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Home » Topics » Regulatory

Regulatory
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Zevra’s arimoclomol on track as GeMDAC backs NPC drug by 11-5

Aug. 2, 2024
By Randy Osborne
As the Sept. 21 PDUFA date looms for arimoclomol from Zevra Therapeutics Inc. in Niemann-Pick type C (NPC), the U.S. FDA’s newly formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) decided in favor of the drug.
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Cancer cell, dropper, test tubes

First in a decade: FDA clears Adaptimmune T-cell therapy Tecelra

Aug. 2, 2024
By Lee Landenberger
A T-cell therapy from Adaptimmune Therapeutics plc has received accelerated approval from the U.S. FDA to treat advanced synovial sarcoma (SS). Tecelra (afamitresgene autoleucel), a CAR T targeting MAGE-A4, is the first engineered T-cell therapy for solid tumors and the first treatment option for the indication in more than a decade.
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Liver and DNA
Genetic/congenital

IN-016 granted orphan status for progressive familial intrahepatic cholestasis therapy

Aug. 2, 2024
Innorna Co. Ltd.’s IN-016 has received orphan drug status from the U.S. FDA for the treatment of progressive familial intrahepatic cholestasis (PFIC). Earlier in July, IN-016 had been granted Rare Pediatric Disease Designation. PFIC is a group of rare genetic disorders associated with defects in bile acid secretion or transport, resulting in unwanted bile accumulation within the liver.
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Gavel and FTC logo

Trade associations push back on US PTO’s terminal disclaimer proposal

Aug. 1, 2024
By Mark McCarty
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
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US flag, gavel, book

Maker of hip resurfacing system defeats US lawsuit via preemption

Aug. 1, 2024
By Mark McCarty
U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.
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Laptop displaying FDA logo

FDA issues refusal to file letter for Telix imaging agent

Aug. 1, 2024
By Tamra Sami
Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
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3D illustration demonstrating CAR T therapy
Cancer

In situ CAR T receives IND clearance

Aug. 1, 2024
Umoja Biopharma Inc. has received clearance from the FDA to begin a first-in-human trial of its CAR T product UB-VV111. The company expects to dose the first patient by the end of 2024.
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Hepatitis B virus rendering
Infection

Recombinant polyclonal HBV therapy cleared to enter clinic

Aug. 1, 2024
Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-2339 for the treatment of hepatitis B virus (HBV) infections.
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Gavel and FTC logo

Trade associations push back on US PTO’s terminal disclaimer proposal

July 31, 2024
By Mark McCarty
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
Read More

New FDA adcom to consider Niemann-Pick drug at debut meeting

July 31, 2024
By Mari Serebrov
Zevra Therapeutics Inc. will make its case Aug. 2 for its Niemann-Pick type C (NPC) candidate, arimoclomol, when the U.S. FDA’s Genetic Metabolic Diseases Advisory Committee (GeMDAC) meets for the first time.
Read More
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