June 17th 2021
The COX-2 inhibitor Anjeso, a faster-acting injectable formulation of meloxicam, reduces opioid use after surgery.
November 18th 2014
June 13th 2013
June 12th 2013
FDA faces congressional probes and more transparency and organizational changes
February 1st 2011With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are contemplating broad federal budget cuts and much more aggressive oversight of administration health policy and regulatory programs.
FDA: Dolasetron mesylate IV no longer indicated for CINV
February 1st 2011Intravenous dolasetron mesylate (Anzemet) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in adult or pediatric patients due to an associated dose-dependant increase in QTc prolongation, according to a recent FDA drug safety communication.
Recombinant HPV Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
February 1st 2011New indication: Recombinant HPV quadrivalent (types 6, 11, 16, and 18) vaccine (Gardasil) was approved for the prevention of anal cancer and associated precancerous lesions due to HPV in persons aged 9 to 26 years.
FDA: Severe liver injury associated with dronedarone use
January 14th 2011Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.
Combination improves human epidermal growth factor receptor 2-positive breast cancer response rates
January 1st 2011A combination of lapatinib, trastuzumab, and paclitaxel significantly improved tumor response rates in patients with human epidermal growth factor receptor 2-positive breast cancers, according to a new study presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.
Early rheumatoid arthritis treatment with rheumatologist improves disease outcomes
January 1st 2011Patients with rheumatoid arthritis who are seen by a rheumatologist within 12 weeks of symptom onset were likely to experience less joint destruction and have a higher chance of achieving disease modifying anti-rheumatic drug-free remission, according to a new study published December 2010 in Arthritis & Rheumatism.
Angiotensin receptor blockers may not reduce mortality in diabetes, hypertension settings
January 1st 2011Antihypertensive therapy with an angiotensin receptor blocker is not associated with reductions in cardiovascular or all-cause mortality compared to non-ARB-based regimens in patients with type 2 diabetes, according to researchers at the Massachusetts College of Pharmacy and Health Sciences.
Protease inhibitor saquinavir linked to QT, PR interval prolongation
January 1st 2011FDA is requiring a new warning be added to the prescribing information for saquinavir (Invirase) detailing the drug's potential to prolong both QT and PR intervals on an electrocardiogram, and thus potentially cause the dangerous abnormal heart rhythms called torsades de pointes and complete heart block.
Oncology benefit management undergoing an evolution
January 1st 2011Oncology treatment and benefits are changing. Buy-and-bill, the traditional methodology that had physicians buy chemotherapeutic products, treat in the office, and bill the payer, is going the way of surgery by barbers. But no one is quite sure what will replace the one-time standard of payment.
Pfizer voluntarily withdraws sitaxsentan from the market worldwide and halts ongoing clinical trials
January 1st 2011Based on "a review of emerging safety information from clinical trials and postmarketing reports," Pfizer announced it would be voluntarily withdrawing sitaxsentan (Thelin), the manufacturer's pulmonary artery hypertension (PAH) treatment from the market worldwide.