June 28th 2022
Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.
June 7th 2022
December 31st 2012
December 31st 2012
Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate
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Denosumab (Xgeva, Amgen) significantly increased bone metastasis-free survival for more than 4 months in men with castrate-resistant metastatic prostate cancer that had not yet spread to bone, according to results of a landmark study of Xgeva, presented at a late-breaking plenary session at the American Urological Association?s 2011 annual meeting in Washington, DC.
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Built to scale: Ed Sellers leads BlueCross BlueShield of SouthCarolina
May 1st 2006Every time a new stop light goes up in a growing neighborhood,BlueCross BlueShield of South Carolina (BlueCross) wants to have acustomer within a block of it. This health plan, nested withsubsidiary businesses, has prioritized growth through an aggressivebranching out from its core competencies. Half of its totalbusiness comes from selling products to other healthcareorganizations.
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Built to scale: Ed Sellers leads BlueCross BlueShield of SouthCarolina
May 1st 2006Every time a new stop light goes up in a growing neighborhood,BlueCross BlueShield of South Carolina (BlueCross) wants to have acustomer within a block of it. This health plan, nested withsubsidiary businesses, has prioritized growth through an aggressivebranching out from its core competencies. Half of its totalbusiness comes from selling products to other healthcareorganizations.
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Just mentioning "contract negotiations" can put plans and providers on the defensive or maybe even the offensive. The sometimes-contentious relationship between the two, triggered by the high cost of healthcare and complaints from providers about not being paid enough, escalates while both parties try to come to some kind of agreement.
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Enhance efficiencies through shared emergency room data
October 1st 2005The high cost of emergency department (ED) care is a concern for commercial and government insurers, hospitals, physicians and patients. Two-thirds of EDs operate at full capacity or over capacity, a situation exacerbated by increased ED visits from both insured and uninsured patients. Software applications that automate the ED can help improve patient outcomes and reduce costs. Payer organizations should be aware of four key adoption trends in ED automation.
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DM Web site goes beyond national guidelines to include real-world ideas
October 1st 2005While healthcare is highly competitive from a business perspective, when it comes to the actual delivery of care, everyone is on the same team. The ultimate goal is to provide the best possible care at the lowest possible cost, and that's exactly why the Cleveland Clinic created its Disease Management Project.
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Managing the Costs of Injectable Therapies: Do You Have the Right Game Plan? (PDF)
April 1st 2005About three years ago I asked a large group of health plan executives if they knew how much they spend annually for ?specialty pharmacy? products. Few could respond, and virtually none had launched any efforts to control the then unknown rapid increase in these costs.Today, this is not the case.
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On Finance: Costly pain of fibromyalgia can be reduced with holistic treatment
September 1st 2004Fibromyalgia is real and prevalent, yet many physicians and employers may inadvertently ignore or demean sufferers, not only at the cost of those with the condition, but at the cost of productivity and healthcare expenditures.
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Skirmishing continues over drug importing
August 1st 2004Washington, D.C. - Last month, the House approved legislation that would make it easier for Americans to obtain prescription drugs from Canada and other countries, similar to action it took last year. This time the legislators voted overwhelmingly to add to FDA's 2005 budget bill a provision that blocks FDA from enforcing a ban on drug reimportation. The drug import language is not expected to survive House-Senate negotiations on a final FDA spending bill, but it allows members of Congress to portray themselves as import advocates at election time.
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New molecular entity: Trospium
July 1st 2004The parasympatholytic action of trospium reduces the tonus of smooth muscle in the bladder by antagonizing the effect of acetylcholine on muscarinic receptors. Trospium was approved on May 28, 2004, for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
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Darifenacin: An M3-selective muscarinic antagonist for the treatment of overactive bladder
June 1st 2004Darifenacin (Enablex, Novartis) is a muscarinic antagonist in phase 3 clinical trials for the treatment of overactive bladder (OAB). Darifenacin demonstrates relative selectivity for the M3 muscarinic receptor subtype over the M1 and M2 subtypes. In clinical trials, darifenacin has been compared to placebo for the treatment of symptoms of OAB in adult men and women. Patients treated with darifenacin experienced significantly greater reductions in the number of incontinence episodes per week, nocturnal awakenings, and warning time before micturitions. It appears to have similar efficacy to available anticholinergic agents for the treatment of OAB. Commonly reported adverse events include dry mouth and constipation, and preliminary data suggest that darifenacin may be associated with decreased impairment of salivary flow versus oxybutynin. Darifenacin has not been found to have an effect on the cardiovascular system or cognition in clinical trials. Further research is needed to determine the efficacy of darifenacin compared to other available anticholinergic agents such as oxybutynin and tolterodine, as well as emerging therapies. In addition, further investigation of the adverse effect profile in elderly patients is warranted.
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Erectile dysfunction: A review and update
May 1st 2004Erectile dysfunction (ED) is now recognized as a common problem in men. Several medical problems, including diabetes mellitus, coronary artery disease, hypertension, and hyperlipidemia are known to increase the likelihood of developing ED. Diagnosis depends on an adequate history and physical examination. Several therapies are now available for the treatment of ED. With the advent of the phosphodiesterase type 5 (PDE5) inhibitors, therapy for ED has become more acceptable for many men. Oral therapy is usually the first-line treatment due to the ease of use and the effectiveness of this therapy. For men who do not respond to or have a contraindication to PDE5 therapy, intrapenile injection therapy, intraurethral therapy, and vacuum devices are effective alternatives.
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