Compounding caught in federal crosshairs
October 9th 2006With conflicting statements from the Food & Drug Administration, Centers for Medicare & Medicaid Services, and a Federal District Court judge, the definition and legality of pharmacy compounding once again seems headed to the Supreme Court or Congress for sorting out.
CMS sued for its Part D marketing guidelines
October 9th 2006A public interest law firm has sued the government over the restrictions placed on pharmacists and other healthcare providers in helping Medicare beneficiaries choose a Part D plan. The suit claims that the rules in the marketing guidelines are a violation of free speech.
MS: Promising therapies take new approaches
October 9th 2006We know that about 400,000 people in the United States currently suffer from multiple sclerosis (MS), and it's more common in women and Caucasians. We also know that early treatment of the condition makes a difference. Recently, we've read that Biogen Idec and Elan Corp. were given the go-ahead to reintroduce natalizu-mab (Tysabri) for the treatment of relapsing forms of MS. But beyond that, we haven't heard too much lately regarding the treatment of this devastating disease. What, if anything, coming down the pipeline looks promising? Here are a few of the possibilities.
Initial HIV regimens updated in guidelines
October 9th 2006All symptomatic patients with HIV disease should begin antiretroviral therapy right away, according to new guidelines published by the International AIDS Society-USA and presented at the International AIDS Conference held in August in Toronto. Based on several new developments, the revision marks the seventh time since 1996 that the organization has updated its recommendations for HIV treatment.
FDA/Duke Clinical Research Institute join forces
October 2nd 2006The Duke Clinical Research Institute in conjunction with the FDA will create a virtual electronic database of more than 200,000 electrocardiograms (ECGs) in order to identify as early as possible the potential effects that drugs and devices may have on the heart.
New warnings released for colorectal cancer drug
October 2nd 2006Rare cases of a brain-capillary leak syndrome called reversible posterior leukoencephalopathy syndrome have led to a revision in the Warnings and Adverse Reactions sections of the prescribing information for bevacizumab (Avastin, Genentech).
Rite Aid, Lindora to debut healthcare clinics
October 2nd 2006Lindora, which is recognized for its medically supervised weight management programs in Southern California, and Rite Aid have announced an agreement to open the first in-store healthcare clinics that will also offer medically supervised treatment for weight control.
Pediatricians speak out against retail-based clinics
October 2nd 2006The American Academy of Pediatrics has issued the following policy statement opposing the use of retail-based clinics located in supermarkets, pharmacies, and large retail stores: ?These clinics do not support AAP?s commitment to the medical home model that provides accessible, family-centered, comprehensive, continuous, coordinated, compassionate, and culturally effective care for which the pediatrician shares responsibility with the family.?
Perrigo continues Clay-Park conversions
September 25th 2006In its ongoing effort to bring Clay-Park Labs products under the Perrigo brand, Perrigo recently announced 12 more product conversions. While most product changes will not affect NDC, UPC, and outer case pack dimensions, the company also created new NDCs for two triamcinolone products.