Articles By Estel Grace Masangkay

51. EMA Accepts Merck's Pembrolizumab MAA For Review 7/3/2014
    Merck reported that its Marketing Authorization Application (MAA) for its investigational anti PD-1 antibody pembrolizumab has been accepted for review by the European Medicines Agency (EMA). If approved, the drug could possibly be the first anti PD-1 therapy in the EU.
52. Sanofi And Takeda Partner In Diabetes Patient Care In Japan 7/2/2014
    Sanofi and Takeda Pharmaceutical announced that the companies have signed into an alliance to establish a collaborative system in the field of diabetes awareness and education in Japan.
53. Pfizer And Tabuk Enter Commercial Agreement In Saudi Arabia 7/2/2014

    Last week, Tabuk Pharmaceuticals announced that it has entered into a key commercial agreement with Pfizer—one that will help Tabuk strengthen its position in the Saudi Arabian market. As part of the agreement, Pfizer will grant exclusive rights to Tabuk to carry out manufacturing processes under the commercial license. Tabuk will also distribute second brand versions of four of Pfizer’s products in the kingdom of Saudi Arabia. The partnership will target the areas of cardiovascular, central nervous system, respiratory, and anti-infective therapeutics in the Kingdom.

54. BMS Issues Voluntary Recall Of 6 Lots Of Coumadin 7/2/2014

    Bristol-Myers Squibb said that is voluntarily recalling six lots of Coumadin 5 mg single use vials for injection in the U.S. due to suspected particulate matter.

55. Ontario Brain Institute Awards Research Grant To EastGate Acquisitions 7/1/2014
    EastGate Acquisitions announced that it has received a research grant from the Ontario Brain Institute for the development of its Lorazepam Spray as treatment for epileptic seizures in outpatient settings.
56. Ligand Ally GSK Kick-Starts Eltrombopag Phase 3 Study In MDS 7/1/2014
    Ligand Pharmaceuticals reported that its collaborator GlaxoSmithKline has initiated a Phase III study investigating the platelet supportive care effect of eltrombopag in combination with current standard of care azacitidine in intermediate-1, intermediate-2 or high-risk patients with myelodysplastic syndromes (MDS).
57. FDA Approves Inhaled Insulin Afrezza For Diabetes 7/1/2014

    The U.S. Food and Drug Administration (FDA) has granted approval to MannKind Corporation’s Afrezza (insulin human) Inhalation Powder for the improvement of glycemic control in adult patients with diabetes mellitus.

58. Bayer's Diabetic Macular Edema Drug Receives CHMP Positive Opinion 7/1/2014
    Bayer Healthcare announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for approval in the EU of the company’s aflibercept solution for injection into the eye to treat vision damage caused by diabetic macular edema.
59. CHMP Backs Bristol-Myers Squibb's Daclatasvir For Hep C In EU 7/1/2014
    Bristol-Myers Squibb reported that it has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adult patients in the EU.
60. Boehringer Ingelheim Widens Access To IPF Drug Nintedanib 6/26/2014

    Boehringer Ingelheim announced that it has launched an open-label, multi-center expanded access program (EAP) in the U.S. for its investigational compound nintedanib. The drug will be available patients diagnosed with idiopathic pulmonary fibrosis (IPF).