Weekly Roundup 1-10-14

As we all emerge from the first full work-week of the new year, there is among many a sa strong shared sense that the last 5 days have actually been more like 5 weeks.  And even though it seemed like a long week, as weather stepped in to stifle human activity with fierce snows, biting winds and many, many cancelled flights, it also may seem like not much happened.  Nevertheless, as we ponder our progress on those New Year’s resolutions, here are a few things did happen and here are a few from our corner of the world:

  • FDA Approves New Type 2 Diabetes Drug – The first announced approval this year by FDA was Farxiga, a product jointly marketed by Bristol Myers Squibb and AstraZeneca.  The drug is a sodium-glucose co-transporter 2 (SGLT2) that blocks reabsorption of glucose by the kidney, increases glucose excretion and lowers blood glucose levels.  The press release from FDA stated that a whopping six different post-marketing reuirements have been slated for the drug:  a cardiovascular outcomes study; a bladder cancer risk study; a study on reduced urine flow; two pharmacokinetic studies for pediatric patients; and a pharmacovigilance program to monitor for specific adverse events.
  • First Gel Approved for Sealing Corneal IncisionFDA announced the approval of the first gel approved for sealing corneal incisions made after cataract surgery.  Apparently prior to this, stitches were the only option for closing a leaking corneal incision after cataract surgery.
  • Lots of FDA AdComm Scheduling – Though the tentative calendar for FDA AdComm meetings is up, it is still highly incomplete.  Nevertheless, there were several AdComms scheduled this week:  (1) a meeting of the Cardiovascular AdComm to consider approval for an NDA for a product that would reduce thrombotic cardiovascular events in patients with coronary artery disease undergoing PCI; (2) NDAC and the Pulmonary AdComms will meet to consider a replacement for Primatene Mist inhalers; (3) the Cardiovascular AdComm will meet to consider a BLA for a product to improve symptoms of acute heart failure; (4) the Arthritis and Risk Safety AdComms will meet to consider NSAIDS and cardiovascular risk labeling issues; and (5) there will be an Anesthesiology and Respiratory AdComm to consider approval for a sleep apnea device.
  • FDA Brings Back Defunct AdComm -Apparently for legal reasons you can read here, in 2002 FDA terminated the function of its Pharmacy Compounding Advisory Committee.  In the wake of receiving its new legal authorities to more closely regulate pharmacy compounding following the passage into law of the Drug Quality and Security Act of 2013, the committee is being re-established and the agency is taking nominations for members in the form of a voting consumer representative and for a non-voting industry representative.

That’s all for this extraordinarily long week.  Have a good weekend everyone.

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