At the 2009 annual meeting of the Generic Pharmaceutical Association (GPhA) in February, House Energy and Commerce Committee Chairman Henry Waxman told attendees that a workable scientific, regulatory, and legal pathway for follow-on biologics (also referred to as biogenerics or biosimilar pharmaceuticals) would lead to more affordable medications for Americans.
Catheter delivery of tissue plasminogen activator (t-PA) improves survival and functional outcomes at 6 months in patients with intraventricular hemorrhage (IVH), according to the final results from a phase 2b study known as Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR IVH).
OPKO Health announced that it is terminating a phase 3 trial of bevasiranib for the treatment of wet age-related macular degeneration (wet-AMD).
ViroPharma has announced that it is discontinuing a phase 3 trial of maribavir for prophylaxis against cytomegalovirus (CMV) disease in patients undergoing a liver transplant.
In a decision handed down March 4, 2009, the U.S. Supreme Court ruled in favor of Levine in the court case Wyeth v Levine, upholding the ruling of the Vermont Supreme Court. This decision may set a precedent for rejecting the argument of pre-emption, a tenet holding that FDA regulations connected with drug approvals and medication safety supersede state laws.
In a news conference on March 2, President Obama nominated Kansas Governor Kathleen Sebelius to the post of secretary of Health and Human Services (HHS). He also nominated Nancy Ann DeParle to the post of director of the White House Office for Health Reform.
In a study published in the Journal of the American Medical Association, investigators demonstrated an association between treatment with the anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies (mAbs) adalimumab and infliximab and risk of herpes zoster events in patients with rheumatoid arthritis (RA).
In a retrospective cohort study published in the Archives of Internal Medicine, higher continuity of statin treatment was associated with a lower risk of all-cause mortality among patients with or without coronary heart disease (CHD).
A prominent theme in health-reform efforts is the need for more transparent information about healthcare cost and quality upon which providers and patients can base their treatment decisions. Many federal agencies and state governments are expanding their requirements for pharmaceutical companies to report payments made to researchers and physicians, and for health plans to give beneficiaries more information on drug costs and coverage.
Although there have been significant advances in prevention, diagnosis, treatment, and education, the occurrence of sexually transmitted diseases (STDs) continues to increase. This article focuses on the diagnosis and treatment of the most common STDs.
Generic drugs approved by FDA (through March 2009) including sumatriptan tablets, divalproex extended-release tablets, and risperidone oral solution
Recent FDA approvals (through March 2009) related to Gelnique, RiaSTAP, and Kapidex
Recent FDA action (through March 2009) related to cetuximab, prasugrel, risperidone, iclaprim, lasofoxifene, ecallantide, laquinimod, C1 inhibitor, SGN-35, and omacetaxine
Ustekinumab is a novel investigational human monoclonal antibody (mAb) that is pending approval for the treatment of plaque psoriasis. Subcutaneous administration of ustekinumab has demonstrated efficacy in both phase 2 and 3 trials.
New formulation: Calcitriol (Vectical), a Vitamin D analogue, was approved on January 23, 2009, for the treatment of mild-to-moderate plaque psoriasis
New biologic: Antithrombin (recombinant) (ATryn), a recombinant human antithrombin, was approved on February 6, 2009, for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients
Agents in late-stage development for the treatment of asthma, COPD, and PAH
The problems exposed in California reveal the need for focus on state rescission guidelines
Organizations need to use levers to build financial value for health investments
Performance registries are designed for data collection in reporting to CMS or potentially other payers
Insist that the expected value of improvements in information quality is expressed in dollar figures
The potential is there if you only seek the benefits
Some employers might need to adjust copay structures overall to achieve adequate compliance.
One way to level the playing field is to offer the public plan through an administered market system.
Payers have vast amounts of data that could be used in so many ways, if only HIPAA would allow it
Research must be actionable, relevant, timely, translated and transparent in its funding sources.
Key provisions include funding for Mediciad, COBRA subsidies, health records, NIH research, health centers, effectiveness research, and wellness programs.
Regina Herzlinger's prescription for reform calls for payment based on episodes of care.
Expected losses of delayed IT projects include improved quality, efficiency and care coordination
Your competitive edge can come from digitizing and automating labor-intensive processes to gain efficiencies