Articles By Estel Grace Masangkay

  1. CHMP Backs Italian Firm Newron's Xadago For Parkinson's In EU 12/26/2014

    Newron Pharmaceuticals, an Italian R&D pharma firm focused on novel CNS and pain treatments, announced together with its partner Zambon that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xadago (safinamide) for the treatment of mid- to late- stage Parkinson’s disease.

  2. Pfizer Begins Duchenne Muscular Dystrophy Drug Phase 2 Trial 12/23/2014

    Pfizer announced that its Phase 2 clinical trial for the investigational compound PF-06252616 in boys with Duchenne muscular dystrophy (DMD) has kicked off with the enrollment of the first patient.

  3. AstraZeneca's Lynparza Approved For Ovarian Cancer In EU 12/23/2014

    British pharma giant AstraZeneca reported that it has received the approval of the European Commission (EC) for its drug Lynparza (olaparib) as a first-in-class therapy for the maintenance treatment of adult patients with advanced BRCA-mutated ovarian cancer.

  4. Pfizer Posts Positive Phase 3 Data For Pregabalin In PHN 12/22/2014

    Pfizer reported top-line results from the Phase 3 study assessing its drug pregabalin controlled-release (CR) formulation as treatment for adult patients with postherpetic neuralgia (PHN).

  5. Auspex Pharma Posts Phase 3 Data For HD-Linked Chorea Drug 12/22/2014

    Auspex Pharmaceuticals announced positive topline results from the Phase 3 registration study investigating its drug candidate SD-809 for chorea in patients suffering from Huntington's Disease (HD).

  6. FDA Approves Novartis' Signifor LAR For Acromegaly 12/18/2014

    Novartis announced the approval of the U.S. Food and Drug Administration (FDA) for its drug Signifor (pasireotide) long-acting release (LAR) as treatment for endocrine disorder acromegaly.

  7. Novartis Posts Afinitor Results In HER2+ Breast Cancer 12/18/2014

    Novartis reported results from the BOLERO-1 trial of its drug Afinitor (everolimus) as combination therapy with Herceptin (trastuzumab) and paclitaxel as first-line treatment in HER2+ advanced breast cancer at the 2014 San Antonio Breast Cancer Symposium (SABCS).

  8. Genentech Files NDA For Two-Pill Combo In Melanoma In U.S. 12/18/2014

    Roche Group member Genentech announced that it has filed the New Drug Application (NDA) for its two-pill combo therapy cobimetinib and Zelboraf (vemurafenib) with the U.S. Food and Drug Administration (FDA) as treatment for BRAF V600 mutation-positive advanced melanoma.

  9. FDA Accepts Relypsa's NDA For Patiromer In Hyperkalemia 12/18/2014

    Relypsa reported that its New Drug Application (NDA) for its drug Patiromer for Oral Suspension (Patiromer FOS) as treatment for hyperkalemia has been accepted by the U.S. Food and Drug Administration (FDA).

  10. Merck Posts Keytruda Data In Triple Negative Breast Cancer 12/17/2014

    Merck presented early-study data for Keytruda (pembrolizumab) in the treatment of advanced triple-negative breast cancer at the 2014 San Antonio Breast Cancer Symposium (SABCS) held this week.