• 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
  • Index insights
  • 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
  • Coronavirus
  • More reports can be found here

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Trigr licenses bispecific antibody portfolio from Korea's ABL Bio in $504M-plus deal

July 5, 2018
By Michael Fitzhugh
Trigr Therapeutics Inc., a private Irvine, Calif.-based cancer drug developer founded by industry veteran George Uy, is licensing global commercial rights to five early stage antibodies from South Korea's ABL Bio Corp. for $4.3 million up front and up to $500 million in milestones, plus potential royalties. Together, the companies expect to advance development of the immunomodulatory bispecific antibodies to investigational new drug filings in the U.S. beginning next year.
Read More

Adamis taps Sandoz to sell Epipen competitor Symjepi

July 3, 2018
By Michael Fitzhugh

Adamis taps Sandoz to sell Epipen competitor Symjepi

July 3, 2018
By Michael Fitzhugh
Shares of Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) climbed 50 percent to $4.80 on Monday as – more than a year after FDA approval of Symjepi (epinephrine), its competitor for Mylan NV’s Epipen and other emergency epinephrine products – it secured a U.S. distributor and commercial partner for the product. Under terms of the 10-year deal, Adamis and Novartis Group’s generics arm, Sandoz Inc., will equally split net profits from sales of the single-dose pre-filled syringe of epinephrine.
Read More

Acceleron, Celgene see luspatercept win in MDS-linked anemia

July 2, 2018
By Michael Fitzhugh
A phase III study evaluating the ability of the red blood cell maturation agent luspatercept to help people with anemia caused by low- to intermediate-risk myelodysplastic syndromes — a type of blood cancer — minimize the need for blood transfusions met its primary endpoint, catapulting shares of drug originator Acceleron Pharma Inc. (NASDAQ:XLRN) 42.8 percent higher to $48.52 by Monday's market close. Global regulatory filings are now planned for the first half of 2019, the companies said.
Read More

Breakneck pace of IPOs continues with quintuplet of updates

June 29, 2018
By Michael Fitzhugh
One new IPO filing, three newly priced upsized IPOs and the revival of a once-postponed offering added fuel to an explosion of June fundraising, bringing the total number of IPOs on U.S. markets this month to 14, so far. Specialty pharma Aquestive Therapeutics Inc. is the latest to arrive, filing to raise up to $69 million. Meanwhile, immuno-oncology specialist Forty Seven Inc., kidney disease-focused Tricida Inc., and messenger RNA drug developer Translate Bio Inc. all increased their fundraising targets. Not to miss the moment, oral formulations expert Entera Bio Ltd. took its offering, earlier postponed, off ice.
Read More

GBT sees HOPE in phase III readout, meets disappointment over symptoms measure

June 28, 2018
By Michael Fitzhugh
South San Francisco-based Global Blood Therapeutics Inc. (GBT) is discussing pursuit of an FDA accelerated approval for its experimental sickle cell therapy, voxelotor, after meeting the primary endpoint in the first part of its pivotal phase III study, called HOPE. GBT reported statistically significant increases in hemoglobin vs. baseline using two different doses of the drug, a sickle hemoglobin shape modulator.
Read More

Achaogen's Zemdri gains cUTI approval, but draws CRL for bloodstream infection

June 27, 2018
By Michael Fitzhugh
Despite winning FDA approval on Monday to market the antibiotic Zemdri (plazomicin) to treat adults with complicated urinary tract infections (cUTI) or pyelonephritis, Achaogen Inc. saw shares (NASDAQ:AKAO) sink 20.2 percent to $9.59 on Tuesday as the agency rebuffed its effort to secure approval to use the treatment of bloodstream infections (BSIs) with a complete response letter (CRL).
Read More

Death halts second doses in Sophiris prostate cancer trial

June 26, 2018
By Michael Fitzhugh
A man with prostate cancer has died after receiving a second dose of Sophiris Bio Inc.'s topsalysin during a trial testing the inactivated pore-forming protein therapy. Investigators are now holding off on administering second doses to two additional patients as they seek further details of the death. Meanwhile, company shares (NASDAQ:SPHS) fell 40.3 percent to $2.24 on Monday, amid initial uncertainty about how soon the cause of the death would become clear.
Read More

Ironwood launches pivotal test of treatment for uncontrolled GERD

June 25, 2018
By Michael Fitzhugh
Ironwood Pharmaceuticals Inc. is kicking off twin phase III trials of a specially formulated bile acid sequestrant developed to help people with uncontrolled gastroesophageal reflux disease (GERD) minimize symptoms of the ailment, such as heartburn. The trials will test IW-3718, the lead non-guanylate cyclase-C candidate. If successful, they would provide the evidence needed to seek approval for the medicine, which would be marketed as an adjunct therapy to standard-of-care proton pump inhibitors (PPIs).
Read More

Alzheimer's strategy takes center stage in Senate committee hearing

June 21, 2018
By Michael Fitzhugh
Previous 1 2 … 84 85 86 87 88 89 90 91 92 … 179 180 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 8, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 8, 2025.
  • U.S. Capitol building, Washington D.C.

    House passes H.R. 1, restoring R&D tax cuts

    BioWorld MedTech
    The House of Representatives passed H.R. 1, also known as One Big Beautiful Bill, which will restore personal income tax cuts that expired in 2022. However, the...
  • Illustration of the β2-adrenergic receptor

    Exercise-mimicking compound offers alternative to GLP-1 therapies

    BioWorld
    An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR)...
  • Kidney disease illustration

    Prokidney produces positive phase II CKD data, thunderous stock surge

    BioWorld
    A mixed bag of top-line phase II data prompted stellar stock results for Prokidney Corp. and its chronic kidney disease (CKD) and diabetes therapy, rilparencel....
  • 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
    • Index insights
    • 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
    • Index insights
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe