News Headlines

  1. Beta Bionics Receives IDE Approval From The FDA To Begin A Home-Use Clinical Trial Testing The New iLet™ Bionic Pancreas System

    Beta Bionics, Inc. – a medical technology company leveraging machine learning artificial intelligence to develop and commercialize the world’s first autonomous bionic pancreas – today announced that it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D).

  2. uniQure Presents New Data Demonstrating Clinical Benefit In Hemophilia B Patients With Pre-Existing Anti-AAV5 Neutralizing Antibodies

    uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, presented data showing successful liver transduction with the AAV5 vector in both non-human primates and humans with pre-existing anti-AAV5 neutralizing antibodies (NABs).

  3. Recognition For CRF Health’s World Class eSource Wins European Award

    CRF Health, a leading global provider of patient-centered eSource technology solutions for the life sciences industry, recently announced that the company has been recognized as 2018 New Entrant of the Year in Romania’s Regional IT & Outsourcing Industry Awards, (also known as the PIN Awards).

  4. First Oral Insulin For Diabetics Takes Major Step Towards FDA Approval

    Oral insulin, the Holy Grail of diabetes care that has alluded researchers for decades, is taking a major step towards becoming reality.

  5. H2020, GDPR, MDR And International Clinical Trial Regulation Blockchain Integrates CRO Solution From ClinicalStudio.EU To Manage Compliance With Smartillions Smart Contracts

    Clinical research organisations (CRO) and sponsors who sign up for ClinicalStudio.EU will be able to use a blockchain to launch Smartillions smart contracts to manage their Horizon 2020 R&D grant applications and compliance with GDPR, MDR and international clinical trial regulations.

  6. Catalent Completes $5.5M Phased Clinical Storage Expansion At Kansas City Campus

    Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, recently announced it has completed the second phase of a $5.5M expansion program at its Kansas City, Missouri facility, to increase the controlled-substance and controlled-temperature storage capabilities for its clinical supply business.

  7. Greenphire Shares Key Findings Of Site Payment Advisory Group

    Greenphire, the global leader in financial software for clinical trials, recently released key findings from meetings with nearly a dozen Clinical Research Organizations (CROs) from its Site Payment Advisory Group on the topic of investigator payment processes.

  8. Sanofi: Dupixent (dupilumab) Showed Positive Phase 3 Results In Adolescents With Inadequately Controlled Moderate-To-Severe Atopic Dermatitis

    A pivotal Phase 3 trial evaluating Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (ages 12-17) met its primary and key secondary endpoints.

  9. Albireo Enrolls First Patient In Phase 3 PFIC Trial Of A4250

    Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the first patient has been enrolled in PEDFIC-1, a Phase 3 clinical trial of lead product candidate A4250, an ileal bile acid transporter (IBAT) inhibitor being studied for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).

  10. LMC Manna Research Acquires Omnispec Clinical Research

    LMC Manna Research – the largest network of fully-owned and integrated clinical research sites in Canada providing Phase I-IV clinical trial services – recently announced the acquisition of leading Montreal-based research centre Omnispec Clinical Research.