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Bill Would Prevent Conflicting FDA Consultant Contracts
[404 Words]
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| A Senate bill seeks to bar conflicts of interest in consulting contracts, such as those FDA signed with McKinsey & Co. on regulatory actions involving opioids while the company was also advising opioid maker Purdue Pharma. |
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03/28/2022
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Drug User Fee Notice Correction
[75 Words]
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| Federal Register notice: FDA corrects an 8/16/2021 notice entitled “Prescription Drug User Fee Rates for Fiscal Year 2022.” |
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03/25/2022
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Review Extension Bristol-Myers sBLA for Reblozyl
[134 Words]
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| Reblozyl is currently approved to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes in patients who did not respond adequately to an erythropoietin-stimulating agent and requiring red blood cell transfusions. |
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03/25/2022
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BMS Resolves Abraxane Drug Shortage
[313 Words]
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| Bristol-Myers Squibb says it has resolved manufacturing constraints that led to “global supply challenges” for Abraxane for injectable suspension. |
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03/25/2022
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FDA PI3K Concerns Hits MEI Pharma’s Zandelisib
[538 Words]
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| Ongoing FDA concerns about PI3K inhibitors prompts the agency to discourage MEI Pharma and Kyowa Kirin from seeking accelerated approved of a BLA for zandelisib based on data from their single-arm Phase 2 TIDAL study. |
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03/25/2022
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House Panel Grills FDA on Medtronic Heart Pump
[379 Words]
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| The House Oversight and Reform committee asks FDA for answers to what regulatory enforcement actions it sought against Medtronic’s troubled HeartWare Ventricular Assist Device (HVAD) System — a recalled heart pump device associated with more than 20,000 patient injuries and 3,000 deaths. |
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03/25/2022
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Senate Passes Marijuana/CBD Research Bill
[348 Words]
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| The Senate passes the “Cannabidiol and Marijuana Research Expansion Act” that is intended to ensure that research on cannabidiol and other potentially beneficial marijuana-derived substances is based on sound science while reducing the regulatory barriers associated with conducting such research. |
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03/25/2022
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GSK/Vir Sotrovimab EUA Excludes New Variant Use
[140 Words]
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| FDA amends a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab because the 500mg therapy is unlikely to be effective in Covid-19 patients infected by the Omicron BA.2 variant. |
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03/25/2022
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