March 1st 2022
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
FDA pipeline preview, September 2007
September 1st 2007The latest FDA action (through September 2007) related to satraplatin, ropinirole (Requip CR), sumatriptan/naproxen (Trexima,) desvenlafaxine (Pristiq), eprodisate (Kiacta,) raloxifene (Evista), natalizumab (Tysabri), bifeprunox, fluticasone/salmeterol inhalation powder (Advair Diskus 500/50), LX211, TZP-101, Alferminogene tadenovec, Ad5FGF-4 (Generx), tramiprosate (Alzhemed), rilonacept, aripiprazole (Abilify), sapropterin (Kuvan), oral topotecan (Hycamtin), mifepristone (Corlux), vitiligo-derived IgG (VitiGam)
FDA advisory panel votes to keep rosiglitazone on market, but not without caveats
August 1st 2007An FDA advisory panel voted nearly unanimously to recommend that rosiglitazone (Avandia, GlaxoSmithKline) should remain on the market despite being in overwhelming agreement that the drug increases the risk of ischemic heart disease.
Bare-metal and drug-eluting stents yield similar cardiac event risks, according to pooled analysis
August 1st 2007A pooled analysis involving 1,748 patients in 4 randomized trials contradicts the results of recent trials that have demonstrated that the risks for death and myocardial infarction (MI) are potentially higher in patients receiving drug-eluting stents (particularlysirolimus-eluting stents) compared with patients receiving bare-metal stents.
Patients with cancer and ACS, with or without thrombocytopenia, may benefit from use of aspirin
August 1st 2007In a small, retrospective, case-control study, it was demonstrated that aspirin (ASA) improved 7-day survival in patients with cancer who developed acute coronary syndrome (ACS), with or without thrombocytopenia.
Lamotrigine, valproate emerge as superior epilepsy treatment options as assessed in SANAD trial
August 1st 2007The results of the Standard and New Antiepileptic Drugs (SANAD) trial, an unblinded, randomized, controlled, 2-arm study comparing the efficacy of various epilepsy drugs showed that for treatment of patients with partial seizures, lamotrigine demonstrated superior efficacy.
ADAPT: Naproxen and celecoxib demonstrated to be ineffective in primary prevention of AD
August 1st 2007Use of naproxen or celecoxib does not prevent Alzheimer's disease (AD), at least within the early years after treatment initiation, according to a randomized, placebo-controlled, multicenter study.
Vernakalant: A novel antiarrhythmic agent for the treatment of atrial fibrillation
August 1st 2007Atrial fibrillation (AF) is a disorder that affects >2 million people in the United States. Firstline antiarrhythmic agents (per American College of Cardiology/American Heart Association/European Society of Cardiology guidelines) that are currently used to treat recent-onset AF work by indiscriminately blocking various ionic channels, thereby inducing a prolonged ventricular action potential duration or possibly inducing ventricular arrhythmias in the presence of myocardial ischemia because of excessive conduction slowing in diseased cardiac tissue. Vernakalant is an atrial-selective, potassium and sodium-channel-blocking agent awaiting FDA approval for the indication of conversion of recent-onset AF to normal sinus rhythm.
Dr von Eschenbach's vision: FDA's newest commissioner faces multiple challenges
August 1st 2007Andrew von Eschenbach, MD, has faced a number of tough issues since he was sworn in as FDA's commissioner in December 2006, not the least of which is drug safety. Fewer new drugs have been coming to market, and pressure continues to mount for FDA to do more with limited resources. Legislation to reauthorize user fees for pharmaceutical and medical device manufacturers has to be approved by Congress by September 30, 2007, or FDA will have to lay off hundreds of staff members. The need for speedy legislative action has focused public attention on agency operations and policies, a trend likely to continue as the nation's healthcare system and prescription drug costs become a central issue in next year's presidential elections.
DAD study: Use of protease inhibitors increases risk of myocardial infarction
August 1st 2007In a prospective, observational study, exposure to protease inhibitors (PIs) was associated with an increased risk of myocardial infarction (MI). The authors stated that this association is partly explained by dyslipidemia.
FDA pipeline preview, August 2007
August 1st 2007The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135