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FDA finalizes counterfeit devices guidance

Nov. 11, 2022
By Mark McCarty
The U.S. FDA has wrapped up its guidance effort to deal with counterfeit devices, an effort that consumed roughly 11 months. That span of time had little discernible effect on the draft, however, as the final guidance seems to leave the draft’s explanation that future FDA guidances may refer to more than one section of the statute in references to the definition of a device.
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Ovarian cancer illustration

GSK’s PARP inhibitor limited in ovarian cancer after FDA OS review

Nov. 11, 2022
By Jennifer Boggs
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
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Microglia and myelin

Open label: Extension of PDUFA less troubling as TG’s ublituximab makes headway in regulatory talks

Nov. 11, 2022
By Randy Osborne
With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.
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Regulatory actions for Nov. 11, 2022

Nov. 11, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Novocure, Trireme Medical.
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FTC promises to get tough on anticompetitive tactics

Nov. 11, 2022
By Mari Serebrov
Acting on its new promise to restore “rigorous enforcement” of the U.S. ban on unfair methods of competition, the FTC filed an amicus brief Nov. 10 supporting Avadel CNS Pharmaceuticals LLC’s motion to delist a Jazz Pharmaceuticals Inc. patent from the FDA’s Orange Book.
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SEC targets two men for insider trading

Nov. 11, 2022
Viatris Inc.’s chief information officer, Ramkumar Rayapureddy, is facing an SEC insider trading complaint, along with criminal charges brought by the fraud division of the U.S. Department of Justice. Another man, Brian Wong, was charged with illegal trading ahead of Merck & Co. Inc.’s acquisition of Pandion Therapeutics Inc.
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Inflation rebate not the only new Medicare payment

Nov. 10, 2022
By Mari Serebrov
In addition to the Medicare inflation rebate and the other pricing reforms of the Inflation Reduction Act, manufacturers of certain Part B drugs will be subject to a refund provision tucked away in the Infrastructure Investment and Jobs Act that was signed into U.S. law last year.
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US FDA cites aseptic failures with key chemo drug

Nov. 10, 2022
By Mari Serebrov
The U.S. FDA hit a Phoenix-based Abraxis Biosciences LLC facility with a warning letter citing out-of-control aseptic manufacturing processes for Abraxane (paclitaxel), a key chemotherapy drug. The letter, posted Nov. 8, noted that multiple media fill failures occurred last year during simulated aseptic processing operations on the Abraxane filling line.
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Regulatory actions for Nov. 10, 2022

Nov. 10, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin.
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Regulatory actions for Nov. 10, 2022

Nov. 10, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biomebank, Eikonoklastes, Nfl, Novartis, Oryzon, Regeneron, Xilio.
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