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Reporter
Washington DC, USA
+4 year(s) experience
Michael is a regular at FDA's White Oak campus covering advisory committee meetings and public workshops on a variety of drug development areas. He has also written on a wide range of congressional hearings on topics such as drug pricing, user fee reauthorizations, opioids and the 21st Century Cures Act.
Michael is a weekly contributor to the Pink Sheet's "Keeping Track" column, and has authored several data-driven stories examining drug development trends. In his free time, Michael can be found cheering on - although often futilely - the New York Mets, Jets and Knicks.
Pink Sheet
AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.
Topic Cancer Clinical Trials
Pink Sheet
From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.
Pink Sheet
The Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1, with one abstention, in favor of approving Agile's transdermal contraceptive patch Twirla in a sharp divergence from the US FDA's negative evaluation of the drug, though it remains an open question of how the agency will ultimately come down.
Topic Drug review FDA
Pink Sheet
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
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
In an interview with the Pink Sheet, Marks said the guidances on regenerative medicines make clear what the agency will be enforcing.
Pink Sheet
US FDA Commissioner notes that combined-phase clinical trials could be expanded beyond oncology as one way of reducing drug development costs.
Pink Sheet
Merck previously disclosed the clinical hold on the three trials at the beginning of July
Topic Clinical trials
Generics Bulletin
31 Jan 2020
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09 Dec 2019
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06 Dec 2019
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05 Dec 2019
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03 Dec 2019
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01 Dec 2019
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26 Nov 2019
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25 Nov 2019
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20 Nov 2019
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17 Nov 2019
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13 Nov 2019
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12 Nov 2019
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11 Nov 2019
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10 Nov 2019
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07 Nov 2019
