Data from 2 phase 3 studies of lesinurad in combination with allopurinol in gout patients was presented at the American College of Rheumatology (ACR) 2014 annual meeting in Boston.
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Myalept (metreleptin) is a leptin analogue with the same physiologic effects as leptin.11 Metreleptin was granted a priority review and was FDA approved on February 25, 2014, as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired lipodystrophy.
FDA announced that it will review results from a clinical trial showing that long-term dual antiplatelet therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.
Investigational drug LCZ696 (Novartis), an angiotensin receptor neprilysin inhibitor (ARNI), is superior to angiotensin-converting enzyme (ACE) inhibitor alone in reducing the risks of death and of hospitalization for heart failure, according to data presented at the American Heart Association's (AHA) Scientific Sessions in Chicago.
It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Treatment with the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) significantly improved overall survival (OS) compared to vemurafenib monotherapy in previously untreated patients with BRAF V600E/K mutation-positive metastatic melanoma, without increased overall toxicity, according to a study published in the New England Journal of Medicine.
FDA has approved alemtuzumab (Lemtrada, Genzyme, A Sanofi Company) for the treatment of patients with relapsing forms of multiple sclerosis (MS).
The new combination hepatitis C drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) has been found to be highly effective in treating patients with cirrhosis who have not benefited from previous therapies.
FDA has warned about 2 approved generic versions of Concerta tablets to treat attention-deficit hyperactivity disorder (ADHD).
Many people who report an allergy to penicillin actually are not allergic to penicillin, according to a study presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, in Atlanta.
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The shortage of saline solution among hospitals is ongoing and doesn’t appear to be resolving anytime soon, according to a quality executive with the American Society of Health-System Pharmacists (ASHP). In addition, safety concerns make it prohibitive for hospitals to compound their own solutions.
FDA has approved a first-of-its-kind, personalized blood test to predict the likelihood of organ rejection in children with liver or intestine transplants (Pleximmune). The test was developed by researchers at Children’s Hospital of Pittsburgh of UPMC to determine a personalized rejection-risk index with cell-based technology.
FDA has approved ramucirumab (Cyramza, Eli Lilly) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
A new study has found a greater bleeding risk associated with the use of dabigatran (Pradaxa, Boehringer Ingelheim) in patients with nonvalvular atrial fibrillation (AF) than that cited on initial FDA approval of the drug.
FDA has approved simeprevir (Olysio, Janssen) in combination with sofosbuvir (Sovaldi, Gilead) as an oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis infection in adults.
Rosuvastatin (Crestor, AstraZeneca), a cholesterol-lowering agent, is currently the most-prescribed drug among the 100 most-prescribed and best-selling drugs in the United States. In the past 12 months, new prescriptions and refills for rosuvastatin have been estimated to amount to 23.7 million.
The risk of moderate or severe exacerbations in patients with severe but stable chronic obstructive pulmonary disease (COPD) who receive tiotropium plus salmeterol has been found to be similar among subjects discontinuing inhaled glucocorticoids and subjects continuing their use. Nevertheless, in making decisions about maintenance therapy for these patients the effect of withdrawal of glucocorticoids on their symptoms and pulmonary function should be carefully considered.
Specialty drug spending per user has increased considerably in recent years, but still represents a small portion of overall drug spending per beneficiary, according to a study published recently in Health Affairs.
Otezla (apremilast), a small-molecule inhibitor of phosphodiesterase 4 (PDE4), was approved by FDA on March 21, 2014, for the treatment of adult patients with active psoriatic arthritis. On September 23, 2014, it was approved for a second indication, the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy
FDA has approved Flublok (Protein Sciences) recombinant influenza vaccine for all adults aged 18 years and older. Previously, Flublok was indicated for adults aged 18 to 49 years.
FDA drug approvals, fast-track designations
FDA has approved once-daily dapagliflozin and metformin hydrochloride extended-release (Xigduo, AstraZeneca) (XR) for the treatment of adults with type 2 diabetes. Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
In children discharged home with a fracture, both ibuprofen and oral morphine were effective at relieving pain. However, there were no significant differences in efficacy between the 2 agents and oral morphine was associated with more side effects, according to a study published in the Canadian Medical Association Journal.
FDA advisors have recommended approval of a 60-mg dose of edoxaban (Daiichi Sankyo), a once-daily anticoagulant that inhibits Factor Xa, for some atrial fibrillation patients, but suggested limiting its use to those with abnormal kidney function.
Meningococcal group B vaccine (Trumenba, Pfizer) has been granted accelerated approval by FDA as the first vaccine licensed in the United States for active immunization to prevent invasive meningococcal B disease from Neisseria meningitidis serogroup B.
FDA has approved sotalol hydrochloride oral solution (Sotylize, Arbor Pharamceuticals) for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter.
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