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Home » Topics » Regulatory

Regulatory
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Samsung Biologics plant

Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

May 22, 2025
By Marian (YoonJee) Chu
No Comments
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
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ODAC Starglo vote could impact universe of trials

May 22, 2025
By Mari Serebrov
No Comments
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
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Dry, thick and raised patches on the skin of knees and elbows
Dermatologic

Ascletis Pharma’s oral IL-17 inhibitor cleared to enter clinic for plaque psoriasis

May 22, 2025
No Comments
Ascletis Pharma Inc. has announced IND clearance by the FDA for a phase I trial of ASC-50 for the treatment of mild to moderate plaque psoriasis. Dosing is expected to start in the third quarter of this year.
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Cancer cells
Cancer

Avenzo gains IND clearance for CDK4 inhibitor

May 22, 2025
No Comments
Avenzo Therapeutics Inc. has gained IND clearance from the FDA for AVZO-023 (formerly ARTS-023), a CDK4-selective inhibitor. The company also announced it has exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing and commercialization rights.
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Split adcom vote not what Urogen envisioned

May 21, 2025
By Mari Serebrov
No Comments
More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
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MHRA logo

MHRA drafting guidance for RW clinical studies control arm

May 21, 2025
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.
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U.S. FDA headquarters

GAO sees need for FDA guidance for organ-on-a-chip

May 21, 2025
By Mark McCarty
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

Fujirebio Alzheimer’s test wins first FDA clearance

May 20, 2025
By Annette Boyle
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
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Gavel-and-scales.png

Innovative Health bests J&J unit for anticompetitive practices

May 20, 2025
By Mark McCarty
Innovative Health LLC, of Scottsdale, Ariz., obtained a jury verdict of $147 million against Johnson & Johnson’s Biosense Webster unit for practices that thwarted the use of less costly reprocessed medical devices.
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Spinefrontier CEO enters guilty plea for false statement

May 20, 2025
By Mark McCarty
The U.S. Department of Justice said the CEO of Spinefrontier Inc., Kingsley Chin, entered a guilty plea in connection with allegations that he made false statements about payments made to surgeons for consulting work the physicians did not perform.
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