A new biologic, ranibizumab (Lucentis, Genentech), has just been cleared for age-related macular degeneration (AMD). A study of Medicare patients 65 years of age and older found that AMD increased substantially-from 5% to 27%-between 1991 and 1999. The American Academy of Ophthalmology estimates that more than 1.75 million Americans have AMD, with seven million more having earlier stages of the disease.
The Food & Drug Administration recently granted accelerated approval to dasatinib (Sprycel, Bristol-Myers Squibb) for the treatment of adults in all phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy-including imatinib (Gleevec, Novartis). The FDA also granted full approval to dasatinib for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib, considered an orphan drug for each of these indications, is currently available in retail pharmacies.
Despite the accelerating rate of HIV and AIDS on every continent, "only 12% of people in need of antiretroviral therapies in low- and middle-income countries are receiving them," said United Nations Secretary-General Kofi Annan in an opening address at a high-level conference on AIDS, held recently in New York. Thus, with treatment and prevention efforts being dubbed by Annan as "insufficient," Prezista (darunavir, Tibotec Therapeutics), the new protease inhibitor (PI), is being launched into an HIV market fraught with problems such as drug accessibility shortfalls and drug-resistant HIV.
According to a new report from the Institute of Medicine, medication errors harm at least 1.5 million people every year.
New antifungal therapies may help tame this growing problem and improve patient outcomes
The Florida Supreme Court recently added another brick to the increasingly solid legal wall of opinion that pharmacists have a duty to warn. The high court decision sent a lawsuit involving a drug overdose death against two pharmacies and a physician back to a lower court for trial.
Just a few years ago switching to a generic drug without consulting a physician or discussing it with the patient was a rare thing for a pharmacist to do. But the times are a-changin'.
Women with recurrent ovarian cancer will now have a new therapy option. Gemcitabine (Gemzar, Lilly) has been approved for use in combination with carboplatin for advanced ovarian cancer that has relapsed at least six months after initial therapy.
The law firm Hagens Berman Sobol Shapiro has filed a proposed class-action suit in the U.S. District Court of Arizona, alleging that CareMark Rx intentionally concealed revenue in order to avoid paying certain commissions owed to consultants who marketed and sold its services.
The FDA has approved Anthelio SX, a sunscreen from L'Oreal to be sold over-the-counter for the prevention of sunburn and for protection against ultraviolet B (UVB) and ultraviolet A (UVA) rays. It has a sun protection factor (SPF) of 15.
Abbott is reminding users of its FreeStyle and FreeStyle Flash blood glucose meters to check to make sure their meter is displaying the correct unit of measure (milligrams per deciliter, mg/dL) and strip calibration code each time they use their device. Abbott previously communicated that, in some cases, FreeStyle and FreeStyle Flash users could inadvertently change the units of measure on their meters when in setup mode
Medicare legislation sponsored by Reps. Marion Berry (D, Ark.) and Walter Jones (R, N.C.), known as H.R. 5182 or "the Medicare FAST Act," would increase Medicare costs by $55 billion over the next decade, according to a new analysis conducted by the Moran Co. and released by PCMA.
A bill (H.R. 5791) has been introduced in Congress that would require Medicare to cover all aspects of home infusion therapy under Part B. The Medicare Home Infusion Consolidated Coverage Act of 2006, which would cover drugs, supplies, and professional services, was introduced by Reps. Kay Granger (R, Texas), Eliot Engel (D, N.Y.), Randy Kuhl (R, N.Y.), and Tammy Baldwin (D, Wis.).
Millions of Medicare beneficiaries would face decreased access to DME such as wheelchairs and diabetes test strips if a proposed rule by CMS takes effect, according to NCPA. The association issued a statement saying "the so-called Competitive Acquisition Program developed by CMS creates huge administrative burdens for pharmacists that could affect the availability of DME, prosthetics, orthotics, and supplies, as well as Medicare Part B medications, immunizations, therapeutic shoes, diabetes supplies, and nebulizers.
