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Reporter
USA
+3 year(s) experience
He has primarily written about advisory committees, FDA public meetings and drug regulation. He is also part of the Pink Sheet’s efforts to expand coverage into Latin America. Previously, Michael has covered generic drug and biosimilar regulation, as well as issues impacting clinical trials.
Pink Sheet
By Michael Cipriano 31 Oct 2018
If approved, ALKS 5461 would be first opioid-containing product to carry indication for depression; Alkermes CEO Pops tells Pink Sheet that agency's safety and efficacy concerns are surmountable because "all depression drugs have mixed results."
Pink Sheet
By Michael Cipriano 19 Jan 2018
In an interview with the Pink Sheet, Marks said the guidances on regenerative medicines make clear what the agency will be enforcing.
Pink Sheet
By Michael Cipriano 14 Sep 2017
US FDA Commissioner notes that combined-phase clinical trials could be expanded beyond oncology as one way of reducing drug development costs.
Pink Sheet
By Michael Cipriano 01 Sep 2017
Merck previously disclosed the clinical hold on the three trials at the beginning of July
Topic Clinical trials
Pink Sheet
11 Nov 2018
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08 Nov 2018
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07 Nov 2018
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02 Nov 2018
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02 Nov 2018
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01 Nov 2018
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30 Oct 2018
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29 Oct 2018
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26 Oct 2018
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24 Oct 2018
Medtech Insight
24 Oct 2018
Pink Sheet
23 Oct 2018
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16 Oct 2018
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08 Oct 2018
Pink Sheet
08 Oct 2018
