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All News - Page 184
Physicians urged to return to statins after announcement of ENHANCE results
May 1, 2008
Experts urged a “return to statins” after hearing the final results of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial, which demonstrated no slowing of carotid atherosclerosis progression with the addition of ezetimibe to simvastatin therapy.
Drug Watch: Antibiotics in late-stage development (May 2008) (PDF)
May 1, 2008
Antibiotics in deveopment for the treatment of complicated skin and skin structure infections, community-acquired pneumonia, and infectious diarrhea
ONTARGET: ARB noninferior to ACE inhibitor in patients with cardiovascular disease
May 1, 2008
According to results from the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), the angiotensin receptor blocker (ARB) telmisartan is as effective as the angiotensin-converting enzyme (ACE) inhibitor ramipril in preventing adverse cardiovascular events in high-risk patients with cardiovascular disease but without heart failure.
Medicare commission explores national reporting of industry gifts to physicians; House expands mental health coverage
May 1, 2008
At a March 5, 2008, commission meeting, the Medicare Payment Advisory Commission (MedPAC) discussed the feasibility of requiring pharmaceutical companies and medical product manufacturers to report financial relationships and gifts to physicians on a national basis.
High- and low-tech solutions to reduce the incidence of hospital-acquired infections and antibiotic resistance
May 1, 2008
Approximately 1.7 million healthcare-associated infections (HAIs) occur in US hospitals each year. These HAIs, which include pneumonia, bloodstream infections (BSIs), and urinary tract infections (UTIs), account for approximately 99,000 deaths and $5 billion in additional healthcare costs.
CDER gains Woodcock as permanent chief
May 1, 2008
Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.
Research disclosure and drug safety monitoring requirements raise new challenges
April 3, 2008
The Food and Drug Administration Amendments Act (FDAAA) enacted in September 2007 requires new initiatives to expand information on the risks and benefits of prescription drugs. One goal established in FDAAA is the modernization of FDA’s system for detecting adverse drug events (ADEs); therefore, the current system is being reviewed so limitations and capabilities can be identified.
International Stroke Conference 2008: EPITHET: Patients who suffer a stroke and have a perfusion-diffusion mismatch may benefit from tPA beyond the 3-hour window
April 1, 2008
Data from EPITHET presented at the International Stroke Conference 2008 demonstrates that extending the standard 3-hour window for tPA could benefit patients who suffer a stroke and have a perfusion-diffusion mismatch.
Medication safety labeling updates and new warnings, April 2008
April 1, 2008
Label updates and warnings through April 2008 related to epoetin alfa and darbepoetin alfa, darunavir, and tiotropium.
Off-label stent use: DES associated with equal safety risks and reduced risk of repeat PCI compared with BMS
April 1, 2008
Study shows no significant differences in safety risks between off-label use of drug-eluting stents (DES) and off-label use of bare-metal stents (BMS) and a decreased risk of repeat PCI with use of off-label BMS.
Process steps and suggestions for creating drug monographs and drug class reviews in an evidence-based formulary system
April 1, 2008
How-to guide for creating drug monographs and drug class reviews for evidence-based formulary consideration.
DPP-IV inhibitors: A review of sitagliptin, vildagliptin, alogliptin, and saxagliptin
April 1, 2008
Treatment of diabetes with DPP-IV inhibitors; sitagliptin, vildagliptin, alogliptin, and saxagliptin.
First-time generic drug approvals, April 2008
April 1, 2008
Generic drugs approved by FDA (through April 2008) including cefuroxime for oral suspension, pramipexole tablets, alendronate once-daily tablets, and alendronate once-weekly tablets.
FDA actions in brief, April 2008
April 1, 2008
Recent FDA approvals and indications (through April 2008) related to Xyntha, Simcor, Aloxl, Humira, Abilify, Avastin, Nexium, and Luvox.
FDA Pipeline preview, April 2008
April 1, 2008
Recent FDA action (through April 2008) related to Rotavirus vaccine, live, oral; istradefylline; olanzapine long-acting injection; mycobacterial cell wall-DNA complex; talactoferrin; levodopa/carbidopa intestinal gel; prasugrel; eltrombopag; difluprednate ophthalmic emulsion; EUR-1008; ARG201; MGCD0103; triphendiol; ADH-1; and levofloxacin solution for inhalation.
Rilonacept (Arcalyst): Interleukin-1 blocker approved for the treatment of cryopyrin-associated periodic syndromes (CAPS)
April 1, 2008
New biologic: Rilonacept (Arcalyst), a regeneron Interleukin-1 blocker was recently approved for the treatment of cryopyrin-associated periodic syndromes (CAPS).
Desvenlafaxine (Pristiq): Selective serotonin and norepinephrine reuptake inhibitor approved for the treatment of major depressive disorder
April 1, 2008
NME: Desvenlafaxine (Pristiq), a selective serotonin and norepinephrine reuptake inhibitor was recently approved for the treatment of major depressive disorder.
Drug Watch: Agents in late-stage development for the treatment of selected neurodegenerative disorders (April 2008) (PDF)
April 1, 2008
Drugs in development for the treatment of Huntington disease, Parkinson disease, and amyotrophic lateral sclerosis
Bevacizumab plus paclitaxel can slow breast cancer progression but does not improve overall survival
March 11, 2008
Adding bevacizumab to treatment with paclitaxel does not prolong overall survival among patients with metastatic breast cancer; however, the combination therapy is associated with a significant improvement in progression-free survival, according to the results of a trial published in the New England Journal of Medicine (NEJM).
The pharmacologic management of Crohn's disease
March 1, 2008
This article discusses pharmacologic options for the treatment of Crohn's disease, including aminosalicylates, corticosteroids, immunosuppresant agents, and biologic agents.
First-time generic drug approval, March 2008
March 1, 2008
First-time generic approval: Balsalazide capsules
FDA actions in brief, March 2008
March 1, 2008
A summary of drugs and indications recently approved by FDA: Intelence, Alvesco Inhalation Aerosol, Moxatag, Humira, Asmanex, Tekturna HCT, Herceptin
FDA pipeline preview, March 2008
March 1, 2008
FDA-related information through March 2008 on C1 inhibitor, ferric carboxymaltose injection, lovastatin, carbidopa/levodopa extended release, vigabatrin, bortezomib, peginterferon alfa-2b, elesclomol, triphendiol, VQD-002
Colesevelam: Bile acid-binding agent approved to improve glycemic control in adult patients with type 2 diabetes
March 1, 2008
Colesevelam (Welchol) was approved on January 18, 2008, as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.
Medication Safety: Labeling updates and new warnings, March 2008
March 1, 2008
Labeling changes and safety information regarding Botox, selected antiepileptic drugs, Chantix, and Ortho Evra (through March 2008)
Etravirine: A non-nucleoside reverse transcriptase inhibitor for the treatment of resistant HIV-1 infection
March 1, 2008
Etravirine is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) that was approved January 18, 2008, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to NNRTIs and other antiretroviral agents.
Drug Watch: Agents in late-stage development for the treatment of selected ophthalmic disorders (March 2008) (PDF)
March 1, 2008
A review of agents in late-stage development as of March 2008 for the treatment of diabetic retinopathy, dry eye syndrome, macular degeneration, and diabetic macular edema
