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  • Polaroid Therapeutics Announces Strategic Hire: Ma

    Polaroid Therapeutics Announces Strategic Hire: Markus Rothmaier Takes Helm of Research and Development

    • 19 Apr 2024
    • Editor

    Polaroid Therapeutics, a Swiss-based biotech start-up, today announces the appointment of Markus Rothmaier as its inaugural Head of Research and Development (R&D).

  • Regulatory Affairs Employers in Europe

    Regulatory Affairs Employers in Europe

    • 17 Apr 2024
    • Editor

    An up-to-date list of employers in Europe, hiring for regulatory affairs positions right now.

  • Servier Executive Committee appointments

    Servier Executive Committee appointments

    • 17 Apr 2024
    • Editor

    Previously Head of the Group Transformation & Programs Office, Charlotte Marmousez-Tartar is promoted to the position of Executive Vice President, Corporate Strategy and Transformation. She joined the Executive Committee on February 1, 2024, succeeding Siham Imani.

  • Sciensus appoints Hugues Hervouet as its Chi

    Sciensus appoints Hugues Hervouet as its Chief Technology Officer

    • 17 Apr 2024
    • Editor

    Hugues Hervouet has been appointed as Sciensus’ Chief Technology Officer. Hugues joins Sciensus having recently served as Senior Vice President and Chief Information Officer at Shutterstock, a leading global technology provider offering high-quality digital content, tools and services.

  • Martin Meeson, former CEO of Fujifilm Diosynth Bio

    Martin Meeson, former CEO of Fujifilm Diosynth Biotechnologies succeeds Sylke Hassel following the integration of Novasep

    • 17 Apr 2024
    • Editor

    Axplora, a leading partner to Pharma companies and Biotechs for complex APIs, is pleased to announce the appointment of Martin Meeson as its new Chief Executive Officer (CEO).

  • New 48-week frexalimab phase 2 data support potent

    New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis

    • 17 Apr 2024
    • Editor

    Sanofi’s CD40L antibody, frexalimab, demonstrated sustained reduction of disease activity and favorable tolerability after nearly one year in participants with relapsing multiple sclerosis.

  • Takeda Recognized with 2024 ISPE Facility of the Y

    Takeda Recognized with 2024 ISPE Facility of the Year Awards in Category Operations

    • 17 Apr 2024
    • Editor

    Takeda (TSE:4502/NYSE:TAK) today announced that the International Society for Pharmaceutical Engineering (ISPE) has awarded the company top honors in the category Operations with the 2024 Facility of the Year Awards (FOYA).

  • Lantern Pharma is harnessing the power of AI and M

    Lantern Pharma is harnessing the power of AI and Machine Learning to Fight Cancer

    • 16 Apr 2024
    • Editor

    This year, the United States expects to tally more than two million new cancer diagnoses— a first-ever prediction— and more than 611,000 cancer-related deaths.

  • What Does a Clinical SAS Programmer Do?

    What Does a Clinical SAS Programmer Do?

    • 16 Apr 2024
    • Lucy Walters

    Within the realm of clinical research, a Statistical Analysis System (SAS) Programmer is responsible for managing, analysing, and interpreting clinical data utilising SAS software. This includes developing and applying statistical techniques to assess the efficacy, safety, and value of a pharmaceutical product or medical procedure.

  • Roche’s Columvi meets primary endpoint of overall

    Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study

    • 16 Apr 2024
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival.

  • Viatris Appoints Corinne Le Goff as Chief Commerci

    Viatris Appoints Corinne Le Goff as Chief Commercial Officer

    • 16 Apr 2024
    • Editor

    Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced that Corinne Le Goff has joined the company as Chief Commercial Officer and will become a member of the company's Executive Leadership Team, effective today.

  • Fresenius Accelerates Momentum in its (Bio)Pharma

    Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®*, its Third Approved Biosimilar in the U.S.

    • 16 Apr 2024
    • Editor

    Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne® (tocilizumab-aazg), a biosimilar of Actemra®** (tocilizumab). Tyenne®, for use in the treatment of chronic autoimmune diseases, is available in an intravenous (IV) formulation.

  • TLX101-CDx (Pixclara™) Granted FDA Fast Track Desi

    TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation

    • 16 Apr 2024
    • Editor

    Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).

  • Labcorp Announces First-of-Its-Kind Test for Early

    Labcorp Announces First-of-Its-Kind Test for Early Indication of Neurodegenerative Diseases and Brain Injuries Using a Blood Draw

    • 16 Apr 2024
    • Editor

    Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the availability of the nation's first test for glial fibrillary acidic protein (GFAP), a critical blood-based biomarker for the early detection of neurodegenerative diseases and neurological injuries.

  • Vertex Enters Into Agreement to Acquire Alpine Imm

    Vertex Enters Into Agreement to Acquire Alpine Immune Sciences

    • 11 Apr 2024
    • Editor

    Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a biotechnology company focused on discovering and developing innovative, protein-based immunotherapies, today announced that the companies have entered into a definitive agreement under which Vertex will acquire Alpine for $65 per share or approximately $4.9 billion in cash.

  • Roche granted FDA Breakthrough Device Designation

    Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

    • 11 Apr 2024
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

  • Labcorp Receives FDA Emergency Use Authorization f

    Labcorp Receives FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit

    • 11 Apr 2024
    • Editor

    Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox.

  • The Evolution of Clinical Data Management

    The Evolution of Clinical Data Management

    • 10 Apr 2024
    • Lucy Walters

    Clinical Data Management (CDM) has drastically transformed over the years, proactively adapting to technological advancements, changing regulations, and the growing complexity of clinical trials.

  • Eli Lilly's and AstraZeneca's former head of resea

    Eli Lilly's and AstraZeneca's former head of research Dr. Jan Lundberg invests in AlzeCure and is proposed for election to its board

    • 10 Apr 2024
    • Editor

    AlzeCure Pharma AB (”AlzeCure” or ”the Company”), a pharmaceutical company that develops candidate drugs for CNS diseases, focusing on Alzheimer's disease and pain, today announced that Professor Jan Lundberg invests in the company and is proposed as a new member of the company's board of directors.

  • Cambridge Cognition strengthens senior management

    Cambridge Cognition strengthens senior management team to deliver growth

    • 10 Apr 2024
    • Editor

    Cambridge Cognition, a leader in digital health solutions for brain health assessment, has announced the appointments of Alex Livingstone-Learmonth as Chief Commercial Officer and Annabelle Miles as Head of Marketing.