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Home » Topics » Regulatory

Regulatory
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Martin Makary, nominee for U.S. FDA commissioner

US FDA nominee HELPed on the way to confirmation

March 6, 2025
By Mari Serebrov
Martin Makary, President Donald Trump’s pick to head the U.S. FDA, took his turn before the Senate Health, Education, Labor and Pensions (HELP) Committee March 6, a week ahead of the committee’s confirmation votes on both him and Jay Bhattacharya as the next NIH director. The committee votes will set the stage for the full Senate to vote on confirming both nominees later this month.
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Neurotech ECT illustration

Neurotech’s CNTF implant approved for macular telangiectasia

March 6, 2025
By Jennifer Boggs
The first treatment for macular telangiectasia type 2 is set to enter the market following U.S. FDA approval of NT-501 (revakinagene taroretcel) from Neurotech Pharmaceuticals Inc., a privately held company that has been quietly advancing its encapsulated cell therapy platform for more than two decades.
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Cancer immunotherapy illustration
Immuno-oncology

CSPC’s bifunctional fusion protein cleared for trials in China

March 6, 2025
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with JMT-108 for advanced malignant tumors.
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Jay Bhattacharya, nominee for U.S. NIH director

Bhattacharya shares his vision for US NIH

March 5, 2025
By Mari Serebrov
Jay Bhattacharya will have his work cut out for him if he wins confirmation as the next director of the U.S. NIH. Besides getting NIH committees back on track to evaluate grant applications and calming the fears of researchers and other staff who have seen about 1,200 colleagues cut from their ranks in recent weeks, Bhattacharya will face the task of rebuilding public trust in the NIH itself.
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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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