Kuric (ketoconazole) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

Corium, Inc. Announces FDA Filing Acceptance of New Drug Application for Adlarity (donepezil transdermal system) for the Treatment of Alzheimer ’s Disease
MENLO PARK, Calif., January 27, 2020 (GLOBE NEWSWIRE)– Corium, Inc., a commercial-stage biopharmaceutical company leading the development of novel transdermal healthcare products that are intended to provide alternative treatment options for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

Liquidia Submits New Drug Application for LIQ861 (treprostinil) Inhalation Powder to FDA for the Treatment of Pulmonary Arterial Hypertension (PAH)
RESEARCH TRIANGLE PARK, N.C., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq:LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development of products using its proprietary... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 27, 2020 Category: Drugs & Pharmacology Source Type: news

Enhancing drug testing with human body-on-chip systems
(American Friends of Tel Aviv University) Scientists at Tel Aviv University and Harvard University have devised a functioning comprehensive multi-Organ-on-a-Chip (Organ Chip) platform that enables effective preclinical drug testing of human drug pharmacology. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 27, 2020 Category: International Medicine & Public Health Source Type: news

Drug Trial Snapshot: AYVAKIT
AYVAKIT is used to treat adult patients with gastrointestinal stromal tumor (GIST) whose disease: is caused by certain abnormal platelet-derived growth factor receptor alpha (PDGFRA) genes and, cannot be surgically removed or, has spread throughout the body (metastatic GIST). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

On Demand Webinar: Recent Revisions to the ANDA Prioritization MAPP – Jan. 2020
The FDA offers priority review to abbreviated new drug applications (ANDAs) that may have meaningful impact on generic drug access. Priority review means that FDA gives an ANDA submission either (1) a shorter goal date, or (2) an expedited review. For an ANDA submission to be eligible for priority r (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves tazemetostat for advanced epithelioid sarcoma
Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Wuhan novel coronavirus: Advice for the NHS in Wales
There have been reported cases in China of respiratory infections caused by a novel coronavirus, most reported cases are at the mild end of the spectrum, with no confirmed cases in the UK. The Chief (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 24, 2020 Category: Drugs & Pharmacology Source Type: news

Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
Assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to 19 support marketing approval of drugs and biological products2 for the treatment of specific 20 hematologic malignancies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Wuhan novel coronavirus: Advice for the NHS in England
There have been reported cases in China of respiratory infections caused by a novel coronavirus, most reported cases are at the mild end of the spectrum, with no confirmed cases in the UK. The Chief (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 24, 2020 Category: Drugs & Pharmacology Source Type: news

Amazon Pharmacy trademark - We respond
Following the news that Amazon has filed totrademark the name'Amazon Pharmacy' in the UK, Sandra Gidley, President of the Royal Pharmaceutical Society, said:“Whist the public are incr (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 24, 2020 Category: Drugs & Pharmacology Source Type: news

FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials - 02/13/2020 - 02/13/2020
FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 23, 2020-- Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 23, 2020 Category: Drugs & Pharmacology Source Type: news

Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)
Listen to an audio podcast of the January 14, 2020 FDA Drug Safety Communication titled "Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry
Clinical Pharmacology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry
Clinical Pharmacology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Updates to the FP10 NHS Prescription form - England Only
New prescription forms are being introduced in England to help eligible patients correctly claim free NHS prescriptions and avoid penalty charges... (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 23, 2020 Category: Drugs & Pharmacology Source Type: news

Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices
This document provides guidance for the submission of the chemical and technological data that the Food and Drug Administration's Office of Food Additive Safety considers necessary for its evaluation of petitions requesting the listing of color additives for use in food, drugs, cosmetics, or medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Most Clinical Trials Still Don't Report Results Most Clinical Trials Still Don't Report Results
Fewer than half of trials in an analysis met the FDA's 1-year window for reporting results. Unreported results can distort evidence, erode participants'trust, and waste resources.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 23, 2020 Category: Drugs & Pharmacology Tags: Internal Medicine News Source Type: news

Competitive Generic Therapy Approvals
A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement - 01/16/2020 - 01/16/2020
January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

What Will It Take to Lower the Cost of Insulin in the US? What Will It Take to Lower the Cost of Insulin in the US?
Mayo Clinic hematologist S. Vincent Rajkumar breaks down the complexity of the problem and outlines potential solutions.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 22, 2020 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology News Source Type: news

