FDA plans to curb tobacco deaths with new regulation
The U.S. Food and Drug Administration is creating new regulation on tobacco and nicotine to reduce diseases and death brought on by tobacco use. Read More »
Eagle Pharmaceuticals receives FDA reply for Ryanodex
In answer to New Jersey-based Eagle Pharmaceuticals Inc.’s New Drug Application (NDA) for Ryanodex (dantrolene sodium) to treat exertional heat stroke (EHS), the U.S. Food and Drug Administration (FDA) recently issued a Complete Response Letter. Read More »
Biologics named limited distributor of Nerlynx
Los Angeles-based Puma Biotechnology Inc.’s FDA-approved Nerlynx (neratinib) tablets — a kinase inhibitor developed to treat breast cancer — will be circulated by Cary, North Carolina’s Biologics Inc. as per a limited distribution agreement between the companies. Read More »
Teligent's topical erythromycin gel receives FDA approval
New Jersey-based specialty generic pharmaceutical manufacturing firm Teligent recently obtained U.S. Food and Drug Administration approval — its third in 2017 — for its Abbreviated New Drug Application (ANDA) regarding its Erythromycin Topical Gel USP, 2%. Read More »
Vizient releases Drug Price Forecast for 2018
Vizient Inc. recently released its July 2017 Drug Price Forecast, which provides pharmacy leaders and health system executives with insights on pricing and practice changes throughout the pharmaceutical industry. Read More »
EnvisionRx receives renewed accreditation from URAC
EnvisionRx, a pharmacy benefit manager (PBM) and division of EnvisionRxOptions, a wholly owned subsidiary of Rite Aid Corporation, recently announced that the health care accrediting organization URAC renewed the company’s accreditation for pharmacy benefit management. Read More »
Gilteritinib gains orphan-drug status to combat AML
Because acute myeloid leukemia (AML) impacts relatively few individuals nationwide, gilteritinib — an anti-cancer medication developed by Tokyo-based Astellas Pharma Inc. — recently attained orphan-drug designation from the U.S. Food and Drug Administration. Read More »
Pfizer's Avastin biosimilar meets primary endpoint in study
Pfizer Inc. recently announced positive results for its Reflections B7391003 study, which evaluated the safety and efficacy of PF-06439535 as compared to Avastin (bevacizumab). Read More »
Eisai's supplemental application for Fycompa CIII accepted
Eisai Inc.'s supplemental New Drug Application for Fycompa CIII has been accepted by the U.S. Food and Drug Administration. Read More »
Thermo Fisher adds mini implant line to its drug implant development line
Thermo Fisher Scientific Inc. recently announced the availability of a fully integrated solution for polymer-based drug implant development and production using hot melt extrusion (HME). Read More »
Lexicon and Ipsen's MAA for Xermelo given positive opinion by CHMP
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 »
Merck launches Renflexis as biosimilar with FDA consent
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 acquires rights to sell Custodiol HTK Solution
Accord Healthcare has acquired Essential Pharmaceuticals, a New Jersey company that provides products, services and contributions to transplant medicine. Read More »
European agency approves Tocagen's treatment for high grade glioma
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 »
Health Canada to review Sunovion's schizophrenia treatment
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 Corp.'s c. difficile assay attains FDA clearance
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 »
Chinese officials accept study application for GBM treatment
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 »
FDA accepts Amgen’s BLA for Aimovig (erenumab)
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 »
FDA clears first neonatal MRI device
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 »
Good Neighbor Pharmacy network adds fee estimator tool
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 »
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