Ultomiris (Ravulizumab-cwvz Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 31, 2018 Category: Drugs & Pharmacology Source Type: news

Liquid Biopsy Tracks Herceptin Resistance in HER2+ Gastric Cancer Liquid Biopsy Tracks Herceptin Resistance in HER2+ Gastric Cancer
Circulating tumor DNA profiling can provide novel insights into gene alterations that underlie trastuzumab resistance in HER2+ metastatic gastric cancer.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - December 27, 2018 Category: Drugs & Pharmacology Tags: Hematology-Oncology News Source Type: news

Influence of HCV Eradication With DAAs on Gut Microbiota Influence of HCV Eradication With DAAs on Gut Microbiota
How does HCV infection eradication with DAA therapy modify gut microbiota composition, and what impact might that have on liver disease-associated outcomes?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 27, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns
DUBLIN--(BUSINESS WIRE)--Dec. 27, 2018-- Horizon Pharma plc (NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for Ravicti (glycerol... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine
BRIDGEWATER, N.J. and KENILWORTH, N.J.– December 26, 2018–The U.S. Food and Drug Administration has approved Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 27, 2018 Category: Drugs & Pharmacology Source Type: news

Kala Pharmaceuticals Announces New Drug Application for KPI-121 0.25% for Dry Eye Disease Has Been Accepted for Review by the U.S. Food and Drug Administration
WALTHAM, Mass.--(BUSINESS WIRE)--Dec. 26, 2018-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFY™ mucus-penetrating particle... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 26, 2018 Category: Drugs & Pharmacology Source Type: news

Cochrane's 30 under 30: Heidi Gardner
Cochrane is made up of  13,000 members and over 50,000 supporters come from more than 130 countries, worldwide. Our volunteers and contributors are researchers, health professionals, patients, carers, people passionate about improving health outcomes for everyone, everywhere.Cochrane is an incredible community of people who all play their part in improving health and healthcare globally. We believe that by putting trusted evidence at the heart of health decisions we can achieve a world of improved health for all.  Many  of our contributors are young people working with Cochrane ...
Source: Cochrane News and Events - December 24, 2018 Category: Information Technology Authors: Lydia Parsonson Source Type: news

Zevalin (Ibritumomab Tiuxetan) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 24, 2018 Category: Drugs & Pharmacology Source Type: news

Braeburn Announces Tentative FDA Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa.— December 23, 2018— Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of Brixadi (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors
JERUSALEM--(BUSINESS WIRE)--Dec 21, 2018--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson ’s Disease
ARDSLEY, N.Y.--(BUSINESS WIRE) December 21, 2018 --Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration approved Inbrija™ for intermittent treatment of OFF episodes in people with Parkinson’s disease... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Brexit update: further no-deal guidance from DHSC
The Government has today sent new EU Exit Operational Readiness Guidance to allhealth and care providers as part of the Department’s work to increase preparations for a possible no-deal Brexit. (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Jazz Pharmaceuticals Receives New PDUFA Goal Date for Solriamfetol for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
DUBLIN, Dec. 21, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Elzonris (tagraxofusp-erzs), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy
NEW YORK, December 21, 2018 (GLOBE NEWSWIRE)– Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Aimmune Therapeutics Submits BLA to FDA for AR101 for the Treatment of Peanut Allergy in Children and Adolescents Ages 4 –17
BRISBANE, Calif.--(BUSINESS WIRE)--Dec. 21, 2018-- Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that it has submitted a Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ultomiris (ravulizumab-cwvz) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
BOSTON--(BUSINESS WIRE)-- December 21, 2018 -- Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Direct-acting antivirals for chronic hepatitis C: risk of hypoglycaemia in patients with diabetes
Medicines and Healthcare products Regulatory Agency(MHRA) has issued a safety alert advising to monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepa (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Metformin vs. Janumet
Title: Metformin vs. JanumetCategory: MedicationsCreated: 12/21/2018 12:00:00 AMLast Editorial Review: 12/21/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Altace Capsules (Ramipril Capsules) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Altace (Ramipril Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne
REHOVOT, Israel and BRIDGEWATER, N.J., Dec. 21, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)
On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Pharmaxis Announces Resubmission of Bronchitol NDA
Sydney, Australia -- December 20, 2018 -- Pharmaceutical research company Pharmaxis (ASX: PXS) today announced the resubmission of the Bronchitol New Drug Application with the United States Food and Drug Administration (FDA) by its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Initiates Rolling New Drug Application to FDA for Pedmark
Research Triangle Park, NC, December 20, 2018– Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, following a pre-submission meeting with the oncology division of the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Metformin vs. Lantus
Title: Metformin vs. LantusCategory: MedicationsCreated: 12/20/2018 12:00:00 AMLast Editorial Review: 12/20/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Migergot (Ergotamine Tartrate and Caffeine Suppositories) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Synojoynt (1% Sodium Hyaluronate Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Heather (Norethindrone Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Pentam 300 (Pentamidine Isethionate for Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Medical Interventions for Moderate-to-Severe UC and HrQoL Medical Interventions for Moderate-to-Severe UC and HrQoL
This meta-analysis compared the effects of currently available biological therapies on quality of life in patients with moderate-to-severe ulcerative colitis.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 20, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

