CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.
CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.
FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of ADHD in adolescents aged 13 to 17 years.
FDA has approved saxagliptin and metformin XR (Kombiglyze XR, AstraZeneca and Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus DPP-4 inhibitor combination tablet offering strong glycaemic control across glycosylated hemoglobin levels, fasting plasma glucose and post-prandial glucose.
FDA is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.
The Obama administration has decided to extend bonus payments meant to reward top-quality Medicare Advantage plans to those performing at average quality levels, and provide larger bonuses to top performers.
The need for better communication is apparently fueled by consumer uncertainty about federal healthcare reform. According to the survey, 44% say they are not sure how their health plan is impacted.
Findlay, Ohio is one of the first communities in the United States to establish a partnership between area businesses, physicians and the local hospital to initiate healthcare reform at the community level. The program, called the Employer Data Project (EDOC), is overseen by Blanchard Valley Health System (BVHS). Its goal is to reduce variation in care and improve treatment processes while lowering health care costs.
The Disease Management Purchasing Consortium (DMPC) and Zenger Analytics have completed a mathematical proof to address the question of valid outcomes methodologies for disease management, wellness, medical home and other population-based care management programs for which outcomes are calculated on a pre/post basis.
As healthcare costs continue to significantly outpace the rate of inflation and increases in compensation, an affordability gap is placing increasing pressure on employees and eroding satisfaction with their health plans.
An FDA panel has recommended that the agency approve Orexigen Therapeutics' and Takeda's obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.
Nonanthracycline-containing chemotherapy regimens for the adjuvant treatment of operable stage I to III breast cancer are discussed, including efficacy and toxicity results from recent randomized clinical trials comparing anthracycline to nonanthracycline-containing regimens.
FDA voted today against approving 2 drugs for the prevention of prostate cancer: finasteride (Proscar, Merck) and dutasteride (Avodart, GlaxoSmithKline).
Agents in late-stage development for the treatment of eye diseases.
The commonly used pain reliever-acetaminophen-causes a significant increase in blood pressure in patients with pre-existing coronary artery disease, according to a randomized controlled trial published ahead of print in the October 18, 2010, Circulation.
Removal of marketed unapproved drugs (MUDs), such as that with oral colchicine, is part of FDA's Unapproved Drugs Initiative (launched in 2006).
Throughout 2010, Formulary's "Focus on" articles have examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics (P&T) committee members. Because many readers have said that they frequently refer to this column when making formulary decisions for hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each.
Patients with systolic heart failure and mild symptomatology [New York Heart Association class II] taking the mineralocorticoid receptor antagonist-eplerenone-experienced a 37% reduction in death from cardiovascular causes or first hospitalization for heart failure, researchers demonstrated in a new study.
The new House leaders are gearing up for a vote to repeal health reform early next year. Such a move, though, is expected to be largely symbolic, as it's unlikely to pass the Senate or to override Obama's veto pen.
New molecular entity: Fingolimod (Gilenya) has recently been approved by FDA to treat patients with relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Generic drugs approved by FDA (through November 2010): Zafirlukast tablets and Desloratadine tablets
Specialty pharmaceuticals are expected to eventually replace non-specialty agents for the management of various conditions, including gout, lupus, diabetes, and hypercholesterolemia.
Azilsartan medoxomil (TAK-491), the prodrug form of azilsartan (TAK-536), is an ARB under review for FDA approval for the treatment of hypertension.
Rivaroxaban, an oral direct Factor Xa inhibitor given once daily was superior to warfarin in reducing the risk of stroke and non-central nervous system systemic embolism in patients with AF, with comparable rates of bleeding in the pre-specified on-treatment population, according to results from the ROCKET AF study.
About half of the top non-specialty drugs will become generic within the next 5 years, therefore the trend is for pharmaceutical companies to search and "co-develop" agents rather than investing large amounts of dollars in "R&D."
New molecular entity: Dabigatran etexilate (Pradaxa) was approved for stroke prevention in atrial fibrillation.
The outcomes associated with treating patients with chronic myelogenous leukemia improved dramatically when FDA approved imatinab. Subsequently, newer agents in the same therapeutic class have been approved, and early clinical studies suggest that they may become the new standard of care.
Recent FDA action (through, November 2010) related to Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502.
Recent FDA Approvals (through November 2010) related to Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron
FDA, in conjunction with Takeda Pharmaceuticals and researchers from the University of Pennsylvania and Kaiser Permanente Northern California, reported 5-year interim results of an ongoing, 10-year epidemiological study designed to evaluate whether pioglitazone (Actos) is associated with an increased risk of bladder cancer.