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.
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.
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.
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.
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.
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
The rash of firings at agencies of the Department of Health and Human Services has provoked a Feb. 28 letter from Reps. Dianna DeGette (D-Colo.) and Frank Pallone (D-N.J.), blasting the dismissals and insinuating that the dismissals were politically motivated.
The Apple Watch may be able to alert wearers to heart palpitations, but Google LLC’s Pixel Watch 3 can now detect when a user’s heart stops – and call emergency services. The pulse detection featured received clearance from the U.S. FDA on Feb. 26 and Google plans to make it available on its Pixel Watch 3 starting in March. Pulse detection is already available for watches sold in the U.K. and EU.
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
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