FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans
October 21st 2011FDA Commissioner Margaret A. Hamburg, MD, recently released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.
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Generic inhaled corticosteroids: Current status and what to expect next
October 21st 2011Tracking and preparing for the approval of generic products is 1 of the key components of proactive formulary management. Unfortunately, forecasting FDA approval of the first generic inhaled corticosteroid products is difficult.
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FDA approves bupivacaine hydrochloride injection, USP
October 20th 2011FDA has approved bupivacaine hydrochloride injection, USP (Sagent and Strides Arcolab), a local or regional anesthetic, for use in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.
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Cigna will acquire FirstAssist Insurance Services, a travel and protection insurance company based in the United Kingdom, from Barclays Private Equity. The acquisition will add a new product line to Cigna's global portfolio, enabling the company to expand its individual business.
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Annual premiums for employer-sponsored family health coverage increased 9% from last year, according to the Kaiser Family Foundation/Health Research & Educational Trust 2011 Employer Health Benefits Survey. That's more than four times the average increase in workers' wages and nearly triple the rate of inflation.
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FDA approves sitagliptin and simvastatin combination therapy
October 7th 2011FDA has approved sitagliptin and simvastatin (Juvisync, MSD International GmbH Clonmel), a fixed-dose combination prescription medication that contains 2 previously approved medications in 1 tablet for use by adults who need both sitagliptin and simvastatin.
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Drug companies should report clinical trial results, even when they won't lead to a product
October 1st 2011Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research, even when product development is no longer being pursued.
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Dapagliflozin: An emerging treatment option for type 2 diabetes mellitus
October 1st 2011Dapagliflozin is a sodium glucose co-transporter inhibitor under review for FDA approval for the treatment of type 2 diabetes mellitus. Despite the availability of many antidiabetic agents in the United States, type 2 diabetes remains inadequately controlled in many patients.
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Recent FDA action (through September 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001, cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127
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Labels for TNF-alpha blockers to warn of potential for infection
October 1st 2011In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.
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