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All News - Page 90
FDA: Final guidance on evaluation, labeling of abuse-deterrent opioids
April 1, 2015
FDA has issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.
HIV/AIDS drugs reclassified at Aetna, Coventry in Florida
April 1, 2015
Aetna and Coventry Health Care of Florida are reclassifying certain HIV/AIDS medications labeled as specialty drugs to either generic or non-preferred brand drugs, according to Florida Insurance Commissioner Kevin M. McCarty.
FDA approves new administration option for Brilinta
March 31, 2015
FDA has approved a new administration option for ticagrelor (Brilinta, AstraZeneca) in acute coronary syndrome patients.
FDA approves label update for Zytiga
March 31, 2015
FDA has approved label update for abiraterone acetate (Zytiga, Janssen) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.
BioCryst receives $12 million to develop Ebola drug
March 31, 2015
On March 31, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded approximately $12 million to BioCryst Pharmaceuticals of Durham, N.C., for the advanced development of a promising experimental drug for Ebola.
New hep C drugs will strain the system: MD Anderson study
March 30, 2015
The cost of treating people infected with the hepatitis C virus (HCV) with newly approved therapies is likely to place a tremendous economic burden on the country’s healthcare system, according to a study published in the March 17 issue of the Annals of Internal Medicine.
New insulin may get speedy FDA approval
March 30, 2015
Pharmaceutical manufacturer Novo Nordisk, based in Denmark, said it will re-submit its new insulin drug, Tresiba, to the Food and Drug Administration (FDA) for approval. The company could approval as early as this fall, which would signal a 2016 launch, according to Reuters.
Drugs boost virologic response for Hepatitis C patients with HIV
March 30, 2015
A combination of medications effectively produced a sustained virologic response (SVR) in Hepatitis C virus (HCV) patients also infected with HIV, according to two new studies.
Statins: Discontinue in terminal illnesses
March 30, 2015
Discontinuing statin use in patients with late-stage cancer and other terminal illnesses may help improve patients’ quality of life without causing other adverse health effects, according to a study published in JAMA Internal Medicine.
Save the spoon: Use metric-dosing devices for kids’ liquid meds
March 30, 2015
Don’t use a kitchen spoon to give children liquid medications; instead use metric milliliter-only dosing, urges a statement, published online March 30 in Pediatrics.
AAD 2015: Secukinumab improves skin clearance in plaque psoriasis patients over widely used therapy
March 27, 2015
Plaque psoriasis patients treated with secukinumab (Cosentyx) over ustekinumab (Stelara)-a widely used biologic-can achieve clearer skin, according to a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology (AAD), in San Francisco.
Faster FDA approvals lead to cancer drug boom
March 27, 2015
The Food and Drug Administration (FDA) is approving new drugs – especially those to treat cancer – at a near record pace this year.
FDA approves DTaP-IPV combo vaccine for children ages 4 to 6
March 27, 2015
FDA has approved use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV (Quadracel, Sanofi Pasteur, the vaccines division of Sanofi) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged 4 through 6 years.
Study: Medication effectiveness diminishes when patients crush tablets
March 26, 2015
People who take more than 4 doses of medicine a day appear more likely to crush tablets or open capsules potentially reducing their effectiveness, according to a study published in the Journal of Pharmacy Practice and Research.
New HHS plan on opioids ups naloxone use
March 26, 2015
Health and Human Services (HHS) recently launched a widespread initiative – including increasing the use of naloxone to reverse opioid overdoses – aimed at reducing prescription opioid and heroin related overdose, death and dependence.
Tanezumab clinical trials to resume
March 25, 2015
Pfizer and Eli Lilly and Company said they will resume Phase 3 clinical studies for tanezumab for chronic pain, after the Food and Drug Administration (FDA) lifted a partial hold on trials.
FDA warns about serious reactions to Harvoni, Sovaldi
March 25, 2015
Both the Food and Drug Administration (FDA) and Harvoni and Sovaldi maker Gilead are warning Hepatitis C patients about serious bradycardia when the drugs are combined with certain other medications.
