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BioWorld - Wednesday, June 25, 2025
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Regulatory
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Regulatory actions for Dec. 28, 2022

Dec. 28, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Polarean Imaging.
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Regulatory actions for Dec. 28, 2022

Dec. 28, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genentech, Intercept, Ipsen, Janux, Kaken, Leo, Mediwound, Mindrank AI, Neuren, Neurocrine, Nova Mentis, Regeneron, Revive, Springworks, Valneva, Zielbio.
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Royal Philips headquarters

Philips says CPAP testing data still suggest no conspicuous health issues

Dec. 27, 2022
By Mark McCarty
Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree.
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Seekin’s cancer mutation detection kit receives CE-IVD mark

Dec. 27, 2022
By Zhang Mengying
Seekin Inc.’s cancer mutation detection kit Pancanseek for leukemia patients has received a CE-IVD mark, expanding the company’s reach in the testing space.
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‘22 in review

VALID Act left out of omnibus legislation for US fiscal year 2023 budget

Dec. 27, 2022
By Mark McCarty
Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to designate academic research centers as centers of excellence for continuous drug manufacturing. A conspicuous omission from the omnibus was the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for FDA regulation of lab-developed tests (LDTs), an omission that drew both praise and criticism from stakeholders.
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FDA approved icons and medical professional

Genentech gets an early approval for follicular lymphoma therapy

Dec. 27, 2022
By Lee Landenberger
Two weeks ahead of its Jan. 6, 2023, PDUFA date, the U.S. FDA has approved the bispecific Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. It’s the first bispecific antibody approved for treating any type of non-Hodgkin lymphoma (NHL). FL is the most common slow-growing form of NHL.
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Inflation Reduction Act first major US victory on Rx prices, but likely not the last

Dec. 27, 2022
By Mari Serebrov
Topping biopharma regulatory news in 2022 was the signing of the Inflation Reduction Act (IRA), as its provisions requiring Medicare to directly negotiate certain prescription drug prices will open the door for the first time to a degree of government price controls in the U.S., affecting the bottom line of drug companies around the world.
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Sciclone gets green light for naxitamab for patients with neuroblastoma in China

Dec. 27, 2022
By Doris Yu
Sciclone Pharmaceuticals Holdings Ltd. has obtained marketing approval in China for Danyelza (naxitamab) for patients with relapsed or refractory high-risk neuroblastoma. The drug, in combination with granulocyte macrophage colony-stimulating factor, was approved to treat pediatric patients aged 1 and above, as well as adults, who have relapsed or refractory high-risk neuroblastoma in the bone or bone marrow and have demonstrated a partial or minor response to prior therapy or stable disease.
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Regulatory actions for Dec. 27, 2022

Dec. 27, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Si-Bone.
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Regulatory actions for Dec. 27, 2022

Dec. 27, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Adaptimmune, Antengene, Basilea, Biogen, Brainstorm, Celltrion, Coherus, Daiichi Sankyo, DBV, Deka, Disc, Eisai, Elpiscience, Immutep, Junshi, Kite, Relief.
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