Current Headlines

  1. PBT2 Recommended For Orphan Designation In Europe

    Prana Biotechnology is pleased to announce the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending designation of PBT2 for the treatment of Huntington disease as an orphan medicinal product to the European Commission (EC)

  2. PharmaEngine Announces Merrimack Completed MM-398 (PEP02) New Drug Application Submission To U.S. FDA

    PharmaEngine, Inc. recently announced that its licensing partner, Merrimack Pharmaceuticals, Inc. has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection) to the U.S

  3. Celgene To Acquire Quanticel Pharmaceuticals

    Celgene Corporation and Quanticel Pharmaceuticals, Inc., a privately held biotechnology company focused on cancer drug discovery, recently announced a definitive share purchase agreement under which Celgene Corporation will acquire Quanticel

  4. Lilly's CYRAMZA® (ramucirumab) Receives Fourth FDA Approval

    Eli Lilly and Company (NYSE: LLY) has received its fourth U.S. Food and Drug Administration (FDA) approval for CYRAMZA® (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

  5. FDA Grants Orphan Drug Designation For DCR-PH1, Dicerna’s Investigational Therapy For The Treatment Of Primary Hyperoxaluria Type 1 (PH1)

    Dicerna Pharmaceuticals, Inc., a leading developer of RNA interference (RNAi) therapeutics, recently announced that the U.S

  6. Mesothelioma Immunotherapy Vaccine Receives Orphan Drug Designation From FDA, Baron & Budd Reports

    The mesothelioma law firm of Baron & Budd reports the U.S

  7. PPD Honored For Patient-Centric Communications On Clinical Research

    Pharmaceutical Product Development, LLC (PPD) recently announced it has won recognition for a patient-centered communications campaign demonstrating the company’s commitment to helping biopharmaceutical clients deliver life-changing medical treatments

  8. Astellas Pharma And Potenza Therapeutics Partner To Build A Portfolio Of Immuno-Oncology Therapeutics

    Astellas Pharma Inc. and Potenza Therapeutics, Inc., a biotechnology company developing a portfolio of immuno-oncology programs, recently announced an exclusive research and development collaboration

  9. Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer

    Pfizer Inc. announced recently that XALKORI (crizotinib) received Breakthrough Therapy designation by the U.S

  10. Investigational Brain Cancer Vaccine Produces Strong Immunological Response

    A first-of-its kind cancer vaccine, SurVaxM, has demonstrated safety and tolerability in patients with recurrent or progressive malignant brain tumors, according to results of a phase I study conducted by Roswell Park Cancer Institute (RPCI) researchers.

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