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All News - Page 89
Rivaroxaban versus warfarin for NVAF patients scheduled for catheter ablation: New insights
May 20, 2015
Nonvalvular atrial fibrillation (NVAF) patients taking uninterrupted rivaroxaban or warfarin had a low rate of major bleeding and thromboembolic complications, according to data presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, and published in the European Heart Journal.
Hep C patient sues Blue Cross for denying Harvoni coverage
May 19, 2015
A Hepatitis C patient is suing Blue Cross because the payer will not cover her Harvoni medication. According to the complaint, filed this week in Los Angeles Superior Court by Shernoff Bidart Echeverria Bentley LLP, Blue Cross has arbitrarily chosen to give the treatment only to those patients suffering from the worst stages of liver damage.
SGLT2 inhibitors for diabetes may cause ketoacidosis, FDA warns
May 19, 2015
The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
Hep C, cancer drugs make up bigger percentage of Rx costs
May 18, 2015
The population of Americans who spend more than $50,000 per year on prescription drugs grew 63% in 2014, largely driven by hepatitis C and cancer therapies, according to an Express Scripts report.
Economist: $37 billion needed to combat “superbugs”
May 15, 2015
Global pharmaceutical manufactures need to invest billions of dollars to prevent antibiotic-resistant “superbugs”, according to Jim O’Neill, an economist leading a UK government review into antimicrobial resistance.
Pediatric migraine drug gets FDA green light
May 15, 2015
FDA has approved sumatriptan and naproxen sodium (Treximet, Pernix Therapeutics) for the treatment of migraines in pediatric patients.
New antibacterial treatment for plague approved
May 14, 2015
FDA has approved moxifloxacin (Avelox) for the treatment of patients with plague. Avelox has been approved under the Animal Efficacy Rule, because it was not ethical to conduct human trials.
Emerging multidrug-resistant H58 typhoid strain highlights need for antibiotic stewardship
May 14, 2015
A large international study, published in Nature Genetics, found that the H58 “superbug” version, which is resistant to multiple types of antibiotics, is now a major global health threat affecting many countries, including Asia and Africa, where typhoid is endemic.
Hospitals not doing all they can to prevent C diff infections
May 13, 2015
Nearly half of American hospitals aren’t taking key steps to prevent Clostridium difficile infection-despite strong evidence that such steps work, according to a new study published online in Infection Control & Hospital Epidemiology.
States blame hep C cases for increased opioid abuse
May 11, 2015
Hepatitis C infections are soaring in 4 states because of high rates of opioid abuse, according to a new report from the Centers for Disease Control and Prevention (CDC).
New forum expands access to biosimilars
May 11, 2015
The non-profit Biosimilars Forum was launched in May 2015 to offer credible, sustained, and unbiased education about biosimilars. The founding members of the Biosimilars Forum represent the majority of companies with the most significant US biosimilars development portfolios.
Patients gain power over pain, plus 4 more FDA approvals
May 8, 2015
Patients who are recovering from surgery in the hospital now have the opportunity to control their analgesic dosing, plus 4 more new therapies approved by FDA.
Oral pain meds overtake injectable therapies as preferred treatment for multiple sclerosis
May 8, 2015
Oral therapies are revolutionizing the treatment paradigm of multiple sclerosis (MS), offering enhanced dosing and patient compliance, according to new analysis. Frost & Sullivan’s A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market found that recent therapeutic advancements aim at improving the tolerability of existing products, specifically for interferon beta and glatiramer acetate. Developing anti-inflammatory medications has also been a key area of focus.
[BLOG]: 741 drugs in antibiotics pipeline, few first-in-class
May 8, 2015
Antibiotic resistance has grown at an alarming rate over the last few decades. To prevent a post-antibiotic era in which common infections could become lethal, an estimated 20 novel families of antibiotics must be developed in the next 50 years. Political groups in both the U.S. and Europe are each working to promote new development, but there are concerns the results may not come in time.
Belatacept demonstrates positive survival benefit in long-term open-label follow-up
May 8, 2015
New data from a fairly sizable, open-label follow-up trial, presented at the 2015 American Transplant Congress (ATC) in Philadelphia, showed a statistically significant 43% relative risk reduction of death or transplant failure in patients receiving the belatacept (Nulojix) FDA-approved dosing regimen.