Treatment for inhalational anthrax approved
March 25, 2015
FDA has approved Anthrax Immune Globulin Intravenous (Human) (Anthrasil, Emergent BioSolutions) also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.
Letter details pediatric antipsychotic medication problems
March 25, 2015
Restrictive Medicaid prior authorization policies are leading to substitution of potentially inappropriate, off-label psychotropic medication use and other problems in prescribing antipsychotic medications for children, according to a recent research letter.
Tiotropium improved asthma symptoms in phase 3 trials
March 25, 2015
New data from Phase III trials showed that the addition of tiotropium Respimat in adult patients with mild, moderate and severe asthma who continue to experience symptoms despite the use of maintenance therapies improved lung function. Boehringer Ingelheim recently presented the new data on investigational tiotropium delivered via Respimat® inhaler at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas.
FDA expanded approval of aflibercept injection to treat diabetic retinopathy
March 25, 2015
FDA has expanded the approval of aflibercept (Eylea, Regeneron) injection to treat diabetic retinopathy in patients with macular edema.
DME study: Aflibercept injection shows greater gains in visual acuity than alternative anti-VEGF therapies
March 24, 2015
In patients with moderate or worse vision loss at baseline, those treated with aflibercept (Eylea, Regeneron) Injection gained, on average, an additional full line or more on an eye chart when compared to those treated with alternative anti-VEGF therapies, according to a study published in the New England Journal of Medicine.
Drugs in Perspective: Opdivo (nivolumab)
March 23, 2015
On December 22, 2014, Opdivo (nivolumab) was approved by FDA with a breakthrough therapy designation. Nivolumab is the second human programmed death-1 (PD-1) receptor-blocking antibody to gain accelerated approval for treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
Hepatitis C therapies, compounded meds drive increase in US drug spending
March 23, 2015
New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1% increase in US drug spending in 2014 – a rate not seen in more than a decade, according to Express Scripts 2014 Drug Trend Report.
ACC: NVAF patients at high risk for stroke may be undertreated
March 23, 2015
Many nonvalvular atrial fibrillation (NVAF) patients at high risk for stroke may be undertreated, according to poster presentation sessions at the American College of Cardiology (ACC) 64th Annual Scientific Session in San Diego, Calif.
Study: 4F-PCC may be beneficial over plasma in patients needing warfarin reversal for urgent surgical, invasive procedures
March 20, 2015
Prothrombin Complex Concentrate [Human] (Kcentra) is non-inferior and superior to plasma for rapid international normalized ratio (INR) reversal and effective hemostasis in patients needing Vitamin K antagonist (VKA, eg, warfarin) reversal for urgent surgical or invasive procedures, according to a study published in The Lancet. INR is a standardized method of assessing the effects of VKA therapy commonly used by clinicians
Pharmacy stakeholders support controlled substances document
March 20, 2015
A coalition of stakeholder organizations – including the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) – released a consensus document on the "red flag" warning signs related to prescribing and dispensing controlled substance prescriptions.
FDA panels approve Breo Ellipta for asthma in adults, not kids
March 20, 2015
Food and Drug Administration (FDA) committees this week voted to approve GlaxoSmithKline and Theravance’s Breo ELlipta (fluticasone furoate/vilanterol) as an asthma treatment for adults 19 years and older, but not for 12 to 17-year-olds.
FDA warns consumers about OTC homeopathic asthma treatments
March 20, 2015
The FDA warns consumers not to rely on the use of over-the-counter homeopathic therapies for the treatment of asthma. Without appropriate management, asthma could lead to a life-threatening asthma attack. Homeopathic remedies have not be evaluated by the FDA and may interfere with asthma management.
[BLOG]: FDA approves first biosimilar in US, may lead to easier access to biologic medications for patients
March 19, 2015
In this guest blog post, Larry LaMotte, spokesperson for Patients for Biologics Safety & Access and Vice President of Public Policy at the Immune Deficiency Foundation, discusses the possibility of biosimilars helping increase access to vital medications for patients with chronic and life-threatening conditions.
