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BioWorld - Sunday, March 15, 2026
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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Med-tech fraud charges lead to prison time

March 9, 2026
By Mari Serebrov
No Comments
Patrick Cassells, of Fulshear, Texas, was sentenced March 6 to more than seven years in prison and ordered to pay more than $25 million in restitution and forfeiture after he pleaded guilty nearly two years ago to one count of health care fraud that involved the three durable medical equipment companies he owned and operated.
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Eli Lilly commits $500M to boost South Korea’s biomedical sector

March 9, 2026
By Marian (YoonJee) Chu
No Comments
Eli Lilly and Co. will invest $500 million to support South Korea’s biopharmaceutical industry over the next five years, following high-level talks March 9 between Prime Minister Kim Min-seok and Lilly Executive Vice President Patrik Jonsson.
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Taiwan President Lai Ching-te presides over the seventh meeting of the Healthy Taiwan Promotion Committee.

Taiwan to invest $752M in biopharma security over four years

March 9, 2026
By Marian (YoonJee) Chu
No Comments
Taiwan plans to invest NT$24 billion (US$752 million) over four years to bolster national biosecurity, expand domestic pharmaceutical production and safeguard against global supply chain volatility.
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Rare disease illustration

Forecast brighter for Uniqure with Prasad’s departure?

March 9, 2026
By Mari Serebrov
No Comments
The regulatory clouds that have been darkening the U.S. FDA landscape of late for Uniqure NV’s gene therapy AMT-130 in Huntington’s disease may be parting a bit with the announced departure of Vinay Prasad as director of the agency’s CBER at the end of April.
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Claire, an AI-powered imaging device

Perimeter gets FDA nod for imaging device for breast cancer surgery

March 6, 2026
By Shani Alexander
No Comments
Perimeter Medical Imaging AI Inc. secured FDA premarket approval for Claire, its AI-powered imaging device which detects difficult-to-see cancer during breast-conserving surgery. Claire combines AI with wide-field optical coherence tomography to provide surgeons with high-resolution, real-time views of excised tumor margins, to reduce the need for re-operations.
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Induced pluripotent stem cells

Japan approves first iPSC therapy for Parkinson’s disease

March 6, 2026
By Tamra Sami
No Comments
Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.
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Korea ARPA-H roundtable

Korean ARPA-H to invest ₩162B in nine projects in 2026

March 6, 2026
By Marian (YoonJee) Chu
No Comments
The K-health MIRAE Initiative, also known as Korean ARPA-H, announced plans to allocate about ₩162 billion (US$110 million) in nine new projects over the next five years, with a focus on strengthening national health security.
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MOHW Minister Jeong Eun Kyeong and Jörg-Michael Rupp, Roche

Roche to invest ₩710B in South Korea over five years

March 5, 2026
By Marian (YoonJee) Chu
No Comments
Roche Holding AG pledged to invest ₩710 billion (US$484.6 million) in South Korea over the next five years, positioning the country as a major global hub for clinical trials. The near $500 million agreement inked with the Korean government will bring Roche’s clinical trials for common or incurable diseases and innovative biopharmaceutical products to the country.
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Person holding weight with assistance

FDA curtails Pepgen’s Freedom2 operate in DM1

March 5, 2026
By Randy Osborne
No Comments
Pepgen Inc. is forging ahead with tests of PGN-EDODM1 in other territories after the U.S. FDA placed a partial hold on the Freedom2-DM1 phase II trial, a multiple ascending-dose, randomized, placebo-controlled experiment in myotonic dystrophy type 1 (DM1).
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Fallopian tubes, ovaries and uterus

China approves first noninvasive therapy for cervical precancer

March 4, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.
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