FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia
New pleuromutilin antibiotic IV and oral tablets.
FDA Approves Upadacitinib for Severely Active RA
Humira successor indicated for adults with inadequate response or intolerance to methotrexate.
Florida Declares Hepatitis A Public Health Emergency
2019 cases greater than five-year trend.
FDA Approves Turalio (Pexidartinib) for TGCT
Kinase inhibitor oral capsules.
New Warnings for Tofacitinib Issued by FDA
Black box warns of increased risk of blood clots and death.
CPF and CPESN USA: Flip the Pharmacy
New program to fund community pharmacy reinvention efforts.
FDA Approves Hadlima (Adalimumab-bwwd) Biosimilar
TNF blocker biosimilar to Humira (adalimumab, Abbvie).
FDA Approves Ruxience, a Rituxan Biosimilar
CD20-directed antibody indicated for several cancers and other conditions.
First Generic Lyrica Capsules Approved by FDA
Distributed by Invagen, a subsidiary of Cipla Ltd.
FDA Approves Otezla (Apremilast) to Treat Oral Ulcers
Fourth indication for the drug since 2014.
FDA Approves Recarbrio for UTI and Intra-Abdominal Infections
Combination drug indicated for infections caused by susceptible gram-negative bacteria.
Gadavist (Gadobutrol) Approved as First Cardiac MRI Contrast Agent
Fourth approval for use in assessing myocardial perfusion and late gadolinium enhancement.
Opicapone (Ogentys) for Parkinson’s Disease
COMT inhibitor to be used as an adjunctive treatment to levodopa/carbidopa.
Major Chains to Dominate Expanding CBD Market
CBD market will grow by over 700% in 2019.
FDA Approves Xpovio (Selinexor) for Multiple Myeloma
Nuclear export inhibitor indicated in combination with dexamethasone.
Drug Shortages: Impact on U.S. Health Systems
$359 million per year, and nearly 40 cumulative hours per week are spent mitigating shortages.
FDA Issues Warning Letters to Companies Selling Kratom Products
Unsupported claims of safety and effectiveness have concnerned the FDA.
FDA Approves Avastin Biosimilar, Zirabev (Bvacizumab-bvzr), for Various Cancers
Bevacizumab-bvzr is an mAb endothelial growth factor biosimilar.
FDA Approves Soliris (Eculizumab) for Neuromyelitis Optica Spectrum Disorder
Complement inhibitor is the first treatment for the rare autoimmune disorder.
FDA Approves Dupixent (Dupilumab) for Chronic Rhinosinusitis
First treatment approved for the condition with nasal polyps.
FDA Approves New Somatuline Depot Syringe
New features to ease injection administration.
Pharm Tech Certification Board Awards Grants to Four State Pharmacy Associations
Funds to help establish education and training for pharmacy technicians.
FDA Approves Victoza for Pediatric Type-2 Diabetes
First non-insulin drug for pediatric use approved in nearly 20 years.
FDA Approves Kanjinti for HER2 Cancers
Indications include breast cancer, metastatic gastric cancer, and metastatic gastroesophageal junction adenocarcinoma.
Pharmacy Organizations Issue Letter on DIR Fees
DIR abuse might require Presidential and Congressional intervention.
FDA Approves Polivy for Large B-Cell Lymphoma
Drug targets the CD79b protein on B-cells.
New Emergency Medicine Certificate from ASHP
Pharmacists can earn up to 27 hours of CE.
Hospital Drug Diversion: An Underreported Threat
Results of a recent survey suggest employee-based drug abuse is a concern for many healthcare providers, though they don’t believe it can happen in their facilities.
FDA Approves Zerbaxa for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
Zerbaxa is a cephalosporin antibacterial and beta-lactamase inhibitor combination drug originally approved for abdominal and urinary tract infections.
FDA Approves First Drug to Treat Episodic Cluster Headaches in Adults
Patients on Emgality experienced an average of 8.7 fewer weekly episodic cluster headaches.