Lexicon Pharmaceuticals Inc.'s Xermelo, a carcinoid syndrome diarrhea treatment created in collaboration with Ipsen, has been given a positive opinion for Marketing Authorization Application by the Committee for Medicinal Products for Human Use, the committee of the European Medicines Agency responsible for human medicines. Read More »
New Jersey-based Merck recently introduced Renflexis (infliximab-abda) in the United States as a biosimilar of Remicade (infliximab) following its FDA approval last April for all eligible indications. Read More »
Accord Healthcare has acquired Essential Pharmaceuticals, a New Jersey company that provides products, services and contributions to transplant medicine. Read More »
Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, recently announced that its Toca 511 was awarded PRIME designation by the European Medicines Agency for treating high grade glioma patients. Read More »
Sunovion Pharmaceuticals Inc. of Marlborough, Massachusetts recently gained approval for its supplemental new drug submission regarding Latuda (lurasidone HCI) — aimed at relieving adolescent schizophrenia — from Health Canada, potentially extending the treatment’s age range. Read More »
Luminex Corporation recently announced that its ARIES clostridium difficile (c. difficile) assay has been given U.S. Food and Drug Administration (FDA) clearance. Read More »
DelMar Pharmaceuticals' application for a Phase II study evaluating a treatment for newly diagnosed MGMT-unmethylated glioblastoma multiforme has been accepted by the Human Genetic Resources Administration of China. Read More »
California-based Amgen recently obtained U.S. Food and Drug Administration (FDA) acceptance of its Biologics License Application (BLA) for Aimovig (erenumab), a product developed specifically to help victims of frequent migraine headaches. Read More »
To better tend babies in the nation’s neonatal intensive care units, the first magnetic resonance imaging (MRI) device designed for newborns recently garnered U.S. Food and Drug Administration approval following thorough safety confirmation. Read More »
Pharmaceutical provider AmerisourceBergen recently unveiled the DIR Fee Estimator, its newest tool in conjunction with its nationwide Good Neighbor Pharmacy network, to streamline transactions between provider networks and pharmacy benefit managers by providing cost estimate ranges. Read More »
Sanofi and Regeneron Pharmaceuticals Inc. recently announced that Kevzara (sarilumab), a treatment for adult patients with moderately to severely active rheumatoid arthritis who have not responded well to one or more disease modifying antirheumatic drugs, has been approved by the U.S. Food and Drug Administration. Read More »
Therigy, a company that pioneered patient-focused specialty therapy management, recently announced a strategic partnership with EPI-Q Inc. to expand research on specialty pharmacy outcomes. Read More »
Amgen and UCB recently announced that their Evenity study, which analyzed the drug as a treatment for postmenopausal women with osteoporosis, met both primary endpoints and the secondary endpoint. Read More »
Biologics Inc., a McKesson Specialty Health oncology pharmacy services company, has been chosen by AstraZeneca to distribute Imfinzi. Read More »
Xynomic Pharma's has initiated a strategic partnership with the University of California San Francisco for a PAX Study – a multi-national, multi-center, randomized Phase 2/3 study of Pazopanib plus Abexinostat, as opposed to Pazopanib monotherapy in patients with locally advanced or metastatic renal cell carcinoma. Read More »
Sun Pharmaceutical Industries Ltd.'s Biologics License Application for tildrakizumab has been accepted by the U.S. Food and Drug Administration. Read More »
Pfizer Inc.'s proposed epoetin alfa biosimilar has been recommended for approval across all indications by the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee. Read More »
EMD Serono, the biopharmaceutical business of Merck KGaA in the United States and Canada, recently showcased 14 presentations at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers, including eight sets of data on Cladribine Tablet, a treatment for patients with relapsing multiple sclerosis. Read More »
Novartis' Zykadia, a treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, has been approved for expanded use by the U.S. Food and Drug Administration. Read More »
Optum, UnitedHealth Group’s health services business, and Merck recently announced collaboration on developing and simulating the performance of contractual reimbursement models that align payment for prescription drugs with patient health outcomes. Read More »
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