News

On April 1, the Indian Supreme Court denied Novartis’ appeal challenging the rejection of a patent for its cancer drug Glivec (imatinib mesylate), which has been patented in almost 40 countries including China, Russia, and Taiwan. This landmark ruling ends a 7-year legal battle by Novartis, which never has been granted an original patent for Glivec in India. The ruling will hinder medical progress and innovation, the manufacturer said.

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) for adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.

In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by FDA, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to a review article in the March 27 issue of JAMA.

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) tablets to be used with diet and exercise, to improve glycemic control infor adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.

COPAY CARDS and discount programs are an increasingly important part of many pharmaceutical brands’ marketing strategy. Yet as copay offset programs have grown more popular, they have become increasingly controversial, as indicated by lawsuits, regulatory changes and backlash from pharmacy benefit managers and health plans.

In patients with heart failure with preserved ejection fraction, long-term treatment with spironolactone improved left ventricular diastolic function, but didn’t affect maximal exercise capacity, patient symptoms, or quality of life (QoL), according to a recent study in JAMA.

Humana and Boehringer Ingelheim Pharmaceuticals have announced a multi-year collaboration to address key questions regarding treatment and healthcare costs for patients with chronic obstructive pulmonary disease (COPD), cardiovascular disease, and other disease states.

Diabetes drug canagliflozin (Invokana, Janssen Pharmaceuticals) is the first drug approved by the FDA in a new class known as sodium-glucose co-transporter 2 (SGLT2) inhibitors to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research.

Young adults who have had a stroke are at higher risk of long-term mortality compared with expected mortality, according to report published March 20 in the Journal of the American Medical Association.

Nesina: a new dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes as an adjunct to diet and exercise. Oseni: a fixed-dose combination of alogliptin and pioglitazone. Kazano: a fixed-dose combination of alogliptin and metformin HCl

Recent advances in the treatment of metastatic castration-resistant prostate cancer CRPC) have led to new agents demonstrating overall survival (OS) advantages, including autologous cellular immunotherapy (sipuleucel-T), a new taxane (cabazitaxel), 2 therapies further targeting the androgen axis (abiraterone acetate and enzalutamide), and a bone-seeking alpha emitter (radium-223 chloride). This brief review discusses recent clinical trials utilizing the 2 FDA-approved taxanes that were presented at the 2013 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncologists (ASCO), American Society for Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO).

Although patients with rheumatoid arthritis (RA) have a disproportionately higher incidence of herpes zoster, an analysis that included nearly 60,000 patients with RA and other inflammatory diseases found that those who initiated anti-tumor necrosis factor (TNF) therapies were not at higher risk of herpes zoster compared with patients who initiated nonbiologic treatment regimens, according to a study appearing in the March 6 issue of JAMA.

Obesity has become a highly prevalent chronic condition that is associated with significant morbidity and mortality. Studies have demonstrated that even as little as 5% to 10% of weight loss is associated with an improvement in cardiovascular risk factors and a reduction in the incidence of type 2 diabetes in high-risk patients. Prior to the recent approval of lorcaserin and extended-release phentermine/topiramate, there had been no new pharmacologic agents approved for the treatment of obesity for 13 years. This article reviews the pharmacologic treatment of obesity including past treatment options, lessons learned in recent years, current short- and long-term treatment options, and future direction. Formulary considerations of currently available agents are discussed.

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released new regulations about the reporting of fees, meals, travel expenses, and other transfers of value for the implementation of the Physician Payment Sunshine Act (PPSA). These new regulations require that data on the payments and gifts that drug and medical device companies make to physicians will become available publicly in a searchable database beginning in September 2014.1

Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.

Diabetes drugs including exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto) are being evaluated by FDA for a potential link to pancreatitis and precancerous changes of the pancreas.

Long-term treatment with fixed-combination budesonide/formoterol (Symbicort Turbuhaler, AstraZeneca) was associated with fewer healthcare utilization-defined exacerbations and hospitalizations than fluticasone/salmeterol in patients with moderate and severe chronic obstructive pulmonary disease (COPD), according to a study published online in the Journal of Internal Medicine.

Tivozanib and sorafenib extended survival in advanced renal cell carcinoma (RCC) patients with no statistical difference, according to the phase 3 TIVO-1 (TIvozanib Versus sOrafenib in 1st Line Advanced RCC) trial data, presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), in Orlando, Fla., in February.

Drugs can be managed through the medical benefit or the pharmacy benefit

Experts expect all 50 states to be up and running on time

Infrastructure needed to ensure organizations live up to the promise of ACOs

New care models and federal requirements motivate HIE stakeholders

Big data can lead to improved outcomes

FDA committees are examining DTC genetic tests that make medical claims

When there's no rhyme or reason, prices spiral out of control

States contract with plans to cover expanded populations, many of which need high-cost care

Medicines that better control glucose and more efficient dosing needed

Medicare Advantage plans must comply with CMS regulations