• 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 » Newsletters » BioWorld

BioWorld

April 26, 2017

View Archived Issues

Regulatory front

Active pharmaceutical ingredients (APIs) produced at Divi Laboratories Ltd., of Chippada Village, India, were put on import alert nearly four months after officials at the facility refused to provide FDA investigators with the original, unmodified audit trail data from Divi's chromatographic systems used to test APIs for the U.S. market. Read More

Other news to note

Uniqure NV, of Amsterdam, said AMT-060, its gene therapy for patients with severe hemophilia B, has received PRIME designation by the EMA, based on results from the ongoing, dose-ranging phase I/II study that show a near cessation of spontaneous bleeding in patients with severe disease at up to 12 months follow-up, along with clinically significant and sustained increases in factor IX (FIX) and substantial reductions in FIX replacement usage. Read More

In the clinic

Asterias Biotherapeutics Inc., of Fremont, Calif., said the data monitoring committee recommended continuation of enrollment in the SciStar phase I/IIa trial testing AST-OPC1 for acute spinal cord injury (SCI), with the 10 million and 20 million cell dose cohorts to continue as planned, following an interim review. Read More

Financings

Circle Pharma Inc., of South San Francisco, completed an expansion of its series A financing, with new investors WI Harper Group, Elements Partners LLC, Whitesun Healthcare Ventures Ltd. and Lifeforce Capital joining the round. Read More

EASL updates its hepatitis B guidelines to include Vemlidy

AMSTERDAM – Hepatitis B treatment guidelines, newly updated by the European Association for the Study of the Liver to help doctors navigate what EASL governing board member Frank Tacke told BioWorld Today is "lots of dynamic change" during the last couple years, have become the first to recommend the use of the most recently approved HBV drug, Vemlidy. Read More

Annexin Pharma lines up annexin A5 for vascular disorders

DUBLIN – Annexin Pharmaceuticals AB completed a listing on the First North exchange in Stockholm last week and is on track to begin clinical trials of its first-in-class therapy for inflammatory vascular disease by year-end. Read More

Is it forum shopping or a matter of convenience?

Should a state court be able to determine the legal precedent for the entire nation when it comes to injury claims against drug or device companies? Read More

STRIVE heralds arrival of new migraine options

BOSTON – "STRIVE establishes calcitonin gene receptor peptide (CGRP) receptor blockade as the first ever mechanism-specific, migraine targeted preventive treatment approach," Peter Goadsby told his audience at the 2017 annual meeting of the American Academy of Neurology. Read More

Epimab nabs $25M to develop its bispecifics pipeline in China

SHANGHAI – Epimab Biotherapeutics Inc., of Shanghai, now has $25 million in its coffers to put its lead candidate into clinical development, a bispecific antibody for oncology. Read More

Capricor trial yields positive data in DMD-linked heart disease

Patients with Duchenne muscular dystrophy (DMD) and advanced heart disease enrolled in an exploratory study of Capricor Therapeutics Inc.'s candidate, CAP-1002, saw, at the study's six-month midpoint, improved measures of cardiac structure and upper limb function. The interim data suggest that the therapy, composed of allogeneic cardiosphere-derived cells, could help stave off decompensated heart failure, a common cause of death for individuals with DMD. Read More

Spinraza 'sprinting out of the gates' to drive Biogen's first-quarter revenues

Cowen and Co. analyst Eric Schmidt summed up the sentiment of analysts on Biogen Inc.'s first-quarter financials, headlining a note on the company's "solid" performance with the observation that the spinal muscular atrophy (SMA) drug Spinraza (nusinersen) was "sprinting out of the gates." Read More

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 9, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 9, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 3, 2025
  • Biotech deal illustration

    City hits the town with $1B-plus deal with Biogen

    BioWorld
    A development deal with Biogen Inc. could eventually bring City Therapeutics Inc. about $1 billion in milestone payments. It’s a step in the direction the company...
  • Cancer cell in the cross-hairs

    Pan-cancer proteome atlas reveals new biomarkers and targets

    BioWorld Science
    An international group of scientists has completed the first draft of The Pan-Cancer Proteome Atlas (TPCPA). The project is based on mass spectrometry of 22...
  • 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