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Regulatory
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Regulatory actions for Sept. 6, 2022

Sep. 6, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Azurity, Bayer, Boehringer, Immuneering, Intellia, Moderna, Novavax, Y-mabs.
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Test tubes, capsules, dropper
Cancer

Cancer Immuneering submits IND application for IMM-1-104 for advanced RAS-mutant solid tumors

Sep. 5, 2022
Immuneering Corp. has submitted an IND application to the FDA to support a phase I/IIa trial of IMM-1-104, an oral once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
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Owkin wins CE mark for two AI cancer solutions

Sep. 2, 2022
By Nuala Moran
Owkin Inc. has secured CE marking for two first-in-class artificial intelligence (AI)-based diagnostics, marking a move from research use only and towards the mainstream for AI in enabling faster and more efficient analysis of digital pathology slides.
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FDA approved icons and medical professional

Boehringer grabs first FDA approval in rare form of psoriasis

Sep. 2, 2022
By Jennifer Boggs and Richard Staines
The U.S. FDA has become the first global regulator to approve Boehringer Ingelheim GmbH’s spesolimab, the first treatment specifically approved for generalized pustular psoriasis flares in adults, a rare and potentially fatal disease. Branded as Spevigo, it works by inhibiting interleukin-36 and is delivered via intravenous injection. Ingelheim, Germany-based Boehringer Ingelheim is not giving away details about pricing but Carinne Brouillon, a member of the company’s board responsible for human pharma, said Spevigo is “priced similarly to the other biologic therapies used to treat rare dermatologic diseases.”
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FDA draft for digital tech in clinical trials languishes despite agency’s digital push

Sep. 2, 2022
By Mark McCarty
The U.S. FDA’s formation of the Digital Health Center of Excellence was heralded as a key enabler of digital health technologies, but the news hasn’t necessarily had the expected effect. The agency’s December 2021 draft guidance on the use of digital health technologies to assist in the conduct of clinical trials is still in regulatory drydock.
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Regulatory actions for Sept. 2, 2022

Sep. 2, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Laseroptek.
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Regulatory actions for Sept. 2, 2022

Sep. 2, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Aston, Biontech, Genentech, Immusoft, Moderna, Pfizer, Roche, Sanofi.
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U.S. at night from space with circuit board overlay

FDA draft for digital tech in clinical trials languishes despite agency’s digital push

Sep. 1, 2022
By Mark McCarty
The U.S. FDA’s formation of the Digital Health Center of Excellence (DHCoE) was heralded as a key enabler of digital health technologies, but the news hasn’t necessarily had the expected effect. The agency’s December 2021 draft guidance on the use of digital health technologies to assist in the conduct of clinical trials is still in regulatory drydock.
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DeSantis presses Florida drug importation plan in run-up to election

Sep. 1, 2022
By Michael Fitzhugh
Irked by what state officials described as "bureaucratic roadblocks" to Florida's proposal for importing cheaper prescription drugs from Canada, Florida Gov. Ron DeSantis on Aug. 31 announced a state lawsuit against the U.S. FDA.
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ACIP blesses bivalent vaccines for US market

Sep. 1, 2022
By Mari Serebrov
In the hope of preventing thousands of hospitalizations and deaths over the next few months, the U.S. CDC’s Advisory Committee on Immunization Practice (ACIP) voted 13-1 Sept. 1 to recommend the use of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants as boosters.
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