Articles By Cyndi Root

  1. FDA Grants Orphan Drug Status to Alexion's Soliris For Myasthenia Gravis 6/19/2014
    Alexion Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Soliris (eculizumab) for Myasthenia Gravis (MG). Patients with MG experience a disabling neurologic disorder caused by uncontrolled complement activation due to antibodies directed at the neuromuscular junction. Martin Mackay, Ph.D., Executive Vice President, Global Head of R&D at Alexion, said, “By specifically inhibiting the terminal complement pathway, which is believed to play a pivotal role in the pathophysiology of MG, we believe that eculizumab has the potential to help patients living with this devastating rare disorder.”
  2. Sanofi and Medtronic Form Alliance In Open-Innovation Model For Diabetes Treatments 6/19/2014
    Sanofi announced in a press release that it has formed an open-innovation alliance with Medtronic to collaborate on diabetes treatments. The two companies wrote a Memorandum of Understanding, which states its aim to improve patient outcomes and quality of life. Initially, the two will focus on simplified insulin treatment, drug-device combinations, and care management that improves adherence. The alliance pairs Medtronic’s insulin pumps and glucose monitoring expertise with Sanofi’s insulin portfolio and drug development experience.
  3. Immunomedics Receives FDA Orphan Drug Status For IMMU-132 In Pancreatic Cancer 6/13/2014

    Immunomedics announced in a press release that the Food and Drug Administration (FDA) has granted Orphan Drug status to IMMU-132. The antibody-drug conjugate (ADC) is for the treatment of pancreatic cancer. The FDA previously granted orphan drug status to IMMU-132 for small-cell lung cancer. Orphan status confers developmental advantages and marketing exclusivity, among other benefits.

  4. Kite Pharma Licenses TCR Candidates From NIH 6/12/2014
    Kite Pharma announced in a press release that it has licensed T Cell Receptor (TCR)-based product candidates from the National Institutes of Health (NIH). Kite, a clinical-stage biotechnology company, focuses on engineered autologous T cell therapy (eACT) products for cancer. The license is an exclusive, worldwide license for intellectual property related to TCR candidates targeting the NY-ESO-1 antigen in cancers.
  5. Roche Acquires Genia Technologies For DNA Sequencing Platform 6/10/2014
    Roche announced in a press release that it has acquired Genia Technologies, which is currently developing a DNA sequencing platform. The single-molecule, semiconductor based platform uses nanopore technology. Roche expects the technology to reduce the price of sequencing, increase speed, and increase sensitivity.
  6. Biotech Firms Launch KPI Therapeutics Consortium For Drug Development 6/10/2014

    A group of five biotech firms, KPI Therapeutics, announced in a press release that it has created a “new paradigm” to develop drugs. The five firms launched the new entity to advance high-impact, novel drugs with unmet needs. Members are MPI Research, Chimera Biotec, Life Chemicals, Medical Marketing Economics (MME), and Kineta. Also included in the group are private equity investors with the funding to begin KPI operations.

  7. FDA Approves And U.S. District Court Affirms Teva's Generic Celebrex 6/3/2014
    Last week, the Food and Drug Administration (FDA) announced in a press release that it has approved the first generic versions of Celebrex (celecoxib) capsules.
  8. Pfizer Partners With Avon Foundation To Award Grants For Metastatic Breast Cancer Awareness Efforts 6/3/2014

    Pfizer announced in a press release that it has formed a partnership with the Avon Foundation for Women. The two have established the Avon-Pfizer Metastatic Breast Cancer Grants Program to provide funding for projects that increase public awareness of metastatic breast cancer and provide support for those living with the disease. Pfizer saw the need for the collaboration when the results of a nationwide survey that it commissioned indicated that more than 60 percent of people know very little about breast cancer.

  9. Ligand Pharmaceuticals To License Five Programs to Viking Therapeutics 5/28/2014

    Ligand Pharmaceuticals announced in a press release that it has licensed five drug candidates and programs to Viking Therapeutics. The licensed agents are treatments for type 2 diabetes, muscle wasting, anemia, and dyslipidemia.

  10. Teva and Active Biotech Committed To Nerventra Development Following CHMP Decline 5/28/2014

    Teva Pharmaceutical Industries and Active Biotech announced in a press release that they are committed to developing Nerventra (laquinimod) despite the Committee for Medicinal Products for Human Use’s (CHMP) refusal to approve it in the European Union (EU). The announcement came after CHMP reaffirmed its January decision to recommend against approval. The immunomodulator treatment is for relapsing-remitting multiple sclerosis (RRMS). The two companies intend to review the decision and determine the next steps.