Vedolizumab and Malignancy Incidence Vedolizumab and Malignancy Incidence
This study analyzed the long-term incidence of malignancy with vedolizumab, a gut-selective antibody approved to treat moderate-to-severe Crohn's disease and ulcerative colitis in adults.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 22, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Current Good Manufacturing Practice —Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD & C Act Guidance for Industry
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. ” This revised draft guidance describes FDA's po (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Designating an Orphan Product: Drugs and Biological Products
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

What Do You Think of Faster FDA Approvals? What Do You Think of Faster FDA Approvals?
A new analysis indicates the US Food and Drug Administration is increasingly accepting less data for drug approvals and shortening its reviews.Medscape Reader Polls (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 22, 2020 Category: Drugs & Pharmacology Tags: Family Medicine/Primary Care News Source Type: news

Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy
DUBLIN, Jan. 22, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration on January 21, 2020 seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 22, 2020 Category: Drugs & Pharmacology Source Type: news

Consumer-Directed Broadcast Advertisements
Guidance for Industry - Consumer-Directed Broadcast Advertisements (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Exports Under the FDA Export Reform and Enhancement Act of 1996
Guidance for Industry - Exports Under the FDA Export Reform and Enhancement Act of 1996 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA
Draft guidance for industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

How to Prepare a Pre-Request for Designation (Pre-RFD)
Guidance for Industry: How to Prepare a Pre-Request for Designation (Pre-RFD) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment , Clinical/Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions
Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND; Frequently Asked Questions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Frequently Asked Questions - IRB Registration
Guidance for Institutional Review Boards on IRB Registration Requirements (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cosmelab Co Ltd - 590480 - 01/09/2020
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)
DUBLIN--(BUSINESS WIRE)--Jan. 21, 2020-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved Tepezza (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). Tepezza is the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 21, 2020 Category: Drugs & Pharmacology Source Type: news

Non-local IRB Review
Information Sheet (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cooperative Research
, information sheet (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Charging for Investigational Products
- Information Sheet (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

GOJO Industries Inc - 599132 - 01/17/2020
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2020 Category: Drugs & Pharmacology Authors: Office of Pharmaceutical Quality Operations, Division III Source Type: news

RPS welcomes Pharmacy Advice campaign
The Pharmacy Advice campaign, part of Public Health England'sHelp UsHelp You, has launched to encourage the public to visit community pharmacies for advice on minor illnesses. The campaign seeks (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 21, 2020 Category: Drugs & Pharmacology Source Type: news

Stavzor (Valproic Acid) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 21, 2020 Category: Drugs & Pharmacology Source Type: news

Ayvakit (Avapritinib Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 21, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Evoke Pharma ’s NDA Resubmission for Gimoti
SOLANA BEACH, Calif., Jan. 21, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on the development of drugs to treat gastrointestinal (GI) disorders and diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 21, 2020 Category: Drugs & Pharmacology Source Type: news

New research could reduce the risk of sudden cardiac death
New research has shown that by changing the time course of voltage change early when the heart cell contracts it is possible to both withhold a potentially lethal electrical disturbance and improve the strength of cardiac contraction in heart failure at the same time. (Source: University of Bristol news)
Source: University of Bristol news - January 20, 2020 Category: Universities & Medical Training Tags: Health, International, Research; Faculty of Life Sciences, Faculty of Life Sciences, School of Physiology, Pharmacology and Neuroscience; Press Release Source Type: news

ITV's This Morning: President comments
On Friday 17 January guests on ITV’s This Morning(36 minutes in) commented on the role of pharmacists sparked by the consultation by NICE on how community pharmacists can promote health and well (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 20, 2020 Category: Drugs & Pharmacology Source Type: news

Reported PPI Side Effects: Physician and Patient Perspectives Reported PPI Side Effects: Physician and Patient Perspectives
Are users of proton pump inhibitors changing their behavior based upon concerns regarding side effects? Are physicians changing their management strategies?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 20, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Look what's inside: Full-body movies from EXPLORER scanner
(University of California - Davis) Positron Emission Tomography, or PET scanning, a technique for tracing metabolic processes in the body, has been widely applied in clinical diagnosis and research spanning physiology, biochemistry and pharmacology. Now researchers at UC Davis and Fudan University, Shanghai have shown how to use an advanced reconstruction method with an ultrasensitive total-body PET scanner to capture real-time videos of blood flow and heart function. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 20, 2020 Category: International Medicine & Public Health Source Type: news

FDA Harnesses Technology and Collaboration to Support Rare Disease Product Development
Announcing an Orphan Drug Technology Modernization effort and the 2020 FDA Rare Disease Day meeting, this article discusses upcoming FDA activities to support medical product development for rare diseases. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 17, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility
FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 17, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news