Drug Pipeline

Gonorrhea, caused by the bacterium, Neisseria gonorrhoeae, continues to be a major US public health problem in terms of its prevalence as well as the lack of effective treatments available.

A new Institute of Medicine (IOM) report addresses growing concerns in the global community surrounding the public safety matters of fake and substandard drugs.

A single corticosteroid injection to treat unilateral lateral epicondylalgia-tennis elbow-is linked to poorer outcomes after 1 year, according to a study published February 6 in JAMA.

The National Breast Cancer Coalition recently awarded a nearly $200,000 seed grant to two researchers who will study the viral connection to breast cancer. The research will assess the infectious agent in breast tumors compared to normal breast tissue, which could lead to a preventive vaccine.

Physicians who attended a medical school with an active gift restriction policy were subsequently less like to prescribe newly marketed psychotropic medications over older, cheaper alternatives, according to a study published in the January 2013 issue of BMJ.

Canagliflozin is a sodium glucose co-transporter inhibitor under review for FDA approval for the treatment of type 2 diabetes mellitus.

Patients who take a combination of diuretics and either angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and add NSAIDs, have an increased risk of acute kidney injury, according to a study online in BMJ.

Polypharmacy screening has the significant potential to improve medication safety.

FDA and the Federal Trade Commission (FTC) issued a warning letter to Flu and Cold Defense LLC (Boca Raton, Fla.) for making misleading, unproven claims about its GermBullet inhaler, and said the company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.

Recent FDA action (through January 2013) related to, IPX066, Afatinib, Enobosam, GTx-024, Elafin, Ezatiostat HCL, Tranexamic acid tablets, Lamotrigine extended-release tablets

New molecular entity: A benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients age 2 years or older.

Recent FDA Approvals (through January 2013) related to (Deferasirox, Exjade, Novartis, bevacizumab, Avastin, Roche Group, trivalent influenza vaccine, Flublok, Protein Sciences, Budesonide, Uceris, Santarus, pooled plasma blood product, Octaplas, Octapharma, Sumatriptan iontophoretic transdermal system, Zecuity, NuPathe, onabotulinumtoxinA, Botox, Allergan

A look at the evidence in support of supplemental vitamin use during pregnancy.

Diabetes mellitus is a chronic condition characterized by elevated blood glucose that occurs as a result of impaired insulin action or production. This article focuses on current recommendations for the treatment of type 2 diabetes and methods of controlling co-occurring conditions.

The specialty pharmaceutical market is currently fragmented with extreme variation in knowledge/education, patient care management, service, and outcomes.

Optum and Mayo Clinic have partnered to launch Optum Labs, an open facility designed to enable collaborative research and innovation focused on better patient care.

Treatment of advance kidney cancer has evolved considerably over the last decade, and multiple agents are available.

A stool substitute therapy has promise as an approach to eradication of refractive Clostridium difficile (C difficile) in a proof-of-principle study published January 9 in the inaugural issue of Microbiome.

Medical used of probiotics could be significant in minimizing Clostridium difficile (C difficile) infection among hospitalized patients taking antibiotics.

Making prescription refills more affordable and easier to get may reduce disparities among hypertension patients, according to a study.

The cost of managing diabetes patients is extremely high, and many patients still experience poor glycemic control and renal complications, according to results of a study.

FDA issued a draft guidance last month to help the industry in the development of opioid drug formulations with abuse-deterrent properties, saying it considers development of these products a high public health priority.

Patients with erectile dysfunction (ED) have a 44% increased risk of cardiovascular (CV) events, according to a study, published online in Circulation: Cardiovascular Quality and Outcomes.

FDA has expanded the approved use of deferasirox (Exjade, Novartis) to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).

The spike in flu cases over the past month, along with limited supplies of influenza vaccine and Tamiflu across the United States, has led FDA Commissioner Margaret Hamburg to issue guidance to pharmacists and other healthcare providers.

FDA expanded the approved use onabotulinumtoxinA (Botox, Allergan) to treat adults with overactive bladder (OAB) who cannot use or do not adequately respond to a class of medications known as anticholinergics

Researchers examining the effectiveness of cefixime in the treatment of gonorrhea found a relatively high treatment failure rate, raising concern that gonorrhea may become untreatable, according to results published January 9 in the Journal of the American Medical Association.

FDA’s recent approval of crofelemer (Fulyzaq, Salix Pharmaceuticals, under license from Napo Pharmaceuticals), 125 mg delayed-release tablets, the first anti-diarrheal drug for HIV/AIDS patients taking antiretroviral therapy (ART), is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience noninfectious diarrhea, which often can lead to reduced treatment compliance.

FDA approved the first trivalent influenza vaccine (Flublok, Protein Sciences) made using an insect virus (baculovirus) expression system and recombinant DNA technology for the prevention of seasonal influenza disease in people aged 18 to 49 years.

FDA approved a pooled plasma (human) blood product (Octaplas, Octapharma) for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels.