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BioWorld - Thursday, June 26, 2025
Home » Topics » Regulatory

Regulatory
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CRL for Zealand Pharma's glepaglutide; Novo’s Cagrisema disappoints

Dec. 20, 2024
By Nuala Moran
Shares in Zealand Pharma A/S (CO:ZEAL) dropped 22.4% to as low as DKK587 (US$82.16) on Dec. 20, after the U.S. FDA issued a complete response letter (CRL) for glepaglutide in the treatment of short bowel syndrome.
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Merit Wrapsody

Merit unwraps Wrapsody endoprosthesis PMA for the holidays

Dec. 20, 2024
By Holland Johnson
Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.
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OP5_INSU_POD_PDM_NoADH_RIGHT_RGB.jpg

New partnerships, approvals pump prospects for insulin delivery devices

Dec. 20, 2024
By Annette Boyle
A spate of year-end collaborations highlights growing enthusiasm for expanding use of automated insulin delivery devices or pumps in management of type 1 diabetes only to include many patients with type 2 diabetes. Beneficiaries include pump makers Tandem Diabetes Care Inc., Insulet Corp. and Medtronic plc as well as the leaders in the continuous glucose monitoring market, Abbott Laboratories and Dexcom Inc.
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DermR collection device

Skin cancer study: Dermr patch as effective as skin biopsy

Dec. 20, 2024
By Tamra Sami
A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain or cutting.
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Two more biopharma insider trading cases resolved

Dec. 19, 2024
By Mari Serebrov
A principal investigator and a former biopharma executive are the latest to reach settlements with the SEC to resolve charges of insider trading involving drug companies. Sai-Hong Ignatius Ou, of the University of California Irvine, agreed to a judgment ordering him to disgorge more than $1.5 million and to pay a civil penalty of the same amount. In a separate, unrelated settlement, Curt Dewitz, a former executive of an undisclosed biopharma company, agreed to disgorge about $70,383 in unlawful profits.
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Hand holding FDA blocks

Uncertainty builds at US FDA with retirements, CR questions

Dec. 19, 2024
By Mari Serebrov
The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31. After more than half a century at the FDA’s drug center, Temple has become the backbone of CDER’s new drug program, providing expertise and stability as other personnel have come and gone.
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Any Betta? FDA adds Ensacove to ALK lung cancer weaponry

Dec. 19, 2024
By Randy Osborne
A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
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3D illustration of mesenchymal stem cells

Mesoblast scores first US nod for mesenchymal stromal cell therapy

Dec. 19, 2024
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents.
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Medical vector illustration showing cross section of an eyeball with close up of the macula
Ocular

Vigeneron’s mRNA trans-splicing gene therapy for Stargardt disease receives IND clearance

Dec. 19, 2024
Vigeneron GmbH has received IND approval from the FDA for VG-801, a novel mRNA trans-splicing gene therapy to treat Stargardt disease and other retinal dystrophies associated with mutations in the ABCA4 gene. IND clearance enables initiation of a phase I/II trial, with a clinical trial application (CTA) submission to the EMA also planned in the coming months.
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U.S. Capitol and $100 bills

Congress wrapping up US spending bill as clock ticks down

Dec. 18, 2024
By Mari Serebrov
With no time to spare, the U.S. Congress is coming together on a continuing resolution (CR) to keep the federal government running beyond Dec. 20. Intended to fund the government at current levels through March 14, the CR itself is temporary. But of the 1,500-plus pages in the package House leadership released late Dec. 17, only about 100 pages pertain to the actual CR. More than a third of the package is devoted to the health-care sector.
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