FDA moves forward with approval of generic Abilify from 4 different manufacturers despite Otsuka pushback
May 7, 2015
FDA’s approval of generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, from 4 different generic manufacturers, has industry insiders pondering the generic drug market.
IPF patients struggle with quality-of-life issues
May 7, 2015
Idiopathic Pulmonary Fibrosis (IPF) patients have many unmet healthcare needs and support solutions need to be implemented, according to a study published in the May, 2015 issue of the Journal of Advanced Nursing.
Naloxone dispensing, education for pharmacists available in new guide from CPNP
May 6, 2015
Naloxone is a lifesaving antidote for reversing opioid overdose symptoms and the pharmacist’s role has quickly expanded in managing this population. NALOXONE ACCESS: A Practical Guideline for Pharmacists is designed to educate pharmacists on naloxone use and administration with the goal of providing increased patient access to this life-saving medication for opioid overdose.
ACO model saves Medicare $384 million
May 5, 2015
An innovative payment model created as a pilot project by the Affordable Care Act generated more than $384 million in savings for Medicare in its first two years, according to an independent evaluation report conducted by the Department of Health and Human Services (HHS).
Oncology drug spending soars
May 5, 2015
Total global spending on oncology medicines – including therapeutic treatments and supportive care – reached the $100 billion threshold in 2014, while spending on oncology drugs in the U.S. increased 5.3 percent compounded annual growth rate (CAGR) in 2014 to reach $42.4 billion, according to a new report.
Community initiative aims to improve type 2 diabetes care in Hispanic adults
May 4, 2015
Janssen Pharmaceuticals has launched a multifaceted initiative designed to support healthcare professionals who treat the culturally-unique needs of Hispanic adults with type 2 diabetes.
FDA approves first spray-dried sealant to stop bleeding
May 4, 2015
The FDA approved Raplixa (fibrin sealant [human]), used to help control bleeding during surgery, on April 30.
Patient-controlled pain drug device approved by FDA
May 4, 2015
Patients who are recovering from surgery in the hospital now have the opportunity to control their analgesic dosing. Ionsys (fentanyl iontophoretic transdermal system) from The Medicines Company has just been approved by FDA for this use.
FDA approves cough, cold drug
May 4, 2015
FDA has approved codeine polistirex and chlorpheniramine polistirex (Tuzistra XR, Vernalis plc and Tris Pharma) extended-release oral suspension, CIII (DEA Schedule III).
FDA approves Breo Ellipta for treatment for asthma in adults
May 4, 2015
FDA has approved fluticasone furoate/ vilanterol (Breo Ellipta) for the treatment of asthma in adults. Breo Ellipta is a fixed-dose combination of fluticasone furoate, which is an inhaled corticosteroid (ICS), and vilanterol, which is a long-acting beta 2 agonist (LABA). The fluticasone reduces inflammation while the vilanterol acts to open the airways. Breo Ellipta is administered using the Ellipta dry powder inhaler and comes in two strengths, 100/25 mcg and 200/25 mcg.
Hydrocodone prescribed most to Medicare beneficiaries
May 4, 2015
Generic Vicodin (hydrocodone acetaminophen) was the most widely-prescribed drug to Medicare Part D beneficiaries in 2013, according to new data released by the Centers for Medicare & Medicaid Services last week.
PCORI approves trial to determine best aspirin dose to help heart disease patients
May 4, 2015
The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors this week approved a 3-year, $14 million clinical trial designed to determine the best dose of aspirin to use to prevent heart attacks and strokes in people with heart disease.
FDA warns supplement firms over unapproved ingredient
May 4, 2015
The FDA issued warning letters to 14 dietary supplement manufacturers because they are using an ingredient not approved for use.The ingredient in question is 4-Amino-2-Methylpentane Citrate, also known as 1,3-Dimethylbutylamine, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, or DMBA.
FDA issues biosimilar final guidance
May 1, 2015
FDA has issued 3 final biosimilar guidances for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
