TAKEDA PHARMACEUTICAL COMPANY: Takeda Highlights Favorable Safety Profile of Entyvio® (vedolizumab) Through Comparative Real-World Data Versus TNFα-Antagonist Therapy in Ulcerative Colitis and Crohn’s Disease

Takeda Pharmaceutical Company Limited [TSE:4502] (“Takeda”) today announced a new analysis of real-world data comparing the safety data of the gut-selective biologic Entyvio® (vedolizumab) and tumor necrosis factor-alpha (TNFα)-antagonist therapy. Read More »

PURDUE PHARMA L.P.: Positive New Data on Investigational Lemborexant Presented at 32nd Annual SLEEP Meeting

Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, “Purdue Pharma”) today presented the results of two key Phase 1 clinical studies of their investigational sleep/wake regulation agent lemborexant at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018), June 2-6, Baltimore, MD. Lemborexant is currently being studied for the potential treatment of multiple sleep disorders. Read More »

PORTOLA PHARMACEUTICALS: New Interim Phase 2a Study Results Demonstrate Broad Clinical Activity of Portola Pharmaceuticals’ Oral SYK/JAK Inhibitor Cerdulatinib

Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced new interim results from the Company’s ongoing Phase 2a study of cerdulatinib, an investigational, oral SYK/JAK inhibitor, in patients with specific subtypes of B-cell and T-cell Non-Hodgkin Lymphoma (NHL), including relapsed/refractory follicular lymphoma (FL) and peripheral T-cell lymphoma (PTCL), and chronic lymphocytic lymphoma/small lymphocytic lymphoma (CLL/SLL). Read More »

CELEGENE CORPORATION: Results of Phase III RELEVANCE Study Comparing REVLIMID plus Rituximab (R²) Versus Rituximab Plus Chemotherapy in Patients with Previously Untreated Follicular Lymphoma to be Presented at ASCO 2018

Celgene Corporation (NASDAQ:CELG) today announced additional results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented at the 54th Annual American Society of Clinical Oncology Scientific Sessions (ASCO) in Chicago, Illinois on June 1-5, 2018. Read More »

DAIICHI SANKYO, INC: Daiichi Sankyo Presents Preliminary Phase 1 Data for Antibody Drug Conjugate U3-1402 in Patients with HER3-Expressing Breast Cancer at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that preliminary data from the dose escalation part of an ongoing phase 1/2 study with investigational U3-1402 in heavily pretreated patients with HER3-positive metastatic breast cancer will be presented during a Poster Discussion Session on Monday, June 4 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (Abstract 2512; 3:00 – 4:15 PM CDT). Read More »

BRISTOL-MYERS SQUIBB: U.S. Food and Drug Administration Lifts Partial Clinical Hold on Opdivo (nivolumab)-based Combination Study in Multiple Myeloma

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Read More »

ASTRAZENECA PHARMACEUTICALS LP: Moxetumomab pasudotox pivotal data in patients with previously-treated hairy cell leukaemia presented at the 2018 ASCO meeting

AstraZeneca and MedImmune, its global biologics research and development arm, today presented results from the Phase III (‘1053’) clinical trial that evaluated moxetumomab pasudotox in 80 patients with relapsed or refractory hairy cell leukaemia (HCL) who had received at least two prior lines of therapy. Read More »

ABBVIE: Phase 3 IMBRUVICA® (ibrutinib) Data Suggest Improved Treatment Outcomes in Waldenström's Macroglobulinemia (WM), a Rare Form of Blood Cancer, in Combination with Rituximab versus Rituximab Alone

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced findings from an interim analysis of the Phase 3 iNNOVATE (PCYC-1127) study evaluating IMBRUVICA® (ibrutinib) plus RITUXAN® (rituximab) in previously untreated and relapsed/refractory patients with Waldenström's macroglobulinemia (WM), a rare type of non-Hodgkin's lymphoma (NHL). Read More »

ASTELLAS PHARMA US, INC.: U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company's New Drug Application (NDA) for gilteritinib for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved tes Read More »

AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS: Widespread Unavailability of Critical Medications Jeopardizes Patient Care in U.S. Hospitals

ASHP (American Society of Health-System Pharmacists), the 45,000-member national association representing pharmacists who serve as patient care providers in acute and ambulatory care settings, is calling for swift action from policymakers to address the persistent shortages of critical medications in hospitals and health systems. Read More »

ALLERGAN, INC.: Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Read More »

EISAI: Eisai And Merck Provide Update on Supplemental New Drug Application (sNDA) for Lenvatinib in First-Line Unresectable Hepatocellular Carcinoma

Eisai Inc. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for lenvatinib for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read More »

ASTRAZENECA PHARMACEUTICALS LP: Imfinzi significantly improves overall survival in the Phase III PACIFIC trial for unresectable Stage III non-small cell lung cancer

AstraZeneca and MedImmune, its global biologics research and development arm, today announced positive overall survival (OS) results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). Read More »

AMGEN INC.: FDA Approves Prolia® (Denosumab) For Glucocorticoid-Induced Osteoporosis

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Read More »