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Regulatory
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Regulatory actions for Sept. 8, 2022

Sep. 8, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerin Medical, Cardior, Ceribell, Quest Diagnostics, Sciton.
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New age for wrinkle therapy dawns with Revance’s Daxxify win

Sep. 8, 2022
By Randy Osborne
The U.S. FDA’s approval of Revance Therapeutics Inc.’s Daxxify (daxibotulinumtoxinA-lanm) for the temporary improvement of moderate to severe glabellar lines, or frown lines, in adults, positioned the drug to compete with Abbvie Inc.’s blockbuster, Botox (onabotulinumtoxinA), which tallied $678 million in global net revenues for the second quarter of 2022.
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Regulatory actions for Sept. 8, 2022

Sep. 8, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelink, Advanced Accelerator, Ammax, Edgewise, Eledon, Fresenius, FSD, Gilead, Iecure, Lytix, Moleculin, Myrtelle, Pfizer, Praxis, Rhythm, Sarepta, Seres, Spero, Tarsus, Viracta.
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Claims that a few drops of blood can suffice for a test feed another diagnostic fraud case

Sep. 8, 2022
By Mark McCarty
The litigation over the fraud perpetrated by Theranos Inc. and its executives is still legally relevant, but another Silicon Valley company and its founder have been indicted over misrepresentations to investors over liquid biopsy technologies that were purported to work with just a few drops of blood. A jury recently convicted Mark Schena, the president of Palo Alto-Calif.-based Arrayit Corp., of defrauding investors and causing false claims to be submitted to federal health programs, another example of how investors can be easily misled by hucksters plying the diagnostics trade.
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Phillips Recall Mask BiPAP CPAP

Nightmare continues for Philips with recall issued for additional 17M masks

Sep. 7, 2022
By Annette Boyle
For a company that dominates the market for devices designed to improve breathing during sleep, Royal Philips NV has had the devil of time catching its own breath over the last 15 months as it has issued wave after wave of recalls.
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Regulatory actions for Sept. 7, 2022

Sep. 7, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Serpex Medical, Viewray.
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Regulatory actions for Sept. 7, 2022

Sep. 7, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Amylyx, Aston, Astrazeneca, Bausch + Lomb, Novaliq, Novavax, Tenaya.
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Cardiovascular

Tenaya cleared to begin clinical testing of TN-301 for HFpEF

Sep. 7, 2022
Tenaya Therapeutics Inc. has received FDA clearance of its IND application to begin clinical testing of TN-301, a highly selective small-molecule inhibitor of histone deacetylase 6 (HDAC6) initially being developed for heart failure with preserved ejection fraction (HFpEF).
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Cancer cell destruction by nanoparticles
Cancer

Monte Rosa receives IND clearance for molecular glue degrader MRT-2359 for MYC-driven solid tumors

Sep. 7, 2022
Monte Rosa Therapeutics Inc. has received FDA clearance of its IND application for MRT-2359, a potent and selective GSPT1-directed molecular glue degrader (MGD).
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European Commission headquarters

EC ruling makes Illumina divestiture of Grail likely

Sep. 6, 2022
By Annette Boyle
Thirteen months after Illumina Inc. and Grail Inc. merged, prior to regulatory approval, the deal has taken a turn for the worse. The prognosis looked better following an administrative law judge’s ruling Sept. 1 against the U.S. Federal Trade Commission’s lawsuit seeking to block the transaction, but the European Commission (EC) issued a decision Sept. 6 prohibiting the deal based on the likelihood that a merger would stifle innovation and limit choices in the early cancer detection liquid biopsy market.
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