Drug Pipeline

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.

Merck is halting sales of its cholesterol drug-extended-release niacin/laropiprant (Tredaptive)-after preliminary data from a study showed that it did not achieve its primary end point of reduction of major vascular events and also raised safety concerns.

New findings could help physicians to selectively use acid-suppressive medications when needed, and avoid using them when there is no indication that patients are at risk

Patients with acute coronary artery syndrome and those undergoing percutaneous coronary intervention should be maintained on low-dose aspirin therapy, a recent study demonstrates.

The smoking cessation aid varenicline (Chantix, Pfizer) may increase the risk of cardiovascular events in adults with cardiovascular disease, according to a recent FDA safety announcement.

The American Academy of Pediatrics has announced its endorsement of the World Health Organization?s (WHO) recommendation that thimerosal not be banned from vaccines.

Canagliflozin (Janssen Research & Development), developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, raised the level of bad cholesterol in patients during clinical trials and may post heart risks, according to FDA and reported by Reuters.

In 2012, FDA was able to achieve milestone and make groundbreaking strides through the approval of 39 innovative and cutting-edge drug therapies to populations in need.

Women who regularly took the analgesics ibuprofen or acetaminophen 2 more days per week had an increased risk of hearing loss, according to a recent study published in a recent issue of the American Journal of Epidemiology.

Antimicrobial stewardship programs are being implemented in a variety of settings to assist with the challenges associated with the management of infectious diseases. Here's a review of ASPs from the perspective of a formulary decision-maker.

With limited treatments available, the discovery of mutations in Janus kinase 2 (JAK 2) in 2005 was a major step forward for scientists in search of new therapies for myeloproliferative neoplasms (MPNs).

The American Academy of Pediatrics has announced its endorsement of the World Health Organization's (WHO) recommendation that thimerosal not be banned from vaccines.

Benzodiazepines, which have been associated with an increased incidence of infections in the critically ill, also may increase the risk of community-acquired pneumonia, according to a recent report published in Thorax.

Adverse drug events in the elderly can be prevented with appropriate monitoring, according to CDC.

A study of 1.7 million patients with diabetes indicates that reducing inflammation of the mouth can produce improvement in other health measures.

A look at the statin prescription trends in the Advocate Physician Partners organization.

Perampanel is a selective, non-competitive AMPA receptor antagonist that is used as adjunctive therapy for refractory partial-onset seizures and was approved by the FDA on October 22, 2012.

Gastric bypass surgery can improve glycemic control in adults with type 2 diabetes, but doesn't cure diabetes, according to the largest community-based study of long-term diabetes outcomes after bariatric surgery, published online ahead of print in Obesity Surgery.

New molecular entity: FDA approved linaclotide (Linzess, Ironwood Pharmaceuticals and Forest Pharmaceuticals) for the treatment of chronic idiopathic constipation and irritable bowel syndrome (IBS) with constipation in adults.

Recent FDA action (through December 2012) related to, Rabeprazole sodium delayed-release sprinkle capsules, CXA-201, CB-215, Buprenorphine subdermal implant, LX1033, ISIS-TTR Rx, Digoxin Immune Fab, Glucagon, AAV1-FS344, Trans sodium crocetinate, Betamethasone valerate foam 0.12%

African-American men and women continue to have higher risks of dying at the first presentation of heart disease compared with their white counterparts, according to a study published in the Journal of the American Medical Association.

Self-management has small effects on pain and disability in people with low back pain, according to a study published online in Arthritis Care & Research.

Recent FDA Approvals (through December 2012) related to (Bedaquiline, Janssen, Oseltamivir, Genetech, Apixaban, Bristol-Myers Squibb, Lomitapide, Aegerion, Varicella zoster immune globulin preparation, Cangene, Teduglutide, NPS Pharmaceuticals, Pasireotide diaspartate, Novartis, Ponatinib, ARIAD Pharmaceuticals, Influenza virus vaccine, GlaxoSmithKline, Raxibacumab, Crofelemer, Salix, Cabozantinib, Exelixis)

There is evidence of risk with the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and to neonatal health and beyond, according to a study published in Human Reproduction.