CMS likely will not restrict Medicare coverage for drug-coated stents in response to recent concerns that they can increase risk for blood clots.
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Democrats reintroduced legislation that would require the federal government to negotiate prices directly with pharmaceutical companies for medications under the Medicare prescription drug benefit.
PharmaMeal's new service allows medical professionals to create an online profile which includes important delivery information as well as staff meal preferences.
Senate Finance Committee introduced a bill that would reverse a CMS decision to limit Medicare coverage for use of anemia medications.
Orphan Australia Pty Ltd, dedicated to providing novel, highly specialized pharmaceuticals, has been granted registration approval by the Therapeutic Goods Administration for DepoDur in Australia. DepoDur, which was developed by and licensed from Pacira Pharmaceutical, Inc. and utilizes Pacira's DepoFoam technology, is a novel, single dose modified-release formulation of morphine.
FDA and the European Medicines Agency (EMEA) independently reviewed Sequella lead drug compound, SQ109, and both agencies granted SQ109 orphan drug status for the treatment of tuberculosis. SQ109 shows excellent in vitro and in vivo activity against drug-susceptible and drug-resistant TB bacteria, including XDR-TB.
Further, SQ109 synergizes with other TB drugs in experimental animal models of TB, and could result in new TB drug combinations that have much greater activity than the current standard of care.
Renal Solutions has received 510(k) clearance from FDA for its newly enhanced Allient Sorbent Hemodialysis System in chronic and acute hemodialysis applications. The new Allient System features improvements in ease of manufacturing, service and user-friendliness. In preparation for the Allient System commercialization, Renal Solutions is also launching its SMARRT (Sorbent Management for Advanced Renal Replacement Therapy) platform and campaign, which will introduce the benefits of advanced sorbent therapy to the renal community.
FDA has granted marketing approval for Genzyme's Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
Summaries examine E-prescribing for Medicare prescription drug benefit and coverage related to e-health.
A panel of the European Medicines Agency has recommended for approval the once-daily antiretroviral drug Atripla.
With safety issues making headlines, pharmaceutical and medical device manufacturers face a rugged regulatory landscape. Organizations are relying on their quality function to navigate regulatory difficulties that could affect production. Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7.
Scientists have just solved the structure of the first mammalian GRP94 protein implicated in immune diseases such as sepsis, AIDS and certain cancers. His work is being published today in a cover article in a top scientific journal -- Molecular Cell.
FDA approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD).
FDA has granted licensure to expand the indication for Sanofi Pasteur's meningococcal conjugate vaccine.
National Institutes of Health to develop low-cost health-care technologies aimed at the medically underserved.
FDA has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections. Doripenem injection, sold under the trade name Doribax, has been shown to be active against several strains of bacteria.
"This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.
FDA expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.
Independent pharmacists urged lawmakers to pass legislation that would exempt small pharmacies from antitrust laws and allow them to collaboratively negotiate reimbursements with health insurers and pharmacy benefit managers.
Helminth infections are responsible for a huge health burden on developing country populations, and the number of drugs available to treat them is incredibly limited.
Congress was asked not to intervene in a recent decision by CMS that will limit Medicare coverage for use of anemia medications.
U.S. lawmakers should not praise Thailand and other countries for issuing compulsory licenses to manufacture generic versions of patented antiretroviral drugs.
FDA supports a recent decision by CMS that will limit Medicare coverage for use of anemia medications.
Baltimore Sun examined how adult drugs are routinely prescribed for children despite the fact that most have never undergone clinical testing for children.
Baxter International has signed an agreement with Kaketsuken, the Chemo-Sero-Therapeutic Research Institute, for the worldwide rights to develop, manufacture and market the recombinant protein ADAMTS13.
Independent pharmacists express concerns about a rule finalized in July by CMS that will reduce Medicaid reimbursements to pharmacies for generic medications.
Medi-Promotions launched next generation prescription pad model -- Medi-Scripts PLUS. Building on the 27-year success of its Medi-Scripts prescription pad service model, Medi-Scripts PLUS will include patient offers on behalf of its advertisers whom leverage the list of more than 200,000 Medi-Scripts prescribers requesting and using its prescription pads free of charge in their practices on a daily basis.
Genencor announced a new product, Accellerase 1000, the first ever commercially available biomass enzyme developed specifically for second generation biorefineries. Accellerase 1000 contains a potent complex of enzymes that reduces complex lignocellulosic biomass into fermentable sugars -- an indispensable step for the production of cellulosic ethanol.
FDA Office of Orphan Products Development has granted orphan drug designation to Knopp Neurosciences's KNS-760704 for the treatment of amyotrophic lateral sclerosis (ALS).
Under means testing proposal by the Bush administration higher-income Medicare beneficiaries would have to pay higher premiums and deductibles under the prescription drug benefit.