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Clinical research courses

  • Basilea announces submission of Investigational New Drug application for novel oncology drug candidate BAL0891

    Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with cancer and infectious diseases, announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), to start clinical studies with the company’s novel drug candidate BAL0891 in cancer therapy. BAL0891 is a potential first-in-class small-molecule kinase inhibitor.

  • Iovance Biotherapeutics announces Clinical Data for Lifileucel in Combination with Pembrolizumab in Advanced Cancers

    Iovance Biotherapeutics, Inc a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced clinical data for lifileucel in combination with pembrolizumab in patients with advanced cancers were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. A slide presentation is also available on the Iovance website.

  • Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5-11 Years

    Pfizer Inc and BioNTech SE announced that the U.S. Food and Drug Administration has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.

  • Silver Bullet Therapeutics Launches OrthoFuzIon Bone Screw System

    Silver Bullet Therapeutics, Inc a privately-held medical device company, announced today that it is formally launching its antimicrobial OrthoFuzIon Bone Screw System at the DKOU German Congress of Orthopedics and Traumatology on October 26-29 in Berlin.

    Silver Bullet Therapeutics OrthoFuzIon product line will be featured at the Argomedical booth at Nr. 61 in Hall 4.2.

  • Roche launches comprehensive genomic profiling kit

    Roche announced that it has launched the AVENIO Tumor Tissue CGP Kit. The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house. Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer.

  • CANOPY-1 Phase III study did not demonstrate the statistically significant primary endpoints

    Novartis announced that the CANOPY-1 Phase III study did not demonstrate the statistically significant primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients treated with canakinumab (ACZ885) combined with pembrolizumab plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus platinum-based doublet chemotherapy.

  • Advanced Radiation Therapy, LLC and Apollo Healthcare Announce Strategic Partnership

    Advanced Radiation Therapy, LLC (ART) and Apollo Healthcare have today announced a strategic partnership aimed at easing the challenge radiation oncology clinics have in pre-authorizing patients for insurance coverage for innovative radiation cancer therapies.

  • FDA approves Susvimo for macular degeneration

    Roche announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo  (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or wet age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month.

  • Aino Health is approved by Swedish Social Insurance Agency as a workplace-oriented rehabilitation support organizer

    Swedish Social Insurance Agency (Försäkringskassan), has granted Aino Health approval to provide proactive and rehabilitative efforts in the workplace. In collaboration with Swedish Social Insurance Agency, Aino Health can offer support investigating, planning, implementing and following up on work-oriented measures.  

    The purpose of the grant is to prevent sick leave and make it easier for employees to return to work after sick leave. 

  • Dupixent (dupilumab) is the first biologic to significantly reduce itch and skin lesions in Phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease

    PARIS and TARRYTOWN, N.Y. – October 22, 2021 - A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions, met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch.

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