Drug Pipeline

Election-year politics will color a range of legislative and policy developments affecting drug development, production, and reimbursement in the coming year, as efforts to reduce government spending on healthcare prompts all parties to search for opportunities to do more with less. Looming over the political landscape is the upcoming Supreme Court decision on the constitutionality of the Obama health reform legislation.

New molecular entities (NMEs) for calendar year 2011 number 30, considerably above the average of 23 during the past 10 years. Notably among this list are 8 drugs for cancer; 10 targeting orphan diseases; 2 each for hepatitis C and chronic obstructive pulmonary disease (COPD); and 3 anticoagulants.

The oral anticoagulant rivaroxaban lowered the risk of death, heart attack, and stroke in acute coronary syndrome (ACS) patients, according to a study presented at the American Heart Association's Scientific Sessions 2011 in Orlando, Fla., in mid-November.

Even though a new study did not show a correlation between pharmacist intervention and hospitalization and death rates for heart failure patients, the Heart Failure and Optimal Outcomes from Pharmacy Study (HOOPS) is an important study.

Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride

Spending growth for specialty drugs rose 19.6% between 2009 and 2010, while growth of traditional drugs decreased by 1.4%, according to Express Scripts' 2010 Drug Specialty Report. Payers are struggling to appropriately manage high-cost drugs while ensuring their members get the care they need. One strategy is introducing a specialty drug tier to the formulary, which raises a red flag on access issues.

The 12th Asian Conference on Clinical Pharmacy will be held July 7-9, 2012, at the Hong Kong Convention and Exhibition Centre.

FDA’s Vaccines and Related Biologics Advisory Committee recently voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) for the prevention of pneumococcal disease in adults age 50 years and older, Pfizer Inc, the drug’s manufacturer, said in a statement.

FDA has changed the label for fenofibric acid (Trilipix, Abbott). It now carries a warning that the agent may not lower the risk of myocardial infarction or stroke.

All children and adolescents should be screened for high cholesterol, and children as young as aged 10 should be considered for treatment with statins, according to the latest update from an expert panel convened by the National Heart, Lung, and Blood Institute.

The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease.

Some essential chemotherapy drugs are in short supply for the first time in the United States, according to the October 3 New England Journal of Medicine.

FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance, the agency said on November 3 in an ongoing safety review of this class of biologic products.

New formulation: Tapentadol extended release tablets were FDA approved for the management of moderate-to-severe chronic persistence pain requiring continuous maintenance in adults.

This study aims to illuminate anticoagulation prophylaxis practice patterns in the United States after total joint replacement surgery.

Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.

The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medicines to treat cancer, pain, and other serious conditions is drawing attention from the White House, Congress and the broader healthcare system.

Switching hospitalized patients able to take medication by mouth from intravenous to pill forms of the same drugs could safely save millions of dollars a year.

Pharmacogenomics can change the way patients are treated.

Patients with hepatitis C virus (HCV) who were more adherence to their pegylated interferon and ribavirin treatment were more likely to achieve both an early and sustained virologic response.

When an anthracycline is not used concomitantly with adjuvant trastuzumab to treat HER2-positive breast cancer, cardiac toxicity is reduced.

Specialty pharmaceutical research and development spending is expected to increase with the focus on "biobetters", biosimilars, and novel therapies.

The rheumatoid arthritis payer market has experienced increasingly competitive forces, prompting RA drug manufacturers to experiment with new contracting initiatives to gain preferred formulary placement.

Recent FDA Approvals (through October 2011) related to Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox

New molecular entity: Ezogabine was FDA approved for use as an add-on medication to treat partial-onset seizures associated with epilepsy in adults.

Edith Rosato, RPh, has recently been appointed new CEO of the Academy of Managed Care Pharmacy.

Recent FDA action (through October 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001,cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127

Crizotinib is a new kinase inhibitor recently approved by FDA for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who express the anaplastic lymphoma kinase gene.

Among the long-awaited provisions in PPACA are the additions to the Public Health Service Act that allow for the introduction of biosimilar medications to the marketplace.

Two Drug Safety Communications providing updated warnings regarding potentially serious interactions when methylene blue or linezolid are co-administered with certain serotonergic psychiatric medications were released by FDA on October 20, 2011.