Formulary Watch |
All News - Page 135
Elelyso (Taliglucerase alfa): A long-term enzyme replacement therapy for adults with type 1 Gaucher disease
August 1, 2012
New molecular entity: FDA approved taliglucerase alfa (Elelyso, Pfizer), a recombinant active form of the glucocerebrosidase enzyme for long-term enzyme replacement therapy (ERT) for adults with type 1 Gaucher disease.
Pertyze (Pancrelipase delayed-release capsules): A combination of porcine-derived lipases, proteases, and amylases for the treatment of exocrine pancreatic insufficiency (EPI)
August 1, 2012
New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
Delayed diagnosis, noncompliance, lack of communication, linked to hindering HIV care, IOM reports
August 1, 2012
The Institute of Medicine reports that a number of issues are causing a number of barriers to successful HIV care in the United States.
New oral anticoagulants for stroke prevention in atrial fibrillation: An update for managed care and hospital decision-makers
August 1, 2012
Atrial fibrillation(AF) is the most common sustained cardiac arrhythmia and a potent risk factor for stroke. Here's a review of new oral anticoagulants for stroke prevention with AF.
Carflizomib: A second-generation proteasome inhibitor for the treatment of myeloma
August 1, 2012
The introduction of the immunomodulatory drugs and bortezomib, a proteasome inhibitor, has dramatically improved outcomes in patients with relapsed or refractory multiple myeloma.
HCV screening projected to save 120,000 boomers' lives
August 1, 2012
Screening for hepatitis-C may soon become a routine screening for Baby Boomers.
Cetuximab as an add-on to leucovorin, fluorouracil, and oxaliplatin for stage 3 colon cancer adds no benefit
August 1, 2012
A new study seems to indicate that adding cetuximab to the standard therapy for resected stage 3 colon cancer provides no additional benefits.
Pipeline Preview
August 1, 2012
Recent FDA action (through July 2012) related to, morphine and oxycodone Dual Opioid platform, MoxDuo, QRxPharma, apixaban, Eliquis, Bristol-Myers Squibb, RG1068, Repligen, Multi-Stem, Athersys, Rivaroxaban, Xarelto, Janssen, Ocriplasmin intravitreal injection, ThromboGenics, Regorafenib, Bayer, Onyx Pharmaceuticals, Pregabalin, Lyrica, Lupin, Diclofenac sodium and misoprostol, Arthrotec, Watson, Next Choice One Dose, Plan B One-Step
FDA warns of seizure risk for multiple sclerosis patients who take dalfampridine
August 1, 2012
The FDA recently announced a safety communication regarding the risk of seizures with MS who are starting dalfampridine.
Few Americans attain CV health goals associated with decreased mortality
August 1, 2012
A recent study from JAMA indicates that most Americans aren't meeting the necessary goals to lower CV risks.
FDA Actions in Brief July 2012
August 1, 2012
Recent FDA Approvals (through July 2012) related to (Vivus, Gilead Sciences, Orasure, Pfizer, Ferring Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Qiagen, Astellas Pharma US, Roche Molecular Systems, Arena Pharmaceuticals, Eisai)
72nd American Diabetes Association Scientific Sessions: Clinical updates review findings on risk of malignancy with pioglitazone, as well as various risk factors associated with insulin glargine use
August 1, 2012
A review of drug therapies and research presented at the 2012 Scientific Session of the American Diabetes Association.
Prednisone delayed-release tablets approved for rheumatology indications
July 27, 2012
FDA has approved prednisone (Rayos, Horizon Pharma) delayed-release tablets (1 mg, 2 mg, and 5 mg) to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.
FDA panel unanimously recommends ranibizumab injection for DME
July 27, 2012
In a unanimous vote (10-0), an FDA advisory committee recommended approval of the 0.3-mg dose of ranibizumab injection (Lucentis, Genentech, a member of the Roche Group) for treatment of diabetic macular edema.
FDA targets unapproved oxycodone products
July 27, 2012
FDA is ridding the market of single-ingredient oxycodone capsules and oral liquids that are being distributed without an FDA-approved application.
Caffeine consumption may reduce BCC risk
July 27, 2012
A recent study in Cancer Research suggests that modest caffeine consumption may be associated with a significantly lower relative risk of basal cell carcinoma.
CDC updates recommendations for HBV management
July 27, 2012
The Centers for Disease Control and Prevention recently updated its 1991 recommendations for the management of hepatitis B virus (HBV)-infected healthcare providers and students to prevent HBV transmission to patients.
Fertility drug use and breast cancer risk
July 27, 2012
The Two Sister Study, funded in part by Susan Komen for the Cure, was conducted to examine the possible risks associated with fertility drugs and breast cancer. The results were published July 6 in the Journal of The National Cancer Institute.
CER studies will shape coverage decisions
July 25, 2012
To reduce the money spent on treatments that don't work, health plans and payers are examining closely how Comparative Effectiveness Research (CER) can steer patients and providers to more appropriate care. This approach is gaining momentum from the Patient Centered Outcomes Research Institute (PCORI), which is poised to distribute some $120 million in coming months—and nearly $400 million in 2013—to launch a range of CER projects.
FDA approves aclidinium bromide inhalation powder to treat COPD
July 24, 2012
FDA has approved aclidinium bromide inhalation powder (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
FDA approves carfilzomib for some patients with multiple myeloma
July 20, 2012
FDA has approved carfilzomib (Kyprolis, Onyx Pharmaceuticals) to treat patients with multiple myeloma who have received at least 2 prior therapies, including treatment with bortezomib (Velcade, Takeda) and an immunomodulatory therapy.
High-dose vitamin D recommended for elderly
July 20, 2012
The results of a recent literature review suggest that only a high intake of vitamin D leads to a significant reduction in the risk of fracture.
FDA approves once-daily phentermine and topiramate extended-release for weight management
July 20, 2012
FDA has approved once-daily phentermine and topiramate extended-release (Qsymia, Vivus) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 or greater, or 27 or greater in the presence of at least 1 weight-related comorbidity.
FDA approves first at-home HIV test
July 20, 2012
FDA recently approved the first over-the-counter test for HIV, providing a confidential in-home testing option for the virus that causes AIDS, with results in as little as 20 minutes.
FDA: Label change for single IV dose of ondansetron
July 20, 2012
FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.
FDA approves once-daily oral agent for HIV prevention in uninfected adults
July 17, 2012
FDA has approved once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
FDA approves generic Arthrotec
July 16, 2012
FDA has approved Watson's generic diclofenac sodium and misoprostol delayed-release tablets (Arthrotec, G.D. Searle, a subsidiary of Pfizer), indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
FDA: Reduce cefepime dose in patients with renal impairment
July 13, 2012
FDA issued a statement reminding healthcare professionals about the need to adjust the dosage of the antibacterial drug cefepime (Maxipime, Elan) in patients with renal impairment.
Fixed-dose ARB combo superior treatment for hypertension
July 13, 2012
A fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg (Edarbyclor, Takeda Pharmaceuticals) was statistically superior to a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg for the treatment of stage 2 systolic hypertension, according to a study published online in the American Heart Association journal Hypertension.
