Weekly Roundup 4.17.15

A few weeks ago it snowed, this week the lawn mowers were revved up. The car is covered in pollen. The cherry trees in DC have peaked. The ranks of tourists have swollen. Taxes have all been done and filed – hopefully. In short, Spring is well underway. Too soon, I fear, we will be complaining about the heat and humidity, but in the meantime, there is lots to enjoy.

I am working on some updates and fun things coming up.  In the meantime, here are a few things of import from the week past:

  • IMS Releases Report on Medicine Use – The IMS Institute for Healthcare Informatics announced the release of its report – Medicine Use and Spending Shifts: A Review of the Use of Medicines in the U.S. in 2014 which contains a wealth of data and information regarding the pharmaceutical industry and patient use of medicine. Among opther findings, the report found that total spending in the U.S. increased 10.3 percent on a real per capita basis in 2014 in addition to the fact that it was a year in which the highest number of transformative medicines were launched in a 10 year period. The numbers are also there tracking the proportion of specialty medicines (up in profile) and prices for branded products which rose an average of 13.5 percent (on an invoice basis) or 5-7 percent when accounting for off-invoice discounts and rebates. The report covers three primary subject matter areas: costs and spending; demand and payment and changes in treatment.
  • New Heart Failure Approval – FDA announced this week that it was approving Amgen’s Corlanor® (ivabradine) which is intended for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of the heart contractions. It is indicated for patients who have symptoms of heart failure that are stale, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest does they can tolerate. The drug is thought to work by decreasing heart rate and is the first approved drug in this class. It was reviewed under FDA’s priority review program and had fast track designation and will be dispensed with a Medication Guide. The company’s press release is here.
  • Generic Approval in Multiple Sclerosis – In another approval announced this week, FDA emphasized the message that a generic approval for Copaxone (glatiramer acetate injection) for the treatment of relapsing Multiple Sclerosis met the same rigorous standards of quality as the brand name drug. The announcement stated that Sandoz received the agency approval for marketing and the agency noted in its release that “the agency requires appropriate information to demonstrate sameness for complex active ingredients such as glatiramer acetate” and that FDA had established a thorough scientific approach. For additional coverage and background see the reporting from Ed Silverman on Pharmalot.

That’s it for me this week folks. Have a wonderful weekend.

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