New molecular entity: Gabapentin enacarbil extended-release tablets was approved by FDA as treatment for moderate-to-severe restless legs syndrome in adults.
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Multiple sclerosis is the most common disabling neurologic disease afflicting young adults in the United States. Since the majority of MS patients have normal or near-normal life expectancy, the clinical and economic burden is substantial, with disability typically worsening over time. Disease-modifying therapies have been shown to decrease and postpone long-term disability by lowering the relapse rate, extending the remission phase, and reducing the accumulation of new magnetic resonance imaging lesions and related neurologic deficits.
Within the next 5 years, approximately $100 billion will be lost on previous blockbuster brands that will lose patent protection.
Recent FDA action (through May 2011) related to Augment Bone Graft, crizotinib, DP-b99 development program, regorafenib, MCD-386CR, liver cell infusion of donated human liver cells
New biologic: Belimumab intravenous injection is a B-lymphocyte stimulator-specific inhibitor approved by FDA to treat systemic lupus erythematosus.
Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension
Recent FDA Approvals (through May 2011) related to Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev
Within the next 5 years approximately $100 billion will be lost on previous blockbuster brands that will lose (or lost) patent protection. For manufacturers to enhance their return on investment, they are refocusing on researching and marketing specialty drugs, according to a specialty pharmaceuticals pipeline update at the Academy of Managed Care Pharmacy?s 23rd Annual Meeting and Showcase, Minneapolis.
FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.
FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea.
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A look at the therapeutic pipeline for glaucoma shows several medications representing new pharmacologic classes are currently being evaluated in clinical trials, said John R. Samples, MD, at ASCRS Glaucoma Day 2011, San Diego.
A newly developed assay can measure the ability of antibiotics to associate with mammalian cells and protect the cells from bacterial destruction. Of 4 antibiotics tested in this assay, the data showed a range of therapeutic effectiveness in 2 cell lines that clinicians can consider when establishing dosing regimens, according to Jeremy Wingard, MD, who reported his group's findings at the American Society of Cataract and Refractive Surgery annual meeting, San Diego.
Pirfenidone, an investigational drug (InterMune) that inhibits the synthesis of TGF-beta and TNF-alpha, was associated with positive effects on lung function, 6-minute walk test distance, and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis, according to a study published in The Lancet.
At a fixed dose of 12 mg, methylnaltrexone bromide (Relistor, Progenics Pharmaceuticals) subcutaneous injection proved generally safe and well tolerated in non-malignant pain patients with opioid-induced constipation, according to a recent study.
First-trimester exposure to antiepileptic drugs compared with no exposure does not appear to increase the risk of major birth defects, according to a Danish study, published in the May 18 issue of the Journal of the American Medical Association.
Medication use among pregnant women is widespread and increasing, according to a recent study from the Boston University School of Public Health in Boston.
FDA has approved sunitinib malate (Sutent, Pfizer) as the first anti-vascular endothelial growth factor therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.
Vardenafil HCI (Staxyn, GlaxoSmithKline, Merck, and Bayer), an orally disintegrating tablet indicated for the treatment of erectile dysfunction in men, is now available in U.S. pharmacies.
NEW YORK (Reuters Health) - For patients with type 2 diabetes not controlled with metformin and a sulfonylurea, the choice of an additional agent should be based on individual clinical characteristics since improvements in glucose control are similar.
FDA approved telaprevir (Incivek, Vertex) tablets to treat certain adults with chronic hepatitis C infection.
FDA has approved rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy.
Proton pump inhibitors are associated with a 29% increased risk of fracture, including a 31% increased risk of hip fracture and a 54% increased risk of vertebral fracture, according to a study published in the May/June 2011 issue of Annals of Family Medicine.
More than half of Medicare claims for atypical antipsychotic drugs are erroneous, amounting to $116 million, according to a 48-page report released May 4 by the Office of the Inspector General.
Pediatric patients with moderately to severely active ulcerative colitis demonstrated a clinical response with infliximab (Remicade, Centocor Ortho Biotech), according to data from a phase 3 randomized, multicenter, open-label study.
There is no safe therapeutic window of time for using NSAIDs in patients with prior myocardial infarction. Even short-term treatment with most NSAIDs appears associated with increased risk of death and recurrent MI. In general, NSAIDs should be limited from a cardiovascular safety point of view, according to a study published in Circulation.
FDA has approved boceprevir (Victrelis, Merck) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients aged 18 years and older with compensated liver disease.
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