Articles By Estel Grace Masangkay

  1. Halozyme Treatment Wins FDA Orphan Status For Pancreatic Cancer 10/7/2014

    Biopharmaceutical company Halozyme Therapeutics reported that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its PEGylated recombinant human hyaluronidase (PEGPH20) as treatment for pancreatic cancer.

  2. Pendopharm To Market Sigmoid's CyCol For UC In Canada 10/3/2014

    Irish specialty pharmaceutical firm Sigmoid Pharma announced that it has signed an agreement with Canadian firm Pendopharm for the marketing of CyCol for ulcerative colitis in Canada.

  3. Roche Posts Positive Results For Two-Pill Combo In Melanoma 10/1/2014

    Roche’s subsidiary Genentech reported positive results from its Phase 3 trial investigating its combination treatment cobimetinib plus Zelboraf (vemurafenib) in patients with advanced melanoma.

  4. AstraZeneca's EU Label Update For Iressa Backed By CHMP 10/1/2014

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave its positive recommendation for a Type 2 variation update to the EU label of AstraZeneca’s Iressa (gefitinib) to include blood-based diagnostic testing.

  5. Roche's Perjeta Regimen In Breast Cancer An “Unprecedented Success” 9/30/2014

    Roche reported the final survival results from its Phase 3 study of Perjeta (pertuzumab), which showed that the drug extended the overall survival (OS) of women with previously untreated HER2-positive metastatic breast cancer (mBC) by 15.7 months.

  6. AstraZeneca Sells Off 17 Retired Injectables To IGI Labs 9/29/2014

    Specialty generic drug maker IGI Laboratories announced that it has acquired the regulatory rights to 18 formerly marketed products from British drug firm AstraZeneca.

  7. Acorda To Acquire Civitas Therapeutics For $525M 9/26/2014

    Acorda Therapeutics announced that it has agreed to acquire Civitas Therapeutics for $525 million. The agreement opens the door for Acorda to Civitas’ CVT-301, an investigational treatment for Parkinson’s disease currently undergoing Phase 3 development.

  8. FDA Fast Tracks Galmed's Aramchol For Liver Disorder 9/25/2014

    Clinical stage biopharmaceutical firm Galmed Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to aramchol for the treatment of Non-Alcoholic Steato-Hepatitis (NASH).

  9. Breath Strips Inspire Research Into Heat-Resistant Vaccines 9/25/2014

    A team of scientists with the Biointerfaces Institute at McMaster University has received a grant award of $100,000 from Grand Challenges Canada for their research in heat-resistant vaccines for low-income countries.

  10. Inovio Expands HPV Immunotherapy To Aerodigestive Cancers 9/24/2014

    Inovio Pharmaceuticals announced it has expanded the clinical development of its HPV immunotherapy INO-3106 to include a Phase 1 study in aerodigestive cancers. Positive results from the trial could open the door to an orphan drug designation from the U.S. Food and Drug Administration (FDA), the company said.