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Home » Topics » Regulatory

Regulatory
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Brain clay model
Neurology/Psychiatric

FDA clears IND for Jaguar’s JAG-201 for genetic form of ASD and Phelan-McDermid syndrome

Feb. 1, 2024
Jaguar Gene Therapy LLC’s IND application for JAG-201, a gene therapy for a genetic form of autism spectrum disorder (ASD) and Phelan-McDermid syndrome (PMS; 22q13.3 deletion syndrome), has been cleared by the FDA.
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Human NK cell
Immuno-oncology

23andme’s NK cell activator cleared to enter clinic for solid tumors

Feb. 1, 2024
23andme Holding Co. has received FDA clearance of its IND application for 23ME-01473 (‘1473), a dual mechanism antibody and natural killer (NK) cell activator intended to treat cancer.
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US CMS to negotiate sickle cell gene therapy agreements

Jan. 31, 2024
By Mari Serebrov
Newly approved gene therapies targeting sickle cell disease will be the first focus of the U.S. Centers for Medicare & Medicaid Services’ (CMS) Cell and Gene Therapy Access Model, the agency said Jan. 30.
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U.S. Securities and Exchange Commission

US SEC sticks to perpetual gag rule in settlements

Jan. 31, 2024
By Mari Serebrov
The U.S. SEC denied a petition asking it to amend its 50-year-old no-admit/no-deny settlement policy that slaps a perpetual gag on parties that opt to resolve SEC allegations through settlements rather than in court.
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EU flags at European Commission building

Europabio: Proposed EU legislation risks sabotaging innovation

Jan. 31, 2024
By Nuala Moran
The EU’s proposed update of its pharmaceutical legislation will break the model of small companies acting as the vehicle for translating Europe’s rich research base for onward development by pharma, according to an analysis looking specifically at the impact the new rules would have on the biotech sector.
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U.S. at night from space with circuit board overlay

FDA staff can access management meeting notes in QMSR final rule

Jan. 31, 2024
By Mark McCarty
The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.
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FARAPULSE pulsed field ablation system

Boston Sci’s Farapulse approval intensifies PFA competition

Jan. 31, 2024
By Annette Boyle
The U.S. FDA added a second pulsed field ablation (PFA) system to the approved list with its greenlight for Boston Scientific Corp.’s Farapulse for treatment of atrial fibrillation (AF). Farapulse joins Medtronic plc’s Pulseselect, which garnered FDA approval in December. Two other PFA devices scored regulatory wins since the new year: Biosense Webster inc.’s Varipulse secured approval from the Japanese Ministry of Health Labor and Welfare and Sichaun Jinjiang Electronic Medical Device Technology Co. Ltd. got the nod from China’s National Medical Products Administration.
Read More
Flag of South Korea with skyscrapers in the background

Genexine files for Korea approval of Efesa for CKD-linked anemia

Jan. 30, 2024
By Marian (YoonJee) Chu
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
Read More

Australia takes first steps toward meaningful reforms to health technology process

Jan. 30, 2024
By Tamra Sami
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
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Toy bulldozer moving FDA letter blocks

FDA’s real-world evidence draft expands data requirements

Jan. 30, 2024
By Mark McCarty
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
Read More
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