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.
Biologic treatment of RA associated with increased risk of nonmelanotic skin cancer and melanoma
January 1st 2008The use of biologic treatment for rheumatoid arthritis (RA) is associated with an increased risk of nonmelanotic skin cancer and melanoma, according to a large observational study published that included 13,001 patients.
FDA actions in brief, January 2008
January 1st 2008FDA-related information through January 2008 for sorafenib (Nexavar), aripiprazole (Abilify), rosuvastatin (Crestor), irbesartan/hydrochlorothiazide (Avalide), extended-release quetiapine (Seroquel XL), delayed-release oral suspension of pantoprazole (Protonix), lopinavir/ritonavir (Kaletra), and dasatinib (Sprycel)
Pipeline Preview, January 2008
January 1st 2008FDA-related information through January 2008 on Extended-release ropinirole (Requip XL); Indiplon; Xience V Everolimus Eluting Coronary Stent System; tetrabenazine; vernakalant (Kynapid); gepirone extended-release; lovastatin (Mevacor); bevacizumab (Avastin); tedisamil; rabies monoclonal antibody cocktail; AVI-4658; alfimeprase; Prochymal; aripiprazole (Abilify); bendamustine (Treanda); ATIR; CDX-110; and ISIS 333611
Increased need for pacemaker insertion demonstrated among women treated with amiodarone for AF
December 1st 2007According to the results of a prospective cohort study of 1,005 patients with new-onset atrial fibrillation (AF), women who are treated with amiodarone are at greater risk for bradyarrhythmia requiring pacemaker insertion than men who are treated with the drug.
Clinical news updates from the 2007 AHA Scientific Sessions
December 1st 2007The 2007 American Heart Association (AHA) Scientific Sessions took place November 3 to 7, 2007, in Orlando, Florida. Among the new data presented were the much anticipated results of a phase 3 trial of prasugrel versus clopidogrel in patients scheduled for percutaneous coronary intervention (PCI). Other clinical trials of note were the first prospective study of a statin in patients with ischemic heart disease and heart failure and a comparison of eptifibatide with abciximab on ST-segment resolution in patients with myocardial infarction (MI) who are undergoing primary PCI. This AHA Special Report details these and other trials.
Doripenem: A new extended-spectrum carbapenem antibiotic
December 1st 2007Doripenem is a carbapenem antibiotic recently approved for the treatment of complicated intra-abdominal infections (IAIs) and complicated urinary tract infections (UTIs), including pyelonephritis. An NDA has also been submitted for the use of doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Doripenem is the fourth carbapenem approved for use in the United States and exhibits many pharmacologic similarities with imipenem/cilastatin and meropenem. Doripenem has a broad spectrum of activity against various gram-positive and gram-negative aerobic and anaerobic bacteria, including many multidrug-resistant gram-negative pathogens. Improved potency against nonfermentative gram-negative bacteria has also been demonstrated with doripenem compared with other carbapenems. In clinical trials, doripenem was generally well tolerated; headache, nausea, diarrhea, and phlebitis were the most commonly reported drug-related adverse events. Because doripenem exhibits..
FDA actions in brief, December 2007
December 1st 2007FDA-related information through December 2007 for nilotinib (Tasigna), sitagliptin (Januvia), SymlinPen120, SymlinPen60, terbinafine (Lamisil), diclofenac (Voltaren Gel), sevelamer (Renvela), brimonidine/timolol (Combigan), Zingo, Totect, Menactra, FluMist, ACAM2000, Afluria, palonosetron injection (Aloxi), bortezomib (Velcade), certuximab (Erbitux), alemtuzumab (Campath), fosamprenavir (Lexiva), and tipranavir (Aptivus)
Topotecan: Oral chemotherapy agent approved for the treatment of relapsed SCLC
December 1st 2007This oral formulation of topotecan was approved on October 12, 2007, for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response who are ≥45 days from the end of first-line chemotherapy.
Adding prostaglandin blocker to niacin ER reduces flushing without compromising effects on lipids
November 1st 2007An investigational drug that combines niacin extended-release (ER) and laropiprant, a prostaglandin D2 receptor antagonist, reduces the flushing that often leads to niacin ER discontinuation while preserving the agent's beneficial effects on lipids, according to lead author Darbie Maccubbin, PhD, Merck Research Laboratories, Rahway, New Jersey, et al. The results of this research were presented at the European Society of Cardiology Congress 2007 in Vienna, Austria, September 1 to 5, 2007. The drug is pending FDA approval.
MERLIN: Ranolazine associated with antiarrhythmic effect
November 1st 2007In a prespecified secondary analysis of the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes (MERLIN)-TIMI 36 trial, ranolazine was associated with a reduction in the number of episodes of ventricular tachycardia and supraventricular tachycardia. The results of the analysis were presented at the European Society of Cardiology Congress 2007 in Vienna, Austria.
GRACE and SCAAR add to the debate about stents
November 1st 2007Questions about the safety of drug-eluting stents (DES) versus bare metal stents (BMS) persisted after 2 studies presented at the European Society of Cardiology (ESC) Congress 2007 in Vienna, Austria, demonstrated varying effects of DES and BMS on long-term mortality.
Use of SSRIs in early pregnancy not associated with increased risk of most birth defects
November 1st 2007In 2 large, case-control studies published in the New England Journal of Medicine (NEJM), researchers demonstrated that, overall, a woman's use of a selective serotonin-reuptake inhibitor (SSRI) in early pregnancy was not associated with significantly increased risks of congenital heart defects or most other types of birth defects.