AbbVie Submits New Drug Application to U.S. FDA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis
NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Current concepts and perspectives on connexin43: A mini review
(Bentham Science Publishers) This review discusses current knowledge on the functional and structural abnormalities in Cx43 associated with heart disease and cancer, aiming to highlight the importance of this connexin as an emerging therapeutic target. Here, the current knowledge on the pharmacology of Gap Junction Channels and Hemichannels were also summarized. Finally, we propose that this knowledge can be exploited to identify new diagnostic and effective therapeutic approaches for ischemic heart disease and cancer (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - December 20, 2018 Category: Biology Source Type: news

Nabriva Therapeutics Submits New Drug Applications to U.S. Food and Drug Administration for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults
DUBLIN, Ireland, Dec. 20, 2018 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
CAMBRIDGE, Mass., Dec. 20, 2018 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, announced today that it has completed the submission of its rolling New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

Assertio Therapeutics Announces Submission of NDA for FDA Approval of Cosyntropin Depot
LAKE FOREST, Ill., Dec. 20, 2018 (GLOBE NEWSWIRE) -- Assertio Therapeutics, Inc. (NASDAQ: ASRT) today announced that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for its novel injectable formulation of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 20, 2018 Category: Drugs & Pharmacology Source Type: news

DBV Technologies Provides Update on Viaskin Peanut for Children Four to 11 Years of Age - BLA Withdrawn
December 19, 2018 -- DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) today announced that after discussions with the U.S. Food and Drug Administration (FDA), its Biologics License Application (BLA) for Viaskin... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Hydrocortisone muco-adhesive buccal tablets
should not be used off-label for treating adrenal insufficiency in children due to serious risks. There is a risk of insufficient cortisol absorption and li (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Help your patients quit smoking in 2019
It’s not too late to join in with Public Health England’s Smokefree Health Harms campaign, now in its seventh year. The campaign to help patients quit smoking in the New Year launches on (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Pharmacy Alert: Valproate medicines: are you acting in compliance with the pregnancy prevention measures?
Women continue to report instances when they have not received patient information with their dispensed valproate medicine. The Medicines and Healthcare products Regulatory Agency has issued a drug s (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Metformin vs. Victoza
Title: Metformin vs. VictozaCategory: MedicationsCreated: 12/19/2018 12:00:00 AMLast Editorial Review: 12/19/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Herzuma (Trastuzumab-pkrb for Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 19, 2018 Category: Drugs & Pharmacology Source Type: news

Motegrity (Prucalopride Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 19, 2018 Category: Drugs & Pharmacology Source Type: news