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Regulatory
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Regulatory actions for Feb. 15, 2023

Feb. 15, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Qiagen.
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Regulatory actions for Feb. 15, 2023

Feb. 15, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Athersys, Avidity, Biocon, Healios, Lemonex, Mirum, Neurona, Soligenix, Verve, Viatris.
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Patent illustration

Patent loss to Colibri unlikely to dampen Medtronic’s fortunes in TAVR market

Feb. 14, 2023
By Mark McCarty
The patent wars over the design of transcatheter aortic valve replacement (TAVR) devices seemed to disappear roughly nine years ago, but there is at least one more episode for Dublin-based Medtronic plc before the company could lay the issue to rest. A jury declared that Medtronic is liable for more than $100 million in damages over alleged infringement of a patent held by Broomfield, Colo.-based Colibri Heart Valve LLC, but the contested patent has expired, and Medtronic said it intends to pursue the matter further.
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Gavel and First Amendment

US False Claims actions up in 2022, but dollar value of settlements flat over 2021

Feb. 14, 2023
By Mark McCarty
The False Claims Act (FCA) is perhaps the primary vehicle for U.S. federal authorities to extract penalties and fines from life science companies for violations of the law, but a new report by Gibson Dunn & Crutcher LLP suggests a mixed signal. The report notes that the U.S. Department of Justice (DOJ) recovered $2.2 billion via the FCA last year, but while that is not a conspicuous number for the past decade plus, what was conspicuous was that those sums were recovered by the second highest level of FCA actions settlement in the history of the FCA, suggesting that DOJ is keen on enforcement with no regard to the size of the target.
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Prior authorization reform needed now, US CMS told

Feb. 14, 2023
By Mari Serebrov
In decrying high U.S. drug prices, lawmakers often cite statistics about the number of patients who forgo or ration their prescriptions because of the out-of-pocket cost. Those discussions overlook the role payer utilization management tactics, including prior authorization, may play in patients abandoning their treatment, be it a specific drug or an imaging service.
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FDA sign

Soligenix considers its options for dealing with refusal to file letter

Feb. 14, 2023
By Lee Landenberger
Soligenix Inc. is scratching its chin as it decides how to react to the U.S. FDA’s refusal to file letter regarding Hybryte (synthetic hypericin) for treating early stage cutaneous T-cell lymphoma. The letter means the FDA won’t review the application, which was submitted in December, because there are deficiencies that cannot promptly be resolved, rendering the application essentially incomplete.
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US FDA looks to expand transparency to adcom guest speakers

Feb. 14, 2023
To increase transparency at its advisory committee (adcom) meetings, the U.S. FDA is proposing asking guest speakers to voluntarily disclose their financial interests and professional relationships to determine their eligibility to give a presentation at an adcom meeting.
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USPTO wants to know: What happens when AI truly invents

Feb. 14, 2023
By Mari Serebrov
With an eye toward the future, the U.S. Patent and Trademark Office (USPTO) is seeking comment on artificial intelligence (AI) technologies and inventorship issues that may arise as AI takes on a bigger role in innovation.
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USITC to investigate NASH trade secret fight

Feb. 14, 2023
By Mari Serebrov
The U.S. International Trade Commission (USITC) is launching an investigation into the importation from China of certain thyroid hormone receptor-beta agonists, products containing them and the manufacturing processes being used.
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Virtual IP display

Lots of changes coming to China IP scene, but improvement slow

Feb. 14, 2023
By Mari Serebrov
With China taking steps to enact or propose amendments to more than 60 intellectual property (IP)-related laws and regulations over the past few years, drug and device companies doing business in the country need to keep abreast of the changes. Despite China’s efforts, most of the participants in the Feb. 9 U.S. Patent and Trademark Office’s quarterly China IP webinar indicated in a pre-webinar survey that they have yet to see much of an improvement in China’s enforcement and regulation of IP rights.
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