Formulary Watch |

5 reasons antibiotic resistance is a health crisis

Overuse and misuse of antibiotics has led to a public health crisis-a crisis we must pay attention to now, according to a report that will be published in the August issue of Consumer Reports.

FDA approves generic Comtan tablets for Parkinson's

FDA has approved Aurobindo’s entacapone tablets USP, 200 mg, the generic equivalent to Novartis’ Comtan tablets 200 mg.

New study to evaluate lipid management in clinical practice

As lipid management in the United States under goes transition in response to new guideline recommendations and expanding lipid-lowering therapy options, the Duke Clinical Research Institute (DCRI) announced a new study to better understand contemporary lipid management as well as the beliefs and attitudes of patient and providers regarding cholesterol, cardiovascular risk assessment, and options for lipid treatments.

Top 5 reasons Harvoni and Sovaldi may be in trouble

While sales of Gilead Science’s popular hepatitis C drug, Harvoni, had been performing well for several months, the trend has reversed of late. Hepatitis C drug Sovaldi, also from Gilead, has also hit some bumps in the road – in both the U.S. and China.

FDA OKs antiplatelet for use during heart procedure

FDA has approved cangrelor (Kengreal, The Medicines Company) for reducing the risk of periprocedural thrombotic events in patients undergoing percutaneous coronary intervention.

Top 5 ways bacteria are becoming resistant to antibiotics

Antibiotic resistance is a growing problem, both in the United States and across the world. The main driving factors behind antibiotic resistance are the overuse and misuse of antibiotics, according to the Centers for Disease Control and Prevention.

5 drug categories having the biggest impact on pharma spending

Here are 5 drug categories that may command the most impact on pharma spending in the near future.

4 ways the FAST Generics Act will help healthcare

Rep. Steve Stivers (R-Ohio) and Rep. Peter Welch (D-Vt.) have re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to what they say will increase consumer access to generic drugs, boost market competition and ultimately save consumers money.

"Smart" patch may eliminate need for insulin shots in diabetics

A new, painless “smart insulin patch” lowered blood glucose in a mouse model of type 1 diabetes for up to 9 hours, according to a study published in the Proceedings of the National Academy of Sciences.

Adults surpass kids for ADHD scripts

More adults than children in the United States now take medication for attention deficit hyperactivity disorder (ADHD), according to new data.

6 ways to avoid fluorouracil medication errors: ISMP

The Institute for Safe Medication Practices (ISMP) is cautioning hospital pharmacists and other healthcare professionals about the intravenous cancer medication fluorouracil.

5 drugs headed for $1B or more in sales by 2020

Global prescription drug sales should reach nearly $1 trillion by 2020, thanks in part to FDA approvals of breakthrough drugs for cancer, hepatitis C and other diseases, a new report finds.

FDA, PatientsLikeMe partner on drug safety data

The Food and Drug Administration (FDA) and PatientsLikeMe will work together to determine how patient-reported data can give new insights into drug safety.

Acid-reducing meds up risk of C diff infection in kids: Study

Infants and children who are given prescription acid-reducing medications face a substantially higher risk of developing Clostridium difficile infection, according to a study published recently in the online edition of Clinical Infectious Diseases.

Synergy Pharmaceutical's constipation drug garners positive results

Synergy Pharmaceuticals’ drug for chronic idiopathic constipation (CIC) has garnered very positive results in a phase 3 clinical trial, the company reported this week.

GLP-1 receptor more beneficial in reducing blood sugar compared to injectable therapy in Japanese patients

Once-weekly dulaglutide is an effective treatment option for patients with type 2 diabetes who need to advance to injectable therapy, according to results from a Japanese study presented at the 2015 American Diabetes Association Scientific Sessions in Boston

PCSK-9 inhibitors achieve next milestone, plus 4 more FDA actions

A summary of five FDA actions taken within the last few weeks.

FDA panel backs approval of GSK's mepolizumab for severe asthma

The FDA’s Pulmonary-Allergy Drugs Advisory Committee recently recommended approval of GlaxoSmithKline Plc's drug mepolizumab (Nucala) for severe asthma patients 18 and older.

FDA follow-up confirms low risk of long-term vision loss secondary to ezogabine pigment changes

FDA has issued a drug safety communication on GlaxoSmithKline's anti-seizure drug ezogabine (Potiga). Side effects of the the drug, which may include vision loss due to eye pigment change and skip discoloration, can be "adequately managed" by following the label, reports the FDA.

Promacta stimulates platelet production in cITP pediatric patients

FDA has approved eltrombopag (Promacta, Novartis) for the treatment of children aged 6 years and older with chronic immune thrombocytopenia.

Pharma needs to be more upfront about FDA drug rejections

FDA researchers are calling for greater transparency from drug companies when their drug is rejected by the agency, according to a study in the British Medical Journal.

The 4 most problematic drug shortages

Drug shortages are significant public health threats. They can delay, or even deny, critical care for patients. Here are the four drugs in shortage that are among the most problematic.

Actemra gets breakthrough therapy designation for scleroderma

The FDA has granted breakthrough therapy designation to tocilizumab (Actemra, Genentech) for the treatment of systemic sclerosis, a rare and potentially life-threatening disease with no FDA-approved therapy.

Florida passes naloxone law

This week, Florida Governor Rick Scott signed the Emergency Treatment for Opioid Overdose Act into law, allowing first responders to possess, store, and administer naloxone.

Ibrutinib interim data promising in patients with chronic graft-versus-host-disease

Ibrutinib may be a safe and potentially effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were refractory to steroid treatment or steroid-dependent, suggested interim data presented at the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Patient groups bothered over diminished safety standards for biosimilars

Patients for Biologics Safety & Access (PBSA) sent a letter to FDA addressing safety concerns about final FDA guidance documents issued for biosimilars.

Sleep study: Suvorexant effective in people with insomnia

Suvorexant (BELSOMRA) was an effective and well-tolerated treatment of insomnia, according to a new study presented at SLEEP 2015 in Seattle, Washington.

Heartburn drugs linked to heart attacks

Certain Protein-pump inhibitors (PPIs) such as omeprazole (Prilosec) are associated with a short-term risk of heart attacks and other cardiac events, according to a new study.

FDA's Sentinel Initiative identifies drug safety problems

The FDA's Sentinel Initiative uses big data and broad networks to detect and respond to risks associated with prescription drugs. In the June 4th Health Affairs' Health Policy Brief, the FDA describes how the Sentinel Initiative improves on the FDA's Adverse Event Reporting System (FAERS) database.

FDA panel recommends approving Repatha, Praluent to lower cholesterol

FDA’ s Endocrinologic and Metabolic Drugs Advisory Committee recommended this week to approve cholesterol-lowering drug evolocumab (Repatha) from Amgen in a 15-0 vote. It also voted 13-3 in favor of FDA approving Sanofi and Regeneron's Praluent (alirocumab), but most panel members called for a restricted label in high-risk patients with genetic conditions causing elevated cholesterol, rather than wider use in the general elevated cholesterol population.