News Headlines

  1. SDC Establishes Strategic Scientific Consulting Group To Expand Protocol And Program Development Services

    SDC is excited to announce a new key initiative: the establishment of a Strategic Scientific Consulting group. This initiative will support continued efforts to broaden the range of strategic-level support that SDC provides to clients and partners throughout the lifespan of their clinical development programs.

  2. Bioclinica Delivers Individual Case Safety Report (ICSR) Processing With Quality And Consistency While Crossing One Million Case Milestone In 2017

    Bioclinica®, the world-leading provider of scientific- and technology-enabled solutions for clinical research, recently announces its ICSR team delivered quality and consistency in Individual Case Safety Report (ICSR) processing while crossing the one million case milestone in 2017 –setting a new Company record, while enabling several ‘Top 20’ drug safety operations clients to meet their global regulatory requirements for safety reporting.

  3. ACRP, Singapore Clinical Research Institute (SCRI) Partner To Raise CRC Professionalism In Singapore

    The Association of Clinical Research Professionals (ACRP) and Singapore Clinical Research Institute (SCRI) recently announce a new partnership to raise clinical research coordinator (CRC) professionalism in Singapore.

  4. Shire, Microsoft And EURORDIS Form Global Commission To Accelerate Time To Diagnosis For Children With Rare Diseases

    Shire plc (LSE: SHP, NASDAQ: SHPG), Microsoft and EURORDIS-Rare Diseases Europe today announced a strategic alliance to address the diagnostic challenge for patients living with a rare disease. The long road to diagnosis is one of the most important issues affecting the health, longevity and well-being for rare disease patients and their families.

  5. Wave Life Sciences And Takeda Form Global Strategic Collaboration To Advance Therapies For Central Nervous System Disorders

    Wave Life Sciences Ltd. a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, recently announced the formation of a global strategic collaboration with Takeda Pharmaceutical Company Limited to discover, develop and commercialize nucleic acid therapies for disorders of the central nervous system (CNS).

  6. Applied Therapeutics Initiates Phase 1 Trial For AT-001 In Diabetic Complications

    Applied Therapeutics Inc., a privately-held biotechnology company focused on developing transformative drugs in areas of high unmet medical need, recently announced initiation of a Phase 1 clinical trial for AT-001, an oral small molecule in development for diabetic complications.

  7. Celgene’s Acquisition Of Juno Therapeutics Puts The Company In A Good Position To Be A Frontrunner In The CAR-T Space, Says GlobalData

    Celgene’s recent announcement of the acquisition of Juno Therapeutics has put the company in a good position to be a frontrunner in the chimeric antigen receptor- T cell (CAR-T) space. 

  8. Abeona Therapeutics Receives FDA Orphan Drug Designation For ABO-202 Gene Therapy Program In Infantile Batten Disease

    Abeona Therapeutics Inc, a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced recently that the FDA has granted Orphan Drug Designation (ODD) to its ABO-202 program (AAV-CLN1), an AAV-based gene therapy for the treatment of infantile Batten disease.

  9. Bracket Appoints New CEO Michael Nolte

    Bracket, a leading clinical trial technology and specialty services provider, recently announced the appointment of Michael P. Nolte as Chief Executive Officer.

  10. U.S. FDA Files New Drug Application Under Priority Review For Migalastat For Treatment Of Fabry Disease

    Amicus Therapeutics (Nasdaq:FOLD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for filing under priority review for the oral precision medicine migalastat HCl ("migalastat") for the treatment of patients 16 years and older with Fabry disease who have amenable mutations.