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Home » Topics » Regulatory

Regulatory
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Sanders decries NIH’s ‘become-a-billionaire program’

Oct. 24, 2023
By Mari Serebrov
U.S. Sen. Bernie Sanders (I-Vt.) is calling for an investigation into the NIH’s proposed grant of an exclusive patent license for a late-stage cervical cancer drug to a small company linked to a former NIH researcher.
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Zymfentra

Biosimilar maker strides into ‘biobetter’ territory

Oct. 24, 2023
By Mari Serebrov
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
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US FDA’s tweak to COVID remote monitoring guidance a nod to health equity

Oct. 24, 2023
By Mark McCarty
The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas.
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Ribbons of digital data

Government groups team up on change control guiding principles

Oct. 24, 2023
By Mark McCarty
The U.S. FDA, Health Canada, and the U.K. Medicines and Healthcare Products Regulatory Agency have once again sidestepped the usual mechanisms for international regulatory cooperation to strike a blow for harmonization.
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Regulatory actions for Oct. 24, 2023

Oct. 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Bifurcation Systmes, Life Molecular Imaging, Sintau Intl., Medinol, MTF Biologics, Think Surgical.
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Concept art for "cancer cells destroyed by oncogenic virus"
Immuno-oncology

FDA clears IND for systemic oncolytic vaccinia virus therapy ASP-1012 for solid tumors

Oct. 24, 2023
Kalivir Immunotherapeutics Inc. has announced FDA clearance of an IND application for a phase I study of ASP-1012 (formerly VET2-L2) in participants with locally advanced or metastatic solid tumors. The trial is expected to begin in the first quarter of next year.
Read More
Illustration comparing healthy vs. Huntington's disease neuron and brain
Neurology/Psychiatric

Skyhawk’s RNA splicing modifier for Huntington’s disease cleared for Australian trial

Oct. 24, 2023
Skyhawk Therapeutics Inc. has obtained Australian human research ethic committee (HREC) approval to conduct a phase I trial of SKY-0515 for Huntington’s disease.
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Pipet, test tubes, chemical structures
Cancer

Kancera’s fractalkine-blocking candidate cleared in Finland for phase I trial

Oct. 24, 2023
The Finnish regulatory agency (FIMEA) has approved Kancera AB’s application to conduct a phase I study of KAND-145, the company’s second-generation fractalkine-blocking candidate drug for cancer.
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Diagram showing parts of the eye
Ocular

Endogena Therapeutics’ candidate for geographic atrophy receives FDA clearance to enter clinic

Oct. 24, 2023
Endogena Therapeutics Inc. has received FDA clearance of its IND application for EA-2351 for geographic atrophy, an advanced form of age-related macular degeneration (AMD).
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Seastar gets third breakthrough nod for Selective Cytopheretic device

Oct. 23, 2023
Seastar Medical Holding Corp. was granted a third breakthrough device designation by the U.S. FDA for its Selective Cytopheretic device (SCD), a biomimetic membrane-based device used to treat patients with acute inflammatory conditions, which can cause organ failure and death. The latest designation is for its use in patients with hepatorenal syndrome. It follows other indications including cardiorenal syndrome and in adults with acute kidney injury (AKI).
Read More
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