News

Roflumilast, a drug recently approved in the U.S. to treat severe chronic obstructive pulmonary disease (COPD), increases the production of a protein that causes inflammation – which possibly results in patients developing a tolerance to the drug after repeated use and renders it ineffective, according to a new study.

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.

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.

The overwhelming majority of state health insurance marketplace plans are not providing required coverage for smoking cessation, according to a new report from the American Lung Association.

There might be a reprieve if the Supreme Court overturns the ACA's tax subsidies offered on federally-facilitated exchanges.

FDA has approved a new administration option for ticagrelor (Brilinta, AstraZeneca) in acute coronary syndrome patients.

FDA has approved label update for abiraterone acetate (Zytiga, Janssen) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.

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.

UnitedHealth Group’s announcement that its free-standing pharmacy care services business, OptumRx, will merge with Catamaran Corp., the fourth largest pharmacy benefit manager in the U.S., makes sense, according to industry experts.

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.

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.

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.

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.

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.

The Food and Drug Administration (FDA) is approving new drugs – especially those to treat cancer – at a near record pace this year.

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.

The Affordable Care Act’s medical loss ratio provision yielded more than $5 billion in benefits to consumers from 2011 through 2013, either through the rebates that insurance companies have paid to them or through reduced health plan spending on overhead, according to a new Commonwealth Fund report.

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.

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.

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.

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.

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.

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.

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 has expanded the approval of aflibercept (Eylea, Regeneron) injection to treat diabetic retinopathy in patients with macular edema.

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.

Half of all consumers who received advance tax credit subsidies for health insurance in 2014 would have to pay back a portion of them to the Internal Revenue Service (IRS), according to a new analysis by the Kaiser Family Foundation.

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.