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BioWorld - Tuesday, June 10, 2025
Home » Topics » Regulatory

Regulatory
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Architectural pillars

Sotera leverages patent filed by Masimo CEO Kiani in invalidating Masimo’s ’218 patent

Oct. 5, 2023
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit has once again ruled on a patent dispute between Masimo Corp., of Irvine, Calif., and a rival firm, this time with Sotera Wireless Inc., of San Diego serving as the adversary. The Federal Circuit sided with Sotera in decreeing that 17 claims in Masimo’s RE47,218 (the ’218 patent) are invalidated due to the existence of prior art that rendered the claims obvious, but the irony in this litigation is that one of the patents cited by Sotera as prior art, the 6,597,933 patent, was authored in part by Joe Kiani, the founder, CEO and board chairman of Masimo.
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US FDA STARTs pilot to accelerate rare disease therapies

Oct. 5, 2023
By Mari Serebrov
The US FDA is offering sponsors of certain drugs and biologics more agency access as part of a pilot program that will be launching in January 2024 with the mission of accelerating the development of new therapies for rare diseases.
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M&A cityscape

Biopharma unites to remind US FTC that M&As are the PULSE of innovation

Oct. 5, 2023
By Mari Serebrov
Biopharma companies and industry advocates received the message the U.S. FTC intended to send when it broke new antitrust ground earlier this year in challenging Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. Now they’re uniting to send a message of their own – in the guise of an awareness campaign showing that the FTC’s new approach to M&A reviews and antitrust enforcement will undermine the ecosystem responsible for innovative and important therapies the world over.
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Xray showing lung cancer on tablet

Systemic polemic: ODAC panel BICRs over bias in Amgen’s Lumakras confirmatory trial, says no

Oct. 5, 2023
By Randy Osborne
The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
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Regulatory actions for Oct. 5, 2023

Oct. 5, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lipgems International, Precision Neuroscience.
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transcardiac access port
Patents

Connex Biomedical reveals its platforms for transcardiac access and device delivery

Oct. 5, 2023
By Simon Kerton
Connex Biomedical Inc. applied for patent protection for a transcardiac access port affixed and retained post-procedure on the cardiac muscle, such as the ventricular myocardium, and an access port delivery system configured to deliver the access port, secure the access port to the muscle tissue with tissue anchors, and provide a working channel through the access port to facilitate transcardiac access and device delivery.
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Regulatory actions for Oct. 5, 2023

Oct. 5, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acrotech, Bioxcel, Inhibikase, Novavax, Noxopharm, Takeda, Theratechnologies, Transcenta, Vedanta.
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Lumakras

Regulatory COPs grill ODAC briefing docs ahead of Lumakras adcom

Oct. 4, 2023
By Randy Osborne
Bad news for Amgen Inc. could mean upside for Mirati Therapeutics Inc., though the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) has yet to tell the tale regarding Lumakras (sotorasib), the former’s KRAS-G12C inhibitor.
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ODAC could set flexibility precedent for rare disease drugs

Oct. 4, 2023
By Mari Serebrov
After considering the evidence, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-6 Oct. 4 that the data from a single external-controlled trial and well-established preclinical animal models present sufficient evidence to demonstrate that US Worldmeds LLC’s DFMO (eflornithine) improves event-free survival in pediatric patients with high-risk neuroblastoma.
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Regulatory actions for Oct. 4, 2023

Oct. 4, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Calliditas, Fluoguide, Galderma, Maia, Novavax, Oxford, Urogen.
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