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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exelixis, Gracell, Iaso, Ironwood, Jubilant, Nrx, Ocuphire, Pfizer, Pharmazz, Sairopa.
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.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Everest, GSK, Phathom.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Bellerophon, Medicinova, Mesoblast, Regeneron.
U.S. drug prices continue to be in the crosshairs of Congress, with the Senate Judiciary Committee once again sending five bipartisan bills targeting anticompetitive pricing tactics to the full Senate Feb. 9 with do-pass recommendations.
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.
Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s experimental COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) 23% on Feb. 9 as the company continues to seek regulatory approval. That approval path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annovis, Appili, Leo, Neurosense, Santhera, UCB.
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