News Headlines

  1. Sharp’s Netherlands Facility Approved for Clinical Operations

    Sharp - part of UDG Healthcare plc, a global leader in contract packaging and clinical supply services, has received Wholesale Distribution Authorisation (WDA) and Investigational Medicinal Product (IMP) licensing approvals to support clinical activities from its facility in Heerenveen, Netherlands. 

  2. Momotaro-Gene Announces First Patient Dosed In Phase 2 Clinical Trial Of MTG201 In Combination With Nivolumab In Patients With Relapsed Malignant Pleural Mesothelioma

    Momotaro-Gene, a clinical-stage biotherapeutics company developing novel gene therapies for the treatment of cancer, today announced the dosing of the first patient in a Phase 2 clinical trial combining MTG201, the company’s lead therapeutic candidate, with the PD-1 inhibitor nivolumab (Opdivo®) in patients with relapsed malignant pleural mesothelioma.

  3. More Emerging Biopharma And CROs Adopting Veeva Vault CDMS

    An increasing number of emerging biopharma companies and leading contract research organizations (CROs) are adopting Vault CDMS from Veeva Systems (NYSE:VEEV) to manage their clinical data. More life sciences organizations are using Veeva Vault CDMS for multiple clinical trials to drive greater speed and agility in study execution.

  4. CytoDyn Announces FDA Clearance To Proceed With Phase 2 Study Of Leronlimab (PRO 140) And Regorafenib As A Combination Therapy For Metastatic Colorectal Cancer

    CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the FDA has allowed a Phase 2 study to proceed for combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC).

  5. Advarra Announces Intent to Acquire Forte, Market-Leading Provider of Clinical Technology Solutions

    The move strengthens the site-centric solutions portfolio of the largest global research compliance services organization

  6. Inventiva Achieves A Major Milestone By Completing Patient Recruitment For Its Phase IIb Clinical Study With Lanifibranor In NASH

    Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, recently announced the successful completion of patient recruitment for its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor, the Company’s lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH).

  7. Idera Pharmaceuticals Announces Immuno-Oncology Clinical Research Collaboration With Abbvie

    Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) announced today that they have entered into an immuno-oncology clinical research collaboration with AbbVie, a global, research-based biopharmaceutical company.

  8. Aduro Biotech Announces First Patient Dosed In Phase 2 Study Of ADU-S100 (MIW815) In Combination With KEYTRUDA® (pembrolizumab) For First-Line Treatment Of Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma (HNSCC)

    Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, today announced that the first patient has been dosed in a Phase 2 clinical trial of ADU-S100 (MIW815), a novel STING pathway activator, in combination with KEYTRUDA®(pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

  9. uniQure Announces Achievement Of Planned Enrollment In HOPE-B Pivotal Trial Of AMT-061 (Etranacogene Dezaparvovec) In Patients With Hemophilia B

    uniQure N.V., a leading gene therapy company advancing transformative therapies for patients with severe unmet medical needs, recently announced that the planned enrollment of 56 patients has been achieved in the HOPE-B pivotal trial of etranacogene dezaparvovec (AMT-061), an investigational AAV5-based gene therapy incorporating the patent-protected FIX-Padua variant for the treatment of patients with severe and moderately severe hemophilia B.

  10. Taconic Biosciences Participates In Second Rodent Research Reference Mission To The International Space Station

    Taconic Biosciences, a global leader in providing genetically engineered animal model solutions, announces its participation in the second Rodent Research Reference mission to the International Space Station.