Drug Trials Snapshots: TAZVERIK
TAZVERIK is a drug used to treat a type of cancer called advanced epithelioid sarcoma. It is to be used in patients 16 years and older when cancer has spread and cannot be completely removed by surgery. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 4, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry
Clinical/Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 4, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel coronavirus: Advice for primary care and Community settings including pharmacy (England)
The Chief Medical Officer for England has issued an alert that highlights the advice for primary care and pharmacies relating to the evolving situation regarding the novel coronavirus (2019-nCoV). (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - February 4, 2020 Category: Drugs & Pharmacology Source Type: news

Monoferric (Ferric Derisomaltose Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 4, 2020 Category: Drugs & Pharmacology Source Type: news

Octaplas (Pooled Plasma (Human) Solvent/Detergent) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 4, 2020 Category: Drugs & Pharmacology Source Type: news

Numbrino (Cocaine Hydrochloride Nasal Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 4, 2020 Category: Drugs & Pharmacology Source Type: news

Cladribine Oral Tablets (10mg) for Multiple Sclerosis
Title: Cladribine Oral Tablets (10mg) for Multiple SclerosisCategory: MedicationsCreated: 2/4/2020 12:00:00 AMLast Editorial Review: 2/4/2020 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - February 4, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Novel Pandemic Influenza Vaccine FDA Approves Novel Pandemic Influenza Vaccine
Audenz (Seqirus) is the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.FDA Approvals (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - February 4, 2020 Category: Drugs & Pharmacology Tags: Infectious Diseases News Alert Source Type: news

In Drugs
This is region content for the Site Studio Web Site Section 'In Drugs', Region 'MainContent' (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Color Additive Status List
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
Summary of Color Additives Listed for Use in the United States in Foods, Drugs, and Medical Devices (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine
HOLLY SPRINGS, N.C., Feb. 3, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved Audenz™ (Influenza A (H5N1) Monovalent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Tofacitinib Maintenance Dose for Patients With UC Tofacitinib Maintenance Dose for Patients With UC
This study analyzed the efficacy and safety of two adjustments of tofacitinib maintenance dosing for patients with ulcerative colitis.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 3, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Public Workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosimilars - 03/09/2020 - 03/09/2020
The purpose of the public workshop is to discuss FDA and FTC ’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: JEUVEAU
Drug Trials Snapshot (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Laboratory Tests | Metformin
FDA continues to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in metformin approved for sale in the U.S. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Updates and Press Announcements on NDMA in Metformin
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Information about Nitrosamine Impurities in Medications
General questions and answers and general information for patients, health care providers and industry (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees
Draft guidance for the public, FDA advisory committee members, and FDA staff: Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Magellan Rx Pharmacy, LLC - 536134 - 06/06/2019
Drug Product/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Kings Park Slope Inc. - 439314 - 11/15/2019
Compounding Pharmacy/Adulteration/Misbranding (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Janssen to Highlight Depth of Solid Tumor Portfolio at ASCO GU
RARITAN, N.J., February 3, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple data presentations from a robust solid tumor portfolio that will be featured at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place February 13-15 in San Francisco. Company-sponsored data presentations will include clinical results for ERLEADA® (apalutamide) and niraparib in prostate cancer; and BALVERSA™ (erdafitinib) in bladder cancer. “We are committed to improving outcomes in patients with prostate and bladder cancer where high unmet...
Source: Johnson and Johnson - February 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Class 2 medicines recall: Ranitidine 150mg and 300mg tablets
Medreich Plc is recalling all unexpired stock of ranitidine 150mg and 300mg tablets from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosod (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Ixifi (Infliximab-qbtx for Injection, for Intravenous Use ) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Tepezza (Teprotumumab-trbw for Injection, for Intravenous Use) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Tazverik (Tazemetostat Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Jencycla (Norethindrone Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Econazole Nitrate Cream (Econazole Nitrate Cream) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Rybelsus (Semaglutide Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 2, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Release of ORA Laboratory Analytical Results to the Responsible Party
This document provides guidance for FDA staff regarding the release of final and, in some circumstances, preliminary Office of Regulatory Affairs (ORA) laboratory analytical results to the responsible party. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 1, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination
Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, ex (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 1, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Industry funding of patient groups common and lacks transparency
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Latest treatment options for Scotland's NHS
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Add-on daratumumab not cost effective in RRMM
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Abuse-deterrent formulation of morphine saves healthcare costs
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

PrEP more cost  effective in patients at high risk of HIV infection
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Novel device for preventing contrast-induced kidney injury cost saving
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Burden of care-giving in epilepsy substantial in the US
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Thrombectomy saves costs after stroke with large vessel occlusion
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Fixed dosage regimen of nivolimab increases costs
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Cystic fibrosis drug funding in NZ − have your say
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

CVD burden in T1DM substantial in the US
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

ICER updates methods and procedures to maximise engagement
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Potential cost impact of single-payer healthcare system in USA
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Transitional care services cost effective after hospitalisation for HF
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Maternal and neonatal tetanus elimination requires financial investment
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

NICE broadening data sources for guidance
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Assessing the optimal imaging approach for suspected appendicits
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news

Progesterone cost effective in preventing miscarriage
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - February 1, 2020 Category: Drugs & Pharmacology Source Type: news