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Regulatory
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Regulatory actions for March 23, 2023

March 23, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Athersys, Avadel, FSD, Iecure, Marinus, Mesoblast, Regeneron, Sandoz.
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Candida auris

Cidara prevails with US FDA approval of Rezzayo in candidemia, IC; partner Melinta to launch this summer

March 23, 2023
By Randy Osborne
Concerns voiced during January’s U.S. FDA advisory committee meeting failed to deter Cidara Therapeutics Inc. from winning approval by the agency March 22 for once-weekly Rezzayo (rezafungin for injection) to treat a pair of indications – candidemia as well as invasive candidiasis (IC) – in adults with limited or no alternatives.
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Product recall concept image

More troubles for patients needing Datascope IABP units

March 22, 2023
By Mark McCarty
The U.S. FDA reported yet another recall of intra-aortic balloon pumps made by Datascope Corp., an unfortunate development for patients in need of these devices that are still on the FDA’s list of devices that are in short supply. While no injuries or deaths have been reported in connection with the coiled connector cables that prompted the recall, the need to replace these cables could further crimp units needed to sustain patients during cardiac surgery procedures.
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Regulatory actions for March 22, 2023

March 22, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Wesper.
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Moderna vaccine vial and syringe on tray

Not just Moderna on the HELP hot seat

March 22, 2023
By Mari Serebrov
While Moderna Inc. CEO Stéphane Bancel was the one on the hot seat at a March 22 hearing before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, biopharma profitability in general, and capitalism itself, came under fire as committee Chair Bernie Sanders (I-Vt.) railed about corporate greed in the sector.
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US FTC: Apokyn suit has broad implications

March 22, 2023
By Mari Serebrov
Citing significant implications for patients with advanced Parkinson’s disease, as well as the broader public interest that’s at stake, the U.S. FTC filed an amicus brief in Sage Chemical Inc.’s district court challenge of Supernus Pharmaceuticals Inc.’s strategies to block generic competition of its injectable Parkinson’s drug, Apokyn (apomorphine).
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US PTO offers blessed relief for small inventors in new patent fee schedule

March 21, 2023
By Mark McCarty
As Medtronic plc. is fond of pointing out, the garage inventor has been the stuff of legend in U.S. business lore, providing a wide range of economically impactful inventions over the two-plus centuries since the U.S. patent system came into being.
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Edwards joins tech companies in challenging US PTO’s standard for inter partes reviews

March 21, 2023
By Mark McCarty
Edwards Lifesciences Inc., has joined Apple Inc., and several tech companies in suing the U.S. Patent and Trademark Office (PTO) over PTO’s administration of the inter partes review (IPR) process in a lawsuit that reached the Court of Appeals for the Federal Circuit. The court recently rejected the challenge as to whether the PTO is empowered by the statute to determine whether an IPR could be instituted, but the agency may be forced to engage in the clunky rulemaking process to formally encode the so-called Fintiv standard for acceptance of IPRs.
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Regulatory actions for March 21, 2023

March 21, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advamedica, Brainomix, Etiometry, Graymatters Health, Inspire Medical Systems, Viz.ai.
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Delayed stamp

Implementation of EU diagnostics reg forcing drug trial delays

March 21, 2023
By Mari Serebrov
The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey.
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