-2766, after top-line phase III results showed an overall vaccine efficacy rate of 71% against all variants of SARS-CoV-2.
Read More

Recordati poised to acquire Eusa Pharma for about $817.5M

Dec. 6, 2021
By Michael Fitzhugh
Milan-based Recordati SpA has proposed acquiring the global specialty pharma Eusa Pharma Ltd., a specialist in rare and niche oncology, for about €724 million (US$817.5 million) net of around €26 million in debt Eusa held at last report, midyear. The transaction offers Recordati a "great growth opportunity" while giving it the chance to "build scale in a new-for-us and very attractive and underserved therapeutic area," thus providing further diversification for Recordati's existing rare diseases business, said Chairman Andrea Recordati.
Read More
Digital stock chart

Sobi shares fall as $8B bid for company is withdrawn

Dec. 3, 2021
By Michael Fitzhugh
Swedish Orphan Biovitrum AB shares (STO:SOBI) fell 25% Dec. 3 as investors behind Agnafit Bidco AB, previously poised to pay about SEK72.17 billion (US$7.97 billion) for the company, withdrew their bid as shares tendered fell just short of the 90% needed to complete the deal. The bid was seen as likely to succeed after Investor AB, which owns 35% of the capital and votes in the company, commonly called Sobi, supported it. However, with only 87.3% of outstanding shares tendered as of Dec. 3, Agnafit decided to drop the offer, foregoing further extension of the acceptance period, which was earlier extended by ten days to Nov. 26 in hopes of collecting enough support.
Read More
Gold wireframe handshake

Novartis taps UCB in $1.65B Parkinson's disease deal

Dec. 2, 2021
By Michael Fitzhugh
Novartis AG, keen to expand its central nervous system franchise as generics chase down crown jewel Gilenya (fingolimod), has secured rights from UCB SA to co-develop and commercialize two potential Parkinson's disease therapies for $150 million up front and milestone payments approaching $1.5 billion.
Read More
Cytomegalovirus in a human cell

A new first as FDA approves Takeda drug to treat CMV in transplant recipients

Nov. 30, 2021
By Michael Fitzhugh
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
Read More

Krystal nears BLA filing for potential EB therapy, buoyed by pivotal trial success

Nov. 29, 2021
By Michael Fitzhugh
Shares of Krystal Biotech Inc. (NASDAQ:KRYS) rocketed 121.7% higher, to $88.44 on Nov. 29, after top-line data showed its investigational gene therapy for dystrophic epidermolysis bullosa (DEB) achieved the primary endpoint of a pivotal phase III trial, healing 67% of skin wounds associated with the disease vs. placebo at six months.
Read More

A new first as FDA approves Takeda drug to treat CMV in transplant recipients

Nov. 24, 2021
By Michael Fitzhugh
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
Read More
Skin irritation on hands

Connect sees positive readout in phase IIb AD trial, but Dupixent comps a mystery for now

Nov. 19, 2021
By Michael Fitzhugh
A phase IIb trial of Connect Biopharma Holdings Ltd.'s CBP-201 in adults with moderate-to-severe atopic dermatitis (AD) showed all three doses tested reduced eczema severity vs. placebo by a statistically significant percentage at 16 weeks, meeting the trial's primary efficacy endpoint.
Read More
Previous 1 2 3 4 5 6 7 8 9 10 11 12 … 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