A bit early this week and back after a brief hiatus, but here is another installment of the BiotechDueDiligence weekend biotech reading list.
President Obama released his proposal fiscal year 2014 government budget. What does it mean for the FDA, the biotech/pharmaceutical industry, and drug development? Two takes:
Interpreting the President’s FY 14 Budget for FDA
Alliance for a Stronger FDA
The President’s FY 2014 Budget Continues Push to Curb Patent Settlement Agreements, Shorten Biologics Exclusivity
FDA Law Blog
A brutal and effective rebuttal of Myriad Genetics BRCA patent claims by a former colleague on the faculty at Johns Hopkins (Steven Salzberg - Forbes contributor)
Myriad Genetics CEO Claims He Owns Your Genes
The FDA made big news regarding generic versions of the pain killer Oxycontin this week. Here is your full coverage:
FDA News Release
The Science of Abuse-Deterrence – Progress Toward Creating Safer Opioids (FDA Voice official blog)
“Opioid Spring” Blossoms: FDA Finds “Original” OXYCONTIN Discontinued for Safety or Effectiveness Reasons; Will Not Accept or Approve ANDAs (Analysis from FDA Law Blog)
If you are interested in oncology drug development or enjoyed coverage of the recent AACR Annual Meeting, be sure to check out the numerous follow-up / takeaway blog posts from Pieter Droppert and Sally Church of Icarus Consultants.
Pharma Strategy Blog
Biotech Strategy Blog
Interpreting the President’s FY 14 Budget for FDA
Alliance for a Stronger FDA
The President’s FY 2014 Budget Continues Push to Curb Patent Settlement Agreements, Shorten Biologics Exclusivity
FDA Law Blog
A brutal and effective rebuttal of Myriad Genetics BRCA patent claims by a former colleague on the faculty at Johns Hopkins (Steven Salzberg - Forbes contributor)
Myriad Genetics CEO Claims He Owns Your Genes
The FDA made big news regarding generic versions of the pain killer Oxycontin this week. Here is your full coverage:
FDA News Release
The Science of Abuse-Deterrence – Progress Toward Creating Safer Opioids (FDA Voice official blog)
“Opioid Spring” Blossoms: FDA Finds “Original” OXYCONTIN Discontinued for Safety or Effectiveness Reasons; Will Not Accept or Approve ANDAs (Analysis from FDA Law Blog)
If you are interested in oncology drug development or enjoyed coverage of the recent AACR Annual Meeting, be sure to check out the numerous follow-up / takeaway blog posts from Pieter Droppert and Sally Church of Icarus Consultants.
Pharma Strategy Blog
Biotech Strategy Blog
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