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BioWorld - Tuesday, March 17, 2026
Home » Topics » Regulatory

Regulatory
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Regulatory actions for Oct. 5, 2020

Oct. 5, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Chembio, Haemonetics, Histosonics, Pixcell Medical, Quidel.
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End of the road for Makena?

Oct. 5, 2020
By Mari Serebrov
Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA is proposing its withdrawal from the U.S. market because the required postmarketing study didn’t show clinical benefit.
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Regulatory actions for Oct. 5, 2020

Oct. 5, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Carsgen, Eyevensys, Immunogen, Taigen.
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Regulatory front

COVID-19 claims, sponsored link catch OPDP eye

Oct. 5, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Clinical trial fraud brings 28-year prison sentence.
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Songbird flying high with Health Canada approval of double biomarker COVID-19 test device

Oct. 2, 2020
By David Godkin
TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north.
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Medtronic gets FDA nod for expanded labeling with Resolute Onyx DES

Oct. 2, 2020
By Liz Hollis
Medtronic plc’s winning streak continued this week with the announcement that the U.S. FDA had given its nod for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES). The approval is based on results from the Onyx ONE Clear Study that evaluated about 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx.
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Coronavirus vs U.S. wrecking balls

Parry and riposte the main theme at House pandemic hearing

Oct. 2, 2020
By Mark McCarty
The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time.
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Regulatory front for Oct. 2, 2020

Oct. 2, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Rockefeller Foundation.
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Regulatory actions for Oct. 2, 2020

Oct. 2, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dascena, Labcorp, OralDNA Labs.
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Study in a box: Pharmacyte’s IND in pancreatic cancer put on hold

Oct. 2, 2020
By Lee Landenberger
Pharmacyte Biotech Inc. is now in a series of 30-day cycles with the FDA as a planned phase IIb study of its lead candidate has been placed on hold. On Sept. 2, Pharmacyte submitted its IND for a phase IIb trial of its product, known as Cypcap, in locally advanced, inoperable pancreatic cancer and, on Oct. 2, the company said the FDA placed the application on hold.
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