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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sunrise, Tasso.
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.
The U.S. Federal Trade Commission (FTC) has updated a 1998 compliance guidance for health care products, much of which reiterates the provisions of the legacy edition. However, this updated version calls for randomized, controlled clinical trials to substantiate any claims made in connection with medical devices.
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.
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