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Reporter
USA
+4 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 16 Jan 2019
FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.
Topic FDA
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
16 Jan 2019
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15 Jan 2019
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14 Jan 2019
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12 Jan 2019
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10 Jan 2019
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09 Jan 2019
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09 Jan 2019
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08 Jan 2019
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03 Jan 2019
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02 Jan 2019
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31 Dec 2018
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12 Dec 2018
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11 Dec 2018
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09 Dec 2018
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03 Dec 2018