Taking triptans to fight off a migraine together with either a selective serotonin reuptake inhibitor (SSRI) or a selective serotonin/norepinephrine reuptake inhibitor (SNRI) may lead to the development of serotonin syndrome, according to a new FDA warning. The three types of medications all raise the level of serotonin in the body and can lead to symptoms such as restlessness, loss of coordination, tachycardia, blood pressure changes, increased body temperature, nausea, vomiting, and diarrhea.
Women with recurrent ovarian cancer will now have a new therapy option. Gemcitabine (Gemzar, Lilly) has been approved for use in combination with carboplatin for advanced ovarian cancer that has relapsed at least six months after initial therapy.
RxUSA Wholesale has filed a $1.8 billion lawsuit against 16 drug manufacturers, five drug wholesalers, and the Healthcare Distribution Management Association. The New York-based distributor charged a conspiracy to boycott secondary wholesalers, eliminate competition, and maintain artificially high prices.
FFF Enterprises, a multidimensional healthcare corporation based in Temecula, Calif., announced that the company has been awarded Verified-Accredited Wholesale Distributors (VAWD) accreditation by NABP. FFF is a supplier of biopharmaceuticals, plasma products, vaccines, and clinical trial drugs.
The FDA has issued a warning against bismacine, also called chromacine, after use of the unapproved product led to one death, one hospitalization, and several injuries. The product contains high concentrations of bismuth and is not a pharmaceutical.
The PEG-enhanced version of L-asparaginase, pegaspargase (Oncaspar, Enzon Pharmaceuticals), has been approved by the FDA as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). The biologic was approved in 1994 only for patients with ALL who were allergic to L-asparaginase.
The FDA has given the go-ahead to EMD Chemicals, a division of Merck KGaA, to market pigments that make pharmaceuticals more ?sthetically pleasing. The pearlescent pigments can produce a metallic, stained, or shimmery finish in tablets and liquids, and they come in different colors.
A study published in the July 23 issue of Nature Medicine found that patients with chronic myelogenous leukemia (CML) receiving imatinib (Gleevec, Novartis) are at increased risk for heart failure. Researchers found that the ABL enzyme that is turned off by imatinib is actually a necessary component in maintaining the health of cardiac muscle cells.
Replacement enzyme idursulfase (Elaprase, Shire Human Genetic Therapies) has been approved by the FDA as the first treatment for Hunter syndrome (mucopolysaccharidosis II), a rare disease in which the body cannot produce iduronate-2-sulfatase. The enzyme is necessary to break down complex sugars produced in the body, and its deficiency can lead to growth delay, coarsening of facial features, and joint stiffness
A recently released report from the National Institute on Drug Abuse (NIDA) shows that effective treatment of drug abuse and addiction can take a bite out of crime and save communities money. Principles of Drug Abuse Treatment for Criminal Justice Populations is based on a review of the scientific literature on drug abuse treatment and criminal behavior, according to NIDA.
The Government Accountability Office has found that four genetic tests purchased from four Web sites mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers. GAO purchased tests from four Web sites and created fictitious consumers by submitting for analysis 12 DNA samples from a female and two samples from an unrelated male.
CollaGenex Pharmaceuticals received approval from the Food & Drug Administration in late May to market Oracea. According to the company, this is the first systemically delivered treatment for the treatment of rosacea. Affecting an estimated 14 million adults in the United States, rosacea is a dermatological condition characterized by papules and pustules, erythema, and telangiectasia.
Wal-Mart has agreed to sell Barr Pharmaceutical's Plan B emergency contraception in Connecticut. Wal-Mart will continue to allow pharmacists to refuse to fill the prescription and to refer customers to other pharmacies.
Disetronic Medical Systems and the FDA announced a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, which power the D-TRON Insulin Pump. There is the potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning.
Pharmacists may wake up to a rise in prescriptions for insomnia medication Rozerem (ramelteon), as Takeda Pharmaceuticals North America gets set to launch its first DTC campaign for the medication. The campaign, which includes print, on-line, and broadcast ads, carries the theme "Your Dreams Miss You."
California Senate Bill 1305 has been passed. The new law requires the proper disposal of home-generated sharps waste (syringes, needles, lancets, etc.) and acknowledges mail-back programs as one of the most convenient alternatives for the collection and destruction of home-generated sharps.
