FDA approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules, Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.
FDA has approved parathyroid hormone (Natpara, NPS Pharma) once-daily injection to control hypocalcemia in patients with hypoparathyroidism.
Celiac disease occurs due to a genetic intolerance to dietary ingested gluten peptides. This initiates an immune response, predominantly in the small bowel, that results in malabsorption and associated symptoms including chronic diarrhea with weight loss, steatorrhea, postprandial abdominal pain, and bloating.
Approximately one-third of patients on a novel oral anticoagulant (NOAC) received inappropriate dosing based on indication, renal function, or concomitant interacting medications during hospitalization in the intensive care unit, typically for stroke prevention in atrial fibrillation, according to data presented at the Society of Critical Care Medicine meeting in Phoenix.
It is important to ensure established migraine medications are available for the patients who need them, according to a new study published in the January issue of Headache.
FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of moderate-to-severe plaque psoriasis.
Many studies have shown that nonadherence to medications is associated with numerous adverse outcomes (including hospitalizations, higher costs, and increased mortality).
FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals.
Healthcare providers need to help patients understand how alcohol can interact with their medications, according to a study from the National Institutes of Health and published in the February 2015 issue of Alcoholism: Clinical and Experimental Research.
FDA approved Phoxillum Renal Replacement Solutions.
With a few keystrokes, national diabetes organizations declared millions of individuals in the United States as prediabetic by changing the criteria for the disease risk. At the same time, FDA approved 30 new diabetes drugs, allowing their introduction into the market with no rigorous proof that treatment with any of the new agents improved lives.
Since Virginia became the first state in May 2013 to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug, there has not been much activity or clarity on the issue.
The world’s leading 30 pharmaceutical companies spent a combined $112 billion on research and development (R&D) in 2013, an increase of $723 million over the previous year. According to our new Global Pharmaceutical Benchmark Report, Roche was the R&D spending leader, outlaying nearly $10 billion in 2013. Meanwhile, Novartis and Johnson & Johnson (J&J) increased their R&D spend the most between 2012 and 2013, with each adding around $500 million to their respective clinics. Novartis’ R&D spending grew by 5.6% to $9.8 billion, and J&J spent $8.2 billion, which was up by 6.8% from 2012.
FDA approved the Maestro Rechargeable System, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
The Centers for Disease Control’s new guidance that hospitalized and high-risk patients with unconfirmed but suspected flu should be administered anti-virals without waiting may cause additional medication shortages, according to a pharmacist and professor.
FDA has approved long-acting release (LAR) pasireotide (Signifor, Novartis) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
It’s no secret that the compounding industry is under greater scrutiny these days. A number of high-profile cases, including recent deaths linked to outsourced intravenous (IV) compounding at a Texas hospital, have moved patient safety concerns front and center.1 In the wake of ongoing fallout and a 2-year crackdown on compounding centers by FDA, many hospitals are analyzing their current strategy and rethinking the pros and cons of outsourced IV compounding.
FDA has approved gadobutrol (Gadavist, Bayer HealthCare) injection for use with magnetic resonance imaging (MRI) in pediatric patients aged younger than 2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. It is the first gadolinium-based contrast agent for patients aged younger than 2 years, including term neonates
Afatinib extends overall survival in lung cancer patients whose tumors have the most common epidermal growth factor receptor (EGFR) mutation compared with chemotherapy, according to study results published in The Lancet Oncology from 2 independent phase 3 clinical trials in EGFR mutation-positive patients with metastatic non-small cell lung cancer (NSCLC).
FDA has approved carbidopa-levodopa (Duopa, AbbVie) enteral suspension for the treatment of patients with advanced Parkinson’s disease.
Prostate cancer is the most frequently diagnosed cancer, aside from non-melanoma skin cancer, in men in the United States. According to the American Cancer Society, an estimated 233,000 new cases of prostate cancer and an estimated 29,480 deaths from prostate cancer will have occurred in the United States during 2014. About 60% of all prostate cancer cases are diagnosed in men aged 65 years and older, and 97% of cases occur in men aged 50 and older. The incidence of prostate cancer is 60% higher in African Americans than in whites.
In a drug safety communication, FDA said that it is aware of recent reports questioning the safety of prescription and over-the-counter (OTC) pain drugs when used during pregnancy, but that it lacks adequate studies to change current recommendations.
The factor Xa inhibitor edoxaban (Savaysa, Daiichi Sankyo) has been approved by FDA to lower the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).
FDA approved a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva, Genentech, a member of the Roche Group) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL).
FDA approved an extended-release oral capsule formulation of carbidopa-levodopa (Rytary, Impax Pharmaceuticals, a division of Impax Laboratories, Inc.) for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.
Novartis AG’s biosimilar cancer drug, EP2006, is “highly similar” to Amgen’s blockbuster cancer drug, Neupogen, FDA staff said in a new report.
