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3D illustration of knee joint

PTAB affirms rejection of 2014 patent application for cartilage

March 5, 2025
By Mark McCarty
The widespread need for cartilage repair may have bred optimism on the part of Spinalcyte LLC when it filed a related patent in 2014, but the Patent Trial and Appeal Board has affirmed a rejection of the patent due to lack of enablement, an object lesson regarding the need for clarity in patent applications.
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FDA icons and doctor

FDA draft for OI contrast agents allows intrasubject comparators

March 5, 2025
By Mark McCarty
The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.
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3D illustration demonstrating CAR T therapy
Immuno-oncology

Bioheng Therapeutics’ CD7-targeted universal CAR T-cell therapy gains IND clearance

March 5, 2025
Bioheng Therapeutics US LLC has obtained IND approval from the FDA for CTD-402, a CD7-targeted universal CAR T-cell therapy, for the treatment of pediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma.
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Infant legs and feet
Gastrointestinal

Neurenati’s NEU-001 awarded orphan drug designation for Hirschsprung disease

March 5, 2025
Neurenati Therapeutics Inc.’s NEU-001 has been awarded U.S. orphan drug and rare pediatric disease designations by the FDA for the treatment of Hirschsprung disease.
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Ryoncil

Mesoblast prices pediatric stem cell treatment at $1.55 million

March 4, 2025
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
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Australia’s TGA rejects Eisai’s Leqembi again

March 4, 2025
By Tamra Sami
Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.
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Trump’s EOs keep coming as US agencies await new leadership

March 4, 2025
By Mari Serebrov
The executive orders (EOs) pouring out of the Trump White House, and the resulting court challenges, continue to pile up, deepening the uncertainty hanging over the life sciences sector and the U.S. economy in general.
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Illustration of tumor on kidney

FDA accepts Telix BLA for kidney cancer imaging agent

March 4, 2025
By Tamra Sami
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
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canada-court-regulatory.png

Health Canada jumps into PCCP filings for machine learning

March 4, 2025
By Mark McCarty
The world of machine learning-enabled medical technology is advancing rapidly, and regulators are struggling to keep up, and Health Canada has joined the ranks of regulators who are tackling these technologies.
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Product recall concept image

Philips pulls Tack device due to problems with deployment

March 4, 2025
By Mark McCarty
Royal Phillips NV opted to withdraw the Tack endovascular repair device only six years after the U.S. FDA’s approved it. Tack is designed to repair vascular dissection caused by angioplasty. The associated recall lists 20 injuries and no fatalities, but the device design might be a culprit in forcing the withdrawal of the Tack